FIPB approved 8 FDI brownfield proposals in pharma sector

UR Associates has come out with its report on pharma space. According to research firm FIPB approved 8 FDI brownfield proposals.

The Foreign Investment Promotion Board (FIPB) in its meeting held on August 24, 2012 approved 21 FDI proposals worth Rs 24.10 billion which includes 8 FDI pharma proposals. The 8 approvals were based on some conditions including:

• The quantitative level of NLEM (National List of Essential Medicines) drugs produced annually at the time of induction of foreign investment will be maintained at that level (defined as the highest annual production level of NLEM drugs in quantitative terms, in any of the three years proceeding) for the next 5 years
• The highest level of R&D expenses incurred in the 3 preceding years by the investee company will be maintained in value terms annually over the next 5 years post induction of FDI
• The administrative ministries concerned and the FIPB secretariat should be provided complete information pertaining to the transfer of technology, if any, along with induction of foreign investment into the investee company

The 8 pharma proposals approved are:

• M/s Ordain Health Care, Chennai – FDI of Rs 588.5 million
• M/s Sutures India, Bangalore – FDI of Rs 2,000 million
• M/s Arch Pharmalabs, Mumbai – FDI of Rs 3,723.6 million
• M/s B Braun Singapore – Acquisition of shares of the company of value Rs 2,484 million
• M/s Stellence Pharmscience, Bangalore – Induction of foreign equity (equity shares and compulsory convertible preference shares) of Rs 1,000 million
• M/s Pfizer, Mumbai – Induction of foreign equity of Rs 8,000 million
• M/s Vyome Biosciences Private, Delhi - Induction of foreign equity of Rs 125 million
• M/s Zim Laboratories, Nagpur – Induction of foreign equity of Rs 504.4 million

Ranbaxy Laboratories to set up second plant in Malaysia at $40 million investment:
Ranbaxy Laboratories received approval from Malaysian authorities to set up its second manufacturing plant in the country at an investment of USD 40 million (around Rs 2.20 billion). Ranbaxy Malaysia Sdn Bhd, a subsidiary of Ranbaxy Laboratories, received approval for setting up a greenfield manufacturing facility in Malaysia as an EPP (Entry Point Project). The new facility will manufacture dosage forms, including tablets and capsules, primarily in the cardiovascular, anti-diabetic, anti-infective and gastrointestinal segments. Strides Arcolab announces US FDA approval of its Polish Sterile Injectables Facility:
Agila Specialties, injectables unit of Strides Arcolab announced that it has received US FDA approval for its ‘Polish Sterile facility’. This state-of-the-art facility located in Warsaw, Poland, manufactures vials, ampoules, pre-filled syringes and lyophilized injections. With this approval all eight global sterile injectable sites of Agila are now approved by the US FDA and EU authorities and places Agila amongst the largest global capacities for sterile injectables. Shipments from the Polish facility will commence within Q4’ 2012 and will run in full capacity by Q1’ 2013, as product transfers have already commenced. Glenmark arm begins clinical trial phase-II of GBR 500 molecule:
Glenmark Pharmaceuticals entered the phase II clinical trials for its new drug molecule aimed at treating ulcerative colitis. The company’s subsidiary Glenmark Pharmaceuticals SA will conduct trials at multiple clinical sites in North America and Europe to investigate the efficacy and safety of the new molecule GBR 500, Glenmark Pharmaceuticals said in a statement. This Phase II clinical trial is part of a global collaboration between Glenmark and Sanofi to investigate GBR 500 for the treatment of chronic inflammatory disorders, the company said. Sanofi has been licensed the rights to all therapeutic indications and is conducting the clinical development programme including this trial, it added. Cadila Pharma to enter Rajasthan with bulk drug facility:
Cadila Pharmaceuticals has acquired land in Rajasthan for setting up a bulk drug facility, its second Indian facility outside Gujarat. The company will pump in Rs 1 billion initially for an active pharmaceutical ingredient ( API) unit that will come up near Udaipur over 30 acres. US Court rules against Lupin on its oral contraceptive drug:
A US court has ruled that the patent held by Johnson & Johnson's on oral contraceptive drug Ortho Tri-Cyclen Lo is valid. The ruling will delay Lupin's launch of the generic version in the US, which has a market of $450 million annually. Analysts said Lupin might launch the generic version of the contraceptive in 2016, while other generic companies that have settled with Johnson & Johnson, may launch the drug in December 2015. Ortho Tri-Cyclen Lo would have been one of Lupin's biggest opportunities. Lupin had received the final approval from US Food and Drug Administration (FDA) in July 2012 for multiple strengths of the tablets. Disclaimer: The views and investment tips expressed by investment experts/broking houses/rating agencies on moneycontrol.com are their own, and not that of the website or its management. Moneycontrol.com advises users to check with certified experts before taking any investment decisions. To read the full report click on the attachment

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