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Aurobindo Pharma Ltd.


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Series: EQ | ISIN: INE406A01037 | SECTOR: Pharmaceuticals

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Annual Report

For Year :
2019 2018 2017 2016 2015 2014 2013 2012 2011

Director’s Report


Dear Members,

The Directors are pleased to present the 32nd Annual Report of the Company together with the audited accounts for the financial year ended March 31, 2019.


Standalone financials_ _(Rs, in Million)



Revenue from operations



Profit before depreciation, interest, tax and Exceptional items






Finance cost



Profit before Tax



Provision for Tax



Net Profit after tax



Other Comprehensive Income/ (expense)



Total Comprehensive income for the period




Your Company has paid first interim dividend of 125% i.e. Rs,1.25 per equity share of Rs,1/- and second interim dividend of 125% i.e Rs,1.25/- per equity share of Rs,1/-. The total dividend for the financial year 2018-19 comes to 250% i.e. ''2.50 per equity share of Rs,1/- against 250% i.e ''2.50 per equity share of Rs,1/- paid in the previous year.

Pursuant to Regulation 43A of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, top five hundred listed entities based on market capitalization are required to formulate a Dividend Distribution Policy. The Board has approved and adopted the Dividend Distribution Policy and the same is available on the Company''s website about-us/governance/governance-policies/


Your Company achieved significant size and scale during the year. It is now globally the tenth largest generic Company by revenues and the second largest among the listed Indian pharmaceutical companies.

FY2018-19 was also the year during which your Company made significant acquisitions and investments to augment its global presence. In the US, it entered into a definitive agreement to acquire the portfolio of dermatology and oral solids businesses from Sandoz1 Inc. USA. The acquisition is expected to be completed in FY2019-20. Your Company also made inroads into the branded oncology market by acquiring seven marketed oncology branded injectable products from Spectrum Pharmaceuticals Inc.

The acquisition of Apotex Inc''s businesses opened doors to markets in the Eastern Europe. Your Company also acquired R&D assets from Advent Pharmaceuticals Pty Ltd., Australia boosting its R&D capabilities in the respiratory segment.

During the year, through its wholly owned subsidiary, Helix Healthcare BV Netherlands your Company invested in a joint venture with Shandong Luoxin in China.

On a standalone basis, your Company revenues registered a growth of 19.0% reaching Rs,122,578.9 million in FY2018-19, compared to Rs,103,031.5 million in the FY 2017-18. EBITDA for FY 2018-19 stood at ''24,092.9 million vs. ''26,700.0 million in FY2017-18. EBITDA margin was at 19.7%. Profit before Tax for the year at standalone level was Rs,19,646.2 million, decline of 16.1% compared to the preceding year. Your Company''s Net Profit (before OCI) was at Rs,15,297.3 million as against Rs,18,127.7 million in FY2017-18. The Diluted Earnings Per Share stood at ''26.11 compared to ''30.94 in FY2017-18.

On a consolidated basis, revenues for FY2018-19 grew by 18.6% from Rs,164,998.4 million in the previous year to Rs,195,635.5 million. The healthy growth in revenues were driven by new product launches across markets and an improvement in market share of the existing products. The formulations business registered a revenue growth of 19.4% and improved to Rs,161,570.3 million from Rs,135,331.8 million in the previous year. The Active Pharmaceutical Ingredients (APIs) business sales stood at ''34,030.3 million from ''29,622.3 million in the corresponding previous period, witnessing a growth of 14.9% year-on-year. EBITDA margin was at 20.2% vis-a-vis 23.0% in FY2017-18. EBITDA before forex and other income stood at ''39,519.4 million, witnessing a 4.3% growth y-o-y. Your Company reported a Net Profit of ''23,647.4 million. The Diluted Earnings Per Share stood at Rs,40.36 compared to Rs,41.36 in FY2017-18.

As on 31st March 2019, the Company filed 541 Abbreviated New Drug Applications (ANDAs) on a cumulative basis. Of the total count, 377 have received final approvals and 26 have got tentative approvals, including 9 ANDAs which are tentatively approved under the US President''s Emergency Plan for AIDS Relief (PEPFAR) and the balance 138 ANDAs are currently under review.

Your Company witnessed growth across key geographies in the formulations segment. The US business reported 21.3% growth to reach Rs,90,307.3 million and contributed 46.2% to the total revenues. The growth in revenues were driven by new product launches, along with an increase in the market share of existing products across the segments such as oral solids, injectables, dietary supplements and the over the counter (OTC) business.

Your Company registered a 13.9% growth in its Europe formulations business, as revenue touched Rs,49,601.7 million in FY2018-19 compared to the previous year''s revenue of Rs,43,543.8 million. With the Acquisition of Apotex''s businesses in five countries, Aurobindo strengthened its foothold in Europe.

It now operates in 11 countries and is present across multiple channels including pharmacy, hospital and tender sales.

Your Company’s formulations sales in Growth Markets including Brazil, Canada, Columbia and South Africa grew by 33.1% to Rs,11,936.5 million vis-a-vis Rs,8,971.3 million reported in FY2017- 18. The growth was largely driven by Canada. The Company now ranks amongst the top ten generic players in Canada. The growth in Canada was propelled by the approvals for a number of products and the Company’s ability to leverage these approvals.

The ARV formulations business reported a growth of 15.8% with revenues of Rs,9,724.8 million vis-a-vis Rs,8,395.8 million a year ago. During the year, the Company was awarded a supply contract from South African government for Dolutegravir triple combination and related products, dispatches for which will begin in FY2019-20.


Your Company will continue to expand its market penetration in the core markets (US and EU) by adding more products, and scaling recently completed & announced acquisitions.

Also, through its in-house research & development capabilities. Your Company has identified multiple areas for significant value creation and synergies from recent acquisitions and plans to leverage the infrastructure of the acquired businesses to drive penetration and optimize value creation by leveraging its vertically integrated platform.

Your Company is expanding its portfolio mix towards differentiated products with pipeline encompassing oncology, hormones, inhalers and Biosimilars, among other, and an addressable market over US$100 billion (as per IQVIA MAT Mar 2019). In US the acquisition of Sandoz’s dermatology and oral solids businesses, comprising authorized generics and in-licensed products, offer significant synergy and value creation potential for your Company.

In the EU, your Company will continue to expand its portfolio through launches of targeted Day 1 products, oncology range, hormones, niche low injectables and orals. Your Company has a pipeline of over two hundred fifty products under development. Further, your Company sees an opportunity of more than US$5 billion of addressable sales coming off-patent in the near term (2019-20) and more than US$13 billion in the medium term (2021-22). In addition, countries such as Italy, Spain, Portugal and France offer growth potential as the penetration of generics improves. The acquisition of Apotex’s business in five key European countries will allow your Company to further expand its product offering and its position in Eastern Europe.

Your Company will also work on expanding its presence in Growth Markets through the launch of new products especially from its oncology portfolio and will continue its strategy of focusing on tenders for ARV formulations.

The API segment that supplies products to third parties as well as strengthens the business model of Aurobindo by providing vertical integration for the manufacturing of formulations will be scaled up as per market dynamics and business needs.


Aurobindo has a dedicated research team that consists of more than 1,600 scientists and analysts who work on developing a wide range of medications from simple plain-vanilla generics to complex speciality products. The research philosophy of the Company is to provide a broad basket of products in a category or a therapeutic area that the Company forays into. Currently, the Company has seven Research and Development (R&D) centres, of which five are in India and two are in the USA. In FY2018-19, the Company has invested 4.5% of its consolidated revenue i.e. Rs,8,682.6 million in research & development.

The aim of the research team is to develop affordable generic medications and products that would be accessible to all strata of society. Given the ever-rising cost of healthcare worldwide, it is imperative that less expensive, high quality generics alongside branded counterparts become available to patients worldwide.

Oncology and Hormones

Eugia has a diverse portfolio comprising more than seventy five products that are prescribed for oncology, hormones and immuno-suppressant indications. The Company has shortlisted over sixty five generic oncology products for formulations development. These products are prescribed in the treatment of over 25 different indications involving mainly first-line and second-line therapies in cancer patients either in single or in combination with other drugs. The Company has filed 13 ANDAs for Oncology products including four injectable products.

The company has shortlisted ten generic Hormone products for formulations development. These products are prescribed for indications such as Pre-term birth, Birth Control, Amenorrhea and Hypogonadism. The Company has filed nine ANDAs.

A total of 22 ANDAs have been filed as of March 31, 2019.

The development and manufacturing of Oncology & Hormone products require specialized preparations and containment measures. The manufacturing facility is designed to cater to >20% of the global volume demand for those products that are part of Eugia’s portfolio. Eugia has the capability to develop and manufacture 6 different dosage forms.

- Oral solid dosage forms (Tablets, Hard Gelatin Capsules & Soft Gelatin Capsules)

- Injectables (Wet vials, Dry (lyophilized) vials & Pre-filled syringes)

In FY2018-19, the Company has received approval for four products (two oncology and two hormonal products) and completed exhibit batches for twenty three products. The Company has also planned to develop and manufacture oncology and hormone products to cater to the requirements in Europe, Canada, China and other key emerging markets through other subsidiaries.

In FY2019-20, it is estimated that the Company will file 15-18 ANDA’s with USFDA. Registrations are in progress in Europe and other key emerging markets. The Company has commenced its commercial manufacturing operations and is expected to launch more than ten products in the US and EU markets in FY2019-20.

According to IQVIA, spending on cancer therapies and supportive care drugs accounted for US$99.5 billion in developed economies (the USA, 5-EU etc.) and selected emerging markets (Brazil, China, India, Mexico etc.) in 2018. The US is the biggest contributor to this and accounted for 46% of global spending.

The market for oncology therapeutic medicines is estimated to reach US$140-150 billion by 2023 in these selected markets growing at a CAGR of 6-7%. Oncology products are expected to account for approximately 30% of the new launched medicines (~70-90 products) over the next five years. The generic oncology market is estimated at US$20 billion currently and is forecasted to grow at CAGR of 6.7% to reach US$23 billion by 2021, considering loss of patent expiry for few branded drugs and increase in demand for generic medicines.


Aurobindo uses recombinant DNA technology to express and produce Biologics in a living system such as a mammalian cell or a microorganism. Biologics we work with are large, complex proteins and monoclonal antibodies.

Aurobindo has one of the industry leading portfolio of 14 biosimilars, which include five molecules acquired from TL Biopharmaceuticals AG. The pipeline caters to oncology, rheumatology and ophthalmology. In first wave of development, the Company is working on five products - all advancing to different stages of clinical trials in the next two to three quarters. Phase III clinical trials of ophthalmic products is expected to start in this fiscal year, three more products including our lead molecule Bevacizumab, a biosimilar version of Avastin, will be tested in Phase I clinical trials. The combined market size of these four products is in excess of US$ 20 billion.

As this segment is an important growth driver, the Company commissioned a state-of-the-art manufacturing facility of 1,40,000 square feet comprising mammalian cell culture, microbial fermentation, quality control, fill and finish sections. The fill and finish facility can cater to filings product in vials, syringes and cartridges. This fully integrated facility is operational and is generating material for clinical trial requirement. Currently, over 160 people with a strong scientific background in cell biology bioprocess engineering, protein chemistry, regulatory and clinical sciences are employed in Biologics division of the Company.


Dermatology is an area of medicine concerned with the health of the skin and diseases of the hair, nails, and mucous membranes. The skin is the largest organ in the body. It is the first line of defense against bacteria and injury, and often reflects overall health.

The Company is currently working on twenty four products on different segments such as Acne Vulgaris, Inflammatory lesions of Rosacea, Atopic Dermatitis, Hypogonadism, Menopause, Vaginal Atrophy, Osteoarthritis, Herpes, Pruritus and lice infestations. The market size of these products is estimated at US$4.4 billion. The identified products have presence across various dosages including ointment, cream, gel, lotion and solutions in the pipeline.

Of the twenty four products under development, around eighteen products need clinical trials or Bioequivalence (BE) studies.

During FY2018-19, Aurobindo has completed clinical trial for one product and is planning further trails for about close to seven products in FY2019-20.

In FY2018-19, the Company has produced exhibit batches for two products and is planning to execute exhibit batches for another eight to ten products in FY2019-20.

The Company filed three ANDAs in FY2018-19, and is planning to file another 8-10 ANDAs over the next two years.

Transdermal Patches

A Transdermal patch is a medicated adhesive patch that is placed on the skin to deliver a specific dose of medication. They release small amounts of drug through the skin into the blood stream over a long period of time. These patches may include pain relievers, nicotine, hormones, and drugs to treat angina and motion sickness.

Aurobindo has eight transdermal products under development with an addressable global market size of around US$3.3 billion. All these products need either clinical trials or BE studies. The Company has successfully completed pilot BE studies for one product. The Company is likely to file two ANDAs by FY2020-21. The Company is developing transdermal products in North Carolina R&D center. The Company also completed setting up a manufacturing facility for the same.



An inhaler (puffer or pump) is a medical device used for delivering medication into the body via the lungs.

The most common type of inhaler is the pressurized Metered-Dose Inhaler (MDI), that delivers medication by using a propellant spray. Another form of inhaler is a Dry-Powder Inhaler (DPI) which is breath-activated. The medication is released only when you take a deep, fast breath-in through the inhaler.

Respiratory is one of the key therapeutic areas where Aurobindo is strengthening its presence. The Company is working on building a pipeline of metered dose inhalers and dry powder inhalers. Within respiratory products, the Company now has nine inhaler products under development; of which two products are likely to come up for clinical trials during FY2019-20. The market size of products under development is US$13.3 billion.

The Company expects to file first ANDA during FY2019-20. Inhalers will be manufactured at North Carolina facility.


Nasals or nasal sprays are used to deliver medications locally in one’s nasal cavities as substances can be assimilated quickly and directly through the nose. In certain cases, the nasal delivery route is preferred because it provides a good alternative to injection or pills.

Aurobindo has identified seven nasal products for development.

Of which, the company already filed ANDAs for two products.

The total market size of all the seven products is US$1.4 billion. The Company is planning to file three more in ANDAs in FY2019-20. These products are manufactured in Unit X, and the unit has a current monthly capacity to produce 1.4 million units.

Depot Injections

Your Company is currently developing four depot injections that have a combined addressable market size of US$3.6 billion.

One of the products from this segment is likely to have exhibit batches ready in FY2019-20 and clinical trials will start in second half of FY2019-20. The Company plans to file the first product in FY2020-21.


Peptides are short chains of amino acid monomers linked by peptide (amide) bonds. The Company has invested in developing a state-of-the-art peptide development laboratory and has four manufacturing suites for its commercial production. Peptides usually have a long gestation period and take four to five years for development.

Auro Peptides has developed the process for manufacturing twenty peptides. The unit has already filed 6 DMFs with the US regulatory authorities and is planning to file an additional 3-4 DMFs in FY2019-20.

For now, Auro Peptides is supplying material for formulation development and the execution of its validation batches. These peptide APIs are being utilized for the development of three liposomal injectable products and seven injectable products. Of which, two to three injectables will be filed in FY2019-20. The addressable market size of products under development is about US$13.5 billion.


Aurobindo identifies and produces biocatalysts through fermentation processes which are subsequently developed into scalable biocatalytic solutions. This reduces the usage of chemicals within the processes during pharmaceutical manufacturing, saving costs whilst benefiting from this green technology. The high technical base and core competence of Aurobindo has made it easier to initiate the entry into enzyme production.

The Company has a highly qualified dedicated team of over 30 professionals, with an on-going technology development program which has built a library of over 7,000 biocatalysts across 15 classes of enzymes. Utilising our state-of-the-art technology, we have developed several processes and these are being scaled into GMP manufacturing assets. Our new cGMP fermentation manufacturing facility is also coming online this year, and a series of new products are now expected to commence manufacturing soon.


The need for improved public health and medicines to protect infants is fast becoming a global priority. In view of this reality, the Company has focused on development of the Pneumococcal Conjugate Vaccine (PCV). The global market size of the product is US$6.2 billion.

In FY2018-19, the Company has completed Phase I clinical trials and started enrolment for Phase II clinical trials in March 2019, which will be completed by August 2019. Phase III clinical trials are expected to commence in early 2020. The Company has already registered the brand in India under the name ‘Pneuteger 15’.

All the clinical trials are expected to be completed by early 2021 and the Company expects to be ready for taking part in the upcoming government tender during 2021. Aurobindo has set up a new manufacturing unit for the same that has the capacity to manufacture 100 million doses a year.


The Company’s EHS initiatives focus on reducing its impact on the environment, improving the work life of employees and making sure that the highest safety standards for employees, contractors and visitors are met. The Company’s EHS standards are dynamic and evolving with international standards to ensure industry best practices. During the year under review, the Company undertook multiple initiatives to remain at the forefront of this journey.


The Company follows international guidelines on safety. It is working to increase safety standards across all its facilities and processes.

At this end, the Company has made it mandatory for all new projects including capacities, buildings and facilities to have EHS clearance and requires that the guidelines are followed right from the planning stage. After completion of a project, a review of the new facility is conducted to vet its compliance to the standards.

The Company has also started incorporating safety requirements in all its production processes. Its safety guidelines are included in the Batch Production and Control Record (BPCR). Such measures will ensure greater workplace safety and prevent any occurrence of hazardous incidents in the production process.

To maintain a safe working environment, safety pep-talks were initiated before every shift, on hazards in activities and necessary precautions to be taken in case of a mishap. The man-hour spent in safety training increased to 0.65% in FY2018-19 from 0.59% last year.

During the year, Hazard and Operability study (HAZOP) was conducted for eighty five products. Risk analysis was conducted for thirty nine products. Behaviour based safety processes were initiated in Units III, XII and VII.

Several initiatives were taken during the year to improve the overall safety across the boards. These included conducting quantitative risk assessments for bulk solvent storage areas, installing sprinkler systems for an additional layer of safety, conducting ergonomic assessments to assess health risks and initiating product-based risk assessments for formulation products.


The Company is working to ensure that its activities have the least impact on the environment and is also upgrading its plants and treatment systems every year to ensure that it remains a frontrunner in promoting sustainability.

During the year, the Company initiated the augmentation and expansion of wastewater treatment facilities at two major API manufacturing units along with the introduction of MBR technology for enhancement of treatment efficiency.

Its facilities are compliant with the regulations stipulated for wastewater treatment, disposal/reuse, hazardous and other wastes management, emissions control, to name a few. Wastewater and air emissions management systems at API Units are viewed and monitored on-line by the concerned environmental regulatory agencies, apart from periodical inspections to site.

The waste streams have been successfully handled and managed effectively on cradle to grave philosophy and are complying with regulations.

The facilities located in Telangana are compliant with on-line manifest system and tracking for respective waste streams as being implemented by the concerned regulatory agency.

It has also successfully completed the environmental impact assessment process for expansion of Aurobindo Unit XI.


With a view to initiate reporting on sustainability, Aurobindo has added the Sustainability vertical - Sustainability to its EHS structure.

In FY2018-19 the Company received SA 8000 accreditation for two of its formulations manufacturing facilities - Aurobindo Pharma Limited, Unit VII and APL Health Care Limited located at SEZ, Jadcherla, Telangana.

Aurobindo Pharma has initiated Environmental Management System across all its units for effective Environmental Management & as part of this 9 units of the company are already certified for ISO 14001:2015 standard. Other units are under pipeline for ISO 14001:2015 certification which will be completed by end of the year 2019 except for unit XVII & XVIII where commercial production is yet to start.

These efforts have borne fruit as the Company’s Environmental Social Governance (ESG) rating and scorecards as ranked by internationally reputed agencies such as EcoVadis have shown a significant improvement.

The Company has taken up green-belt development in close vicinity of its facilities, in schools and near the water bodies. It has planted about 10000 saplings covering a variety of indigenous plant species and is happy to report that a focussed approach and proper maintenance practices have resulted in 80% of survival rate of the saplings.

Antimicrobial Resistance (AMR)

Aurobindo recognized that AMR is a threat and has taken proactive steps to ensure it is at the forefront of the fight against it.

The Company collaborated with The Access to Medicine Foundation to participate in The Antimicrobial Resistance Benchmark 2018 and will be a part of the forthcoming 2020 AMR Benchmark.

Aurobindo is also a member of the AMR industry alliance that brings together research-based pharmaceutical companies, generics, biotech and diagnostic companies, to drive and measure industry progress to curb antimicrobial resistance.

The AMR Industry Alliance will ensure that signatories collectively deliver on the commitments made in the Declaration (January 2016) and the Roadmap (September 2016) and will measure industry’s progress in the fight against AMR.

During the year, the Company also participated in the initiatives of Government of India on combating AMR and engaged actively with the events organized by Ministry of Environment, Forest and Climate Change.


- Aurobindo has been awarded IP Excellence in INDIA 2018 by Questel Orbit INC, as a part of their Indian IP Awards, 2018. The Indian IP Awards are given to facilitate best professionals across the IP (Intellectual Property) Industry.

- Aurobindo Pharma has bagged award for the category of Best CSR Practices in Responsible Business Awards hosted by World CSR Day.

- Aurobindo Pharma has bagged the ''Outstanding Export Award for FY2017-18'' conducted by Pharmaceutical Export Promotion Council of India (Pharmexcil).

- The Indian Institute of Packing, a national autonomous body under the Ministry of Commerce, Government of India

has awarded the INDIASTAR - 2017 to Aurobindo Pharma Limited for its Sustainable Shelf-ready Display carton.

- The Federation of Telangana and Andhra Pradesh Chamber of Commerce and Industry (FTAPCCI) has felicitated Aurobindo with HR Best Practices Awards-2018 in the category of Large-Scale Industries

- Aurobindo has received ‘IDMA Best API Patents Award 201718’ conducted by Indian Drug Manufacturers association

- Our HR team received a Certificate of Achievement from BML Munjal Awards for attaining the ‘Expert Panel’ evaluation milestone. The certificate accolades the commitment towards investment in ‘Learning & Development’ to achieve Business Excellence

- Aurobindo’s HR team was awarded a certificate of merit in ‘Top 7 Rising Stars of HR Competition’ at CII HR Conclave

- Aurobindo HR team won the HR Frame award, a Video Competition for Young HR Professionals organized by CII Telangana. ‘My Super Heros’ a 2 minute video was displayed to a large and eminent audience, at the CII HR Conclave


As per the provisions of Section 129 of the Companies Act, 2013 read with the Companies (Accounts) Rules 2014, a separate statement containing the salient features of the financial statements of subsidiary companies/associate companies/joint ventures is detailed in Form AOC-1 and is in Annexure-1 to this Report.

During the year, the following are the changes in the subsidiaries of the Company:

Ceased as subsidiaries

Mer Medicamentos, Lda, Aurobindo Pharma (Portugal)

Unipessoal Limitada and Aurovitas, Unipessoal LDA, were ceased as subsidiaries consequent to merger of the same with Generis Farmaceutica S.A w.e.f. 1st April, 2018

New subsidiaries/Joint Ventures

Auro Science Pty Ltd., Australia was incorporated on January 6, 2019 as a wholly owned subsidiary of Aurobindo Pharma USA Inc.

Aurobindo Pharma FZ LLC, UAE was incorporated on January

6, 2019 as a wholly owned subsidiary of Helix Healthcare BV Netherlands

Cura TeQ Biologics GmbH, Switzerland, was incorporated on March 20, 2019 as a wholly owned subsidiary of Helix Healthcare BV Netherlands

Auro Science LLC, USA was incorporated on March 28, 2019 as a wholly owned subsidiary of Aurobindo Pharma USA Inc.

Purple Bell Flower Pty Ltd., South Africa was formed as a joint venture under Aurogen Pharma Pty Ltd., South Africa

Apotex Europep B.V Netehrlands; Apotex Netharlands B.V, Netehrlands; Sameko Farma B.V, Netehrlands; Leidapharm

B.V Netehrlands; Marel B.V Netehrlands; Pharma Dossier B.V Netehrlands: Apotex N.V, Belgium; Apotex Polska SP z o o, Spain Apotex (CR) Spool s.r.o, Check Republic and Apotex Espana SL, Spain became the stepdown subsidiaries of Helix Healthcare BV., Netherlands consequent to acquisition of operations of Apotex Inc., Canada.


Consolidated Financial Statements have been prepared by the Company in accordance with the Indian Accounting Standards (Ind AS) 110 and 111 as specified in the Companies (Indian Accounting Standards) Rules, 2015 and as per the provisions of Companies Act, 2013. The Company has placed separately, the audited accounts of its subsidiaries on its website www., in compliance with the provisions of Section 136 of the Companies Act, 2013. Audited financial statements of the Company''s subsidiaries will be provided to the Members, on request.


On December 31, 2018, Securities and Exchange Board of India amended the Prohibition of Insider Trading Regulations, 2015, prescribing various new requirements with effect from April 1, 2019. In line with the amendments, your Company has adopted an amended Code of Conduct to regulate, monitor and report trading by Designated Persons and their Immediate Relatives under the Securities and Exchange Board of India (Prohibition of Insider Trading) Regulations, 2015. This Code of Conduct also includes code of practices and procedures for fair disclosure of unpublished price sensitive information and has been made available on the Company’s website at https://www.aurobindo. com/investors/corporate-governance/code-of-practices-and-procedures-for-fair-disclosure/


The Board of Directors has adopted the Whistle Blower Policy which is in compliance with Section 177(9) of the Companies Act, 2013 and Regulation 22 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. The Whistle Blower Policy aims for conducting the affairs in a fair and transparent manner by adopting highest standards of professionalism, honesty, integrity and ethical behavior. All permanent employees and whole-time directors of the Company are covered under the Whistle Blower Policy

A mechanism has been established for employees to report their concerns about unethical behavior, actual or suspected fraud or violation of Code of Conduct and Ethics and leak of price sensitive information under the Company’s Code of Conduct formulated for regulating, monitoring and reporting by Insiders under SEBI (Prohibition of Insider Trading) Regulations, 2015, as amended from time to time. It also provides for adequate safeguards against the victimization of employees who avail of the mechanism and allows direct access to the Chairperson of the Audit Committee in exceptional cases. The Whistle Blower Policy is available on the Company''s website: http://www.aurobindo. com/about-us/governance/governance-policies /


Your Company has a policy and framework for employees to report sexual harassment cases at workplace and the said process ensures complete anonymity and confidentiality of information. Your Company has constituted an Internal Complaints Committee in compliance with the Sexual Harassment of Women at Workplace (Prevention, Prohibition and Redressal) Act, 2013 and the Rules there under. The Company has a policy on prevention & prohibition of sexual harassment at workplace. The policy provides for protection against sexual harassment of women at workplace and for the prevention and redressal of such complaints. During the year the Company received one complaint and disposed of the same. The Company has been conducting awareness programme to the employees of the Company, on prevention of sexual harassment.


The Board and Committee meetings are prescheduled and a tentative calendar of the meetings finalized in consultation with the Directors to facilitate them to plan their schedule. However, in case of special and urgent business needs, approval is taken by passing resolutions through circulation. During the year under review, six Board Meetings and five Audit Committee Meetings were convened and held. The details of the meetings including composition of Audit Committee are provided in the Corporate Governance Report. During the year, all the recommendations of the Audit Committee were accepted by the Board.


Key Managerial Personnel

Mr. K. Nithyananda Reddy, Executive Vice Chairman,

Mr. N.Govindarajan, Managing Director, Dr.M.Sivakumaran, Whole-time Director, Mr.M.Madan Mohan Reddy, Whole-time Director, Mr.P.Sarath Chandra Reddy, Whole-time Director,

Mr. Santhanam Subramanian, Chief Financial Officer and Mr. B. Adi Reddy, Company Secretary are Key Managerial Personnel of the Company in accordance with the provisions of Section(s) 2(51), and 203 of the Companies Act, 2013 read with the Companies (Appointment and Remuneration of Managerial Personnel) Rules, 2014. There has been no change in the Key Managerial Personnel during the financial year.

None of the directors of the Company are disqualified under the provisions of the Companies Act, 2013 (‘Act’) or under the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. All Independent Directors have provided confirmations as contemplated under section 149(7) of the Act.


As per the provisions of the Companies Act, 2013, Mr. P.Sarath Chandra Reddy and Dr. M. Sivakumaran will retire at the ensuing annual general meeting and being eligible, seek reappointment. The Board of Directors recommends their re-appointment.

The re-appointment of Mr. P. Sarath Chandra Reddy as Wholetime Director with effect from June 1, 2019 is being proposed at the ensuing Annual General Meeting. The reappointment of Mr. K. Ragunathan, Mrs. Savita Mahajan and Dr. (Mrs) Avnit Bimal Singh as Independent Directors for the second term are also being proposed at the ensuing Annual General Meeting. The Board of directors recommends their re-appointment.


Pursuant to Section 134(3)(c) of the Companies Act, 2013 your Directors confirm that:

a. i n the preparation of the annual accounts, the applicable accounting standards have been followed along with proper explanation relating to material departures, if any;

b. appropriate accounting policies have been selected and applied consistently. Judgement and estimates which are reasonable and prudent have been made so as to give a true and fair view of the state of affairs of your Company as at the end of the financial year and of the profit of your Company for the year;

c. proper and sufficient care has been taken for the maintenance of adequate accounting records in accordance with the provisions of the Companies Act, 2013 for safeguarding the assets of your Company and for preventing and detecting fraud and other irregularities;

d. the annual accounts have been prepared on a going concern basis;

e. proper internal financial controls have been laid down to be followed by your Company and such internal financial controls are adequate and are operating effectively; and

f. proper systems to ensure compliance with the provisions of all applicable laws have been devised, and such systems are adequate and are operating effectively.


The Independent Directors have submitted the declaration of independence stating that they meet the criteria of independence as provided in sub-section (6) of Section 149 of the Companies Act, 2013 as well as clause (b) of sub-regulation (1) of Regulation 16 of the Listing Regulations (including any statutory modification(s) or re-enactment(s) thereof for the time being in force). In terms of Regulation 25(8) of the Listing Regulations, the Independent Directors have confirmed that they are not aware of any circumstance or situation, which exist or may be reasonably anticipated, that could impair or impact their ability to discharge their duties.


The Company recognizes and embraces the importance of a diverse board in its success. The Board has adopted the Board Diversity Policy which sets out the approach to diversity of the Board of Directors. The Board Diversity Policy is available on the Company''s website: governance/governance-policies/.


SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 mandates that the Board shall monitor and review the Board evaluation framework. The Companies Act, 2013 states that a formal annual evaluation needs to be made by the Board of its own performance and that of its committees and individual directors. Schedule IV of the Companies Act, 2013 states that the performance evaluation of independent directors shall be done by the entire Board of Directors, excluding the director being evaluated.

The Annual Performance Evaluation was conducted for all Board Members, for the Board and its Committees for the financial year 2018-19. This evaluation was led by the Nomination and Remuneration / Compensation Committee. The Board evaluation framework has been designed in compliance with the requirements under the Companies Act, 2013 and the Listing Regulations and in accordance with the Guidance Note on Board Evaluation issued by SEBI in January 2017. The Board evaluation was conducted through questionnaire designed with qualitative parameters and feedback based on ratings.

Evaluation of Committees was based on criteria such as adequate independence of each Committee, frequency of meetings and time allocated for discussions at meetings, functioning of Board Committees and effectiveness of its advice/ recommendation to the Board, etc.

Evaluation of Directors was based on criteria such as participation and contribution in Board and Committee meetings, representation of shareholders interest and enhancing shareholders value, experience and expertise to provide feedback and guidance to top management on business strategy, governance, risk and understanding of the organization’s strategy, etc.


The policy of the Company on directors'' appointment and remuneration, including criteria for determining qualifications, positive attributes, independence of a director and other matters are adopted as per the provisions of the Companies Act, 2013. The remuneration paid to the Directors is as per the terms laid out in the nomination and remuneration policy of the Company. The nomination and remuneration policy as adopted by the Board is placed on the Company''s website: about-us/governance/governance-policies/.


Your Company has not transferred any amount to reserves during the year under review.


Loans, guarantees and investments covered under Section 186 of the Companies Act, 2013 form part of the Notes to the financial statements provided in this Annual Report.


All transactions entered with Related Parties for the year under review were on arm’s length basis and in the ordinary course of business. All related party transactions are mentioned in the Notes to the Financial Statements. The Company has developed a framework through Standard Operating Procedures for the purpose of identification and monitoring of such Related Party Transactions. A statement giving details of all Related Party Transactions are placed before the Audit Committee and the Board for review and approval. The policy on Related Party Transactions as approved by the Board of Directors has been uploaded on the website of the Company governance/governance-policies/

The particulars of contracts or arrangements with related parties referred to in sub-section (1) of Section 188 of the Companies Act, 2013 is prepared in Form No. AOC-2 pursuant to clause (h) of subsection (3) of Section 134 of the Act and Rule 8(2) of the Companies (Accounts) Rules, 2014 and is in Annexure-2 to this Report.


As required under Section 134 (3) (a) and Section 92(3) of the Companies Act, 2013 read with Rule 12(1) of the Companies (Management and Administration) Rules, 2014, the extract of Annual Return prepared in Form MGT-9 and is in Annexure-3 to this report. The Annual Return of the Company will be made available on its website


Information with respect to conservation of energy, technology absorption, foreign exchange earnings & outgo pursuant to Section 134(3)(m) of the Act read with Companies (Accounts) Rules, 2014 and is in Annexure-4 to this Report.


Risk Management Committee of the Company consists of the following Directors viz. Mr. M. Sitarama Murty, Mr. N. Govindarajan and Mr. P. Sarath Chandra Reddy. Mr. M. Sitarama Murty is the Chairman of the Committee. The Company has established a separate department to monitor the enterprise risk and for its management. The Committee had formulated a risk management policy for dealing with different kinds of risks which the Company faces in its day-to-day operations. Risk management policy of the Company outlines different kinds of risks and risk mitigating measures to be adopted by the Board.

Risk is an integral part of the Company’s business, and sound risk management is critical to the success of the organization. The Company has adequate internal financial control systems and procedures to combat the risk. The risk management procedure is reviewed by the Audit Committee and Board of Directors on regular basis at the time of review of quarterly financial results of the Company. A report on the risk and their management is enclosed as a separate section forming part of this report.


The statutory auditors'' report is annexed to this report. The notes on financial statements referred to in the Auditors'' Report are self-explanatory and do not call for any further comments. There are no specifications, reservations, adverse remarks on disclosure by the statutory auditors in their report. They have not reported any incident of fraud to the Audit Committee of the Company during the year, under review.

Pursuant to Section 139 (2) of the Companies Act, 2013, read with Companies (Audit and Auditors) Rules, 2014, the Company at its 30th Annual General Meeting (AGM) held on August 31, 2017, had appointed M/s. B S R & Associates LLP, Chartered Accountants as Statutory Auditors for a period of 5 years i.e. up to the conclusion of the 35th AGM to be held in the year 2022. Further, as per Companies (Amendment) Act, 2017 effective from May 07, 2018, the provisions relating to ratification of the appointment of Statutory Auditors at every AGM are not required to be followed.


Ernst & Young LLP are the internal auditors of the Company and to maintain its objectivity and independence, the Internal Auditors report to the Chairman of the Audit Committee. The scope and authority of the Internal Audit function is clearly defined by the Audit Committee of the Board. The Internal Auditors monitor and evaluate the efficacy and adequacy of internal control system of the Company, its compliance with applicable laws/regulations, accounting procedures and policies. Based on the reports of the Internal Auditors, corrective actions were undertaken and thereby strengthened the controls. Significant audit observations and action plans were presented to the Audit Committee of the Board on quarterly basis.


Pursuant to Section 148 of the Companies Act, 2013 read with the Companies (Audit and Auditors) Rules, 2014 and the Companies (Cost Records and Audit) Rules, 2014, the Company is maintaining the cost records as its business is covered under the regulated sector viz. drugs and pharmaceuticals. Audit of the Company''s cost records is not applicable since the Company''s revenues from exports, in foreign exchange, exceed 75% of its total revenues.


The internal financial controls (IFC) framework institutionalized in Aurobindo has been evaluated in-depth for its adequacy and operating effectiveness, wherein the Company has covered financial reporting controls, operational controls, compliance related controls and also Information Technology (IT) controls, comprising IT general controls (ITGC) and application level controls. The ITGC would include controls over IT environment, computer operations, access to programs and data, program development and program changes. The application controls would include transaction processing controls in ERP Oracle system which supports accurate data input, data processing and data output, workflows, reviews and approvals as per the defined authorization levels.

In order to further strengthen the existing IFC framework and to support the growing business, the Company has redefined all the process level controls at activity level which has brought in more clarity and transparency in day-to-day processing of transactions and in addressing any related risks. All the controls so redefined & identified have been properly documented and tested with the help of an independent auditor to ensure their adequacy and effectiveness.

The internal auditors conduct '' Process & control review'' on a quarterly basis as per the defined scope and submit the audit findings along with management comments and action taken reports to Audit Committee for its review.

The IFC framework at Aurobindo ensures the following:

- Establishment of policies & procedures, assignment of responsibility, delegation of authority, segregation of duties to provide a basis for accountability and controls;

- Physical existence and ownership of assets at a specified date;

- Enabling proactive anti-fraud controls and a risk management framework to mitigate fraud risks to the Company;

- Recording of all transactions occurred during a specific period. Accounting of assets, liability, and revenue and expense components at appropriate amounts;

- Preparation of financial information as per the timelines defined by the relevant authorities.

These controls cover the policies and procedures adopted by the Company for ensuring the orderly and efficient conduct of its business including adherence to the Company’s policies, safeguarding of its assets of the Company, prevention and detection of its frauds and errors, accuracy and completeness of accounting records and timely preparation of reliable financial information. The Company has an internal control system, commensurate with the size, scale and complexity of its operation


Pursuant to the provisions of Section 204 of the Companies Act, 2013 and Rule 9 of the Companies (Appointment and Remuneration of Managerial Personnel) Rules, 2014, the Company has appointed Mr.A.Mohan Rami Reddy, a Company Secretary in Practice to undertake the secretarial audit of the Company for the financial year 2018-19. The Secretarial Audit Report issued in form MR-3 is and in Annexure-5 to this Report.

There are no qualifications, reservations or adverse remarks in the Secretarial Audit Report. Also, pursuant to Regulation 24A of the SEBI (Listing Regulations), 2015, the Company has obtained Annual Secretarial Compliance Report from a Practicing Company Secretary and submitted the same to stock exchanges where the shares of the Company are listed.


In compliance with Section 135 of the CA 2013 read with the Companies (Corporate Social Responsibility Policy) Rules 2014, the Company has established the Corporate Social Responsibility Committee (CSR Committee). Your Company is striving to help create a healthy, improved life of people in its neighborhood. Broadly, the initiatives are to execute on the stated CSR policy of ''give back to the society'' and make an impact on the lives of people.

The activities undertaken during 2018-19 can be summarized under the following heads:

- Promoting education;

- Supporting preventive health care;

- Eradicating hunger, poverty & malnutrition;

- Making available safe drinking water;

- Encouraging environment sustainability;

- Sustaining ecological balance & conservation of natural resources;

- Developing rural sports; and

- Setting up old age homes, etc

A detailed account of the CSR activities forms part of the annual report and placed on the Company''s website at: Report on Corporate Social Responsibility as per Rule 8 of the Companies (Corporate Social Responsibility Policy) Rules, 2014 is provided as Annexure-6 to this Report.


The statement of particulars of appointment and remuneration of managerial personnel as required under Section 197(12) of the Companies Act, 2013 read with Rule 5 of the Companies (Appointment and Remuneration of Managerial Personnel) Rules, 2014 and is in Annexure-7 to this Report.

The statement containing particulars of employees pursuant to Section 197(12) of the Companies Act, 2013 read with Rule 5(2) of the Companies (Appointment and Remuneration of Managerial Personnel) Rules, 2014 is open for inspection at the Registered office of the Company during business hours on all working days of the Company up to the date of the ensuing Annual General Meeting. Any shareholder interested in obtaining such details may write to the Company Secretary of the Company.

Affirmation that the remuneration is as per the remuneration policy of the Company.

In compliance with the provisions of the Companies Act, 2013 and SEBI Listing Regulations, the Board, on the recommendation of the Nomination and Remuneration/Compensation Committee approved the Policy for Selection, Appointment and of Directors, KMPs and Senior Management persons. The said Policy provides a framework to ensure that suitable and efficient succession plans are in place for appointment of Directors on the Board and other management members. The Policy also provides for selection and remuneration criteria for appointment of Directors and senior management persons.

The Company affirms that the remuneration is as per the remuneration policy of the Company.


All properties and insurable interests of the Company including building, plant and machinery and stocks have been fully insured. The Company has also taken D & O Insurance Policy covering Company''s Directors and officers.


There are no material changes and commitments in the business operations of the Company from the financial year ended March 31, 2019 to the date of signing of the Director''s Report.


A separate section on Corporate Governance standards followed by your Company, as stipulated under Schedule V (C) of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 is enclosed as a separate section forming part of this report.

The certificate of the Practicing Company Secretary Mr. S. Chidambaram with regard to compliance of conditions of corporate governance as stipulated under Schedule V(E) of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 is annexed to the Corporate Governance Report.


Management Discussion and Analysis Report for the year under review as stipulated under SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 is presented in a separate section forming part of this report.


Your Company has not accepted any deposits from the public within the purview of Chapter V of the Companies Act, 2013.


Industrial relations at all units of the Company have been harmonious and cordial. The employees are motivated and have shown initiative in improving the Company''s performance.


The dividends that remained unpaid/unclaimed for a period of seven years, have been transferred on due dates by the Company to the Investor Education and Protection Fund (IEPF) established by the Central Government.

Section 124 of the Companies Act, 2013 read with the Investor Education and Protection Fund Authority (Accounting, Audit, Transfer and Refund) Rules, 2016 (''the Rules'') mandates that companies shall apart from transfer of dividend that has remained unclaimed for a period of seven years from the unpaid dividend account to the Investor Education and Protection Fund (IEPF), also transfer the corresponding shares with respect to the dividend, which has not been paid or claimed for seven consecutive years or more to IEPF. Accordingly, the dividends that remain unclaimed for seven years and also the corresponding shares have been transferred to IEPF account on due dates.

The details of amount of unclaimed unpaid dividend and corresponding shares ''transferred to IEPF during the financial year 2018-19 have been provided in the AGM Notice.


During the financial year under review, there has been no change in the Authorized Share Capital of the Company. However, the paid up equity share capital of the Company increased by Rs,8,000 during the year consequent to the allotment of 8,000 equity shares of Rs,1 each on exercise of stock options under the Employee Stock Option Plan-2006 (ESOP 2006) of the Company. The paid up share capital of the Company as on March 31, 2019 was Rs,585,915,609 divided into 585,915,609 equity shares of Rs,1 each. The Company has not issued any debentures, bonds or any non-convertible securities during the financial year under review.


The Members at the Annual General Meeting of the Company held on September 18, 2006 approved formulation of Employee Stock Option Scheme- 2006 (ESOP 2006) for the eligible employees and Directors of the Company and its subsidiaries. Details of the stock options as on March 31, 2019 is provided on the Company''s website: governance/governance-policies/. The details of the employee stock options also form part of the notes to accounts of the financial statements in this Annual Report.


A detailed Business Responsibility Report in terms of the provisions of Regulation 34 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 is available as a separate section in this Annual Report.


There were no significant material orders passed by the Regulators or Courts or Tribunals that would impact the going concern status of the Company and its operations in future.

The Company has complied with Secretarial Standards issued by the Institute of Company Secretaries of India.

Acquisitions / Disinvestment/ demerger/merger

A. Acquisitions


The wholly owned step-down subsidiary of the Company, Agile Pharma B.V. (Netherlands) has entered into an agreement in July

2018 to acquire commercial operations and certain supporting infrastructure in five European countries viz. the Netherlands, Belgium, Spain, Poland and Czech Republic from Apotex International Inc. a Canadian pharmaceutical company engaged in the manufacture and marketing of pharmaceutical products. The Acquisition of Apotex’ businesses in Poland, Czech Republic, the Netherlands, Spain and Belgium was completed in February, 2019.


The wholly owned subsidiary of the Company, Aurobindo Pharma USA Inc., USA, has entered into an agreement to acquire commercial operations and three manufacturing facilities in USA from Sandoz Inc., USA, a Novartis Division.

The acquisition includes in-line portfolio of dermatology and oral solids, authorised generics and in-licensing products, Branded dermatology products, 3 manufacturing facilities at, Hicksville -NY (Derma), Melville - NY(Derma), Wilson- NC (OSD), and 100% shareholding in Eon Labs Inc, a wholly owned subsidiary of Sandoz.

This is a carved out business of Sandoz in US and the product portfolio consists of Dermatology, CNS, Alimentary Tract/ Metabolic, Women’s Health, Anti-infectives, Systemic Hormones and others along with three manufacturing facilities situated in Hicksville and Melville in New York and Wilson in North Carolina. The acquisition is in progress.


The wholly owned subsidiary of the Company, Aurobindo Pharma USA Inc., USA, has in November 2018 acquired a product under development and related assets from ‘Advent Pharmaceuticals Pty Ltd., Australia, through AuroScience Pty Limited, Melbourne, a 100% subsidiary of Aurobindo Pharma USA Inc., USA.

- Acquisition provides an opportunity to acquire assets that would be used for specialty generics business.

- Acquisition will lead to enhancement of R &D capabilities in complex specialty generics


The wholly owned subsidiary of the Company, Helix Healthcare

B.V, Netherlands, has entered into an agreement with Shandong Luoxin Pharmaceutical Group Stock Co., Ltd, China (Luoxin) to establish a Joint Venture Company in China with manufacturing facilities to manufacture nebuliser inhaler and other products for China, US and EU markets. However, for Europe markets, the new Joint Venture Company will establish its fully owned subsidiary(ies) in any of the European countries.


Acrotech Biopharma L.L.C., a wholly owned subsidiary of Aurobindo Pharma USA Inc., USA, which in turn is a wholly owned subsidiary of the Company, has entered into a definitive agreement to acquire seven marketed oncology injectable products, intellectual property and commercial infrastructure from Spectrum Pharmaceuticals Inc., (NASDAQ:SPPI), a US based, global branded oncology company. Spectrum has as part of its major strategic shift to focus on novel oncology drug development and commercialization of its two late-stage pipeline products, carved out its commercial business inclusive of seven marketed oncology injectable products, intellectual property and commercial infrastructure for sale. The acquisition has been completed on March 1, 2019.


The Company has made an investment of Rs,150 million in Synergy Remedies Private Limited (Synergy), a Tirupathi based pharma company and acquired 19.9% holding in the said company. The objective of this acquisition was to ensure assured supplies of some of the APIs and intermediates.

B. Merger

Merger of wholly owned Subsidiaries

On May 28, 2019 the Board of Directors had accorded its approval for the draft scheme for merger of Company''s 5 (Five) Wholly Owned Subsidiaries (i.e. APL Research Centre Limited, Aurozymes Limited, Curepro Parenterals Limited, Hyacinths Pharma Private Limited and APL Healthcare Limited) and 1 (one) step-down wholly owned subsidiary (i.e. Silicon Life Sciences

Private Limited) with the Company. No shares of the Company will be issued as consideration for the said amalgamation and the shares held by the Company in its wholly owned subsidiaries and step-down wholly owned subsidiary shall stand cancelled. The Scheme would be subject to the requisite statutory/ regulatory approvals including the approval of the National Company Law Tribunal (Hyderabad Bench).


The Company has obtained credit rating from India Ratings & Research Private Limited and it has assigned “IND AA ’’/ “INDA1 ” on Rating Watch Positive for Company’s fund based working capital facilities and “IND A1 ” on Rating Watch Positive for Company’s non-fund based working capital limits vide their letter dated September 17, 2018.


Your Directors are grateful to for the invaluable contribution made by the employees and are encouraged by the support of the customers, business associates, banks and government agencies. The Directors deeply appreciate their faith in the Company and thankful to them. The Board shall always strive to meet the expectations of all the stakeholders.

For and on behalf of the Board

K. Ragunathan

Place: Hyderabad Chairman

Date: 28 May 2019 DIN: 00523576

Director’s Report