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  • US FDA concludes inspection at Lupin's Goa facility with seven observations Sep 19, 2021 07:48 PM IST

    US FDA concludes inspection at Lupin's Goa facility with seven observations

    The observations made by the US FDA assume significance as the Goa-based plant of Lupin had earlier received a warning letter from the American regulatory body.

  • Drug makers Granules India, Jubilant Cadista recall products in US market Sep 12, 2021 09:11 PM IST

    Drug makers Granules India, Jubilant Cadista recall products in US market

    As per the latest Enforcement Report by US Food and Drug Administration (USFDA), the US-based unit of Granules India is recalling over 1.14 crore Naproxen Sodium tablets, a non-steroidal anti-inflammatory drug used to treat pain, menstrual cramps, inflammatory diseases such as rheumatoid arthritis, gout and fever.

  • COVID-19 Vaccine | We respect FDA's decision, says NITI Aayog's VK Paul on US rejecting EUA for Covaxin Jun 11, 2021 05:39 PM IST

    COVID-19 Vaccine | We respect FDA's decision, says NITI Aayog's VK Paul on US rejecting EUA for Covaxin

    "All of these are scientific considerations & keeping those in mind, the nuancing might be different, especially in those countries where science is strong. Our manufacturing is strong. They have decided this, we respect it", he added.

  • Moderna’s COVID vaccine: What the USFDA briefing document says about its safety, efficacy, Asian participants Dec 17, 2020 08:04 PM IST

    Moderna’s COVID vaccine: What the USFDA briefing document says about its safety, efficacy, Asian participants

    The Phase-3 trial for Moderna’s vaccine involved 30,400 participants. The vaccine was administered in two doses, 28 days apart, in adults 18 years of age and older. Moneycontrol has gleaned some key points from the data presented in the document. Read on.

  • COVID Vaccine: The opportunities for investors - Part I Dec 11, 2020 08:32 AM IST

    COVID Vaccine: The opportunities for investors - Part I

    Vaccine rollout will throw up opportunities not just for the domestic pharmaceutical and healthcare industry but also the logistics value chain, right from vaccine production, delivery, storage and then the actual immunisation

  • IPCA Labs guidance should move investor focus beyond HCQS, accumulate Jul 06, 2020 09:54 AM IST

    IPCA Labs guidance should move investor focus beyond HCQS, accumulate

    There is much more to IPCA Labs than the HCQS opportunity. Its FY21 guidance reflects that.

  • Will 2020 be the year of the pharma sector? Jan 13, 2020 09:00 AM IST

    Will 2020 be the year of the pharma sector?

    The pharma index valuation is trading at a discount to the broad index for the first time in five years.

  • Lupin and peers run into US FDA headwinds again Mar 18, 2019 04:59 PM IST

    Lupin and peers run into US FDA headwinds again

    Lupin’s shares fell after an FDA inspection led to its US unit being issued an adverse warning. Other pharma companies too have tripped on inspections, raising fears that compliance issues are very much alive for the industry

  • Comment | US FDA to get a new chief, watch for side effects on pharma shares Mar 07, 2019 08:07 AM IST

    Comment | US FDA to get a new chief, watch for side effects on pharma shares

    The US FDA has been driving generic drug approvals under its current commissioner. His resignation raises a question mark on whether life could change for Indian pharmaceutical companies

  • 100-Word Take | Dr Reddy's: Slipping on familiar ground Feb 15, 2019 04:10 PM IST

    100-Word Take | Dr Reddy's: Slipping on familiar ground

    Dr Reddy’s investors baulked after news that an inspection by the US FDA found four repeat observations.

  • In crackdown, US FDA seeks details on new electronic cigarettes Oct 13, 2018 08:10 AM IST

    In crackdown, US FDA seeks details on new electronic cigarettes

    An FDA rule banned the sale of new e-cigarette products after August 2016 without regulatory approval

  • US FDA approves first artificial iris May 31, 2018 10:48 AM IST

    US FDA approves first artificial iris

    "Today's approval of the first artificial iris provides a novel method to treat iris defects that reduces sensitivity to bright light and glare. It also improves the cosmetic appearance of the eye in patients with aniridia." he said.

  • US FDA issues Form 483 for Sun Pharma's Halol facility in Gujarat with 3 observations Feb 23, 2018 03:18 PM IST

    US FDA issues Form 483 for Sun Pharma's Halol facility in Gujarat with 3 observations

    The US FDA conducted Good Manufacturing Practices (GMP) inspection of Sun Pharma's Halol facility from February 12 - 23.

  • US FDA makes 3 observations after inspecting Dr Reddy's plant in UK Sep 16, 2017 10:05 AM IST

    US FDA makes 3 observations after inspecting Dr Reddy's plant in UK

    The audit of API Mirfield plant in the UK by the US Food and Drug Administration (FDA) was completed on Friday, Dr Reddy's said in a regulatory filing to stock exchanges.

  • Glenmark gets USFDA approval for Rythmol SR generic Sep 11, 2017 10:55 AM IST

    Glenmark gets USFDA approval for Rythmol SR generic

    "Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (US FDA) for Propafenone Hydrochloride extended-release capsules USP, 225 mg, 325 mg, and 425 mg," Glenmark Pharmaceuticals said in a BSE filing.

  • Analysts consensus is bearish on pharma stocks – should one buy? Aug 14, 2017 07:41 PM IST

    Analysts consensus is bearish on pharma stocks – should one buy?

    All generic pharmaceutical companies across the world and those involved in the distribution of generic drugs in the USA have seen their market value eroding sharply.

  • Glenmark Pharma gets USFDA approval for skin cream generic Jul 25, 2017 12:11 PM IST

    Glenmark Pharma gets USFDA approval for skin cream generic

    "Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (US FDA) for Desonide Cream, 0.05 per cent, the generic version of Desonide Cream, 0.05 per cent of Perrigo New York Inc," Glenmark Pharmaceuticals said in a BSE filing.

  • US FDA policy: New Steps Jun 28, 2017 02:46 PM IST

    US FDA policy: New Steps

    The pharmaceuticals stocks are buzzing on the news that the US Food and Drug Administration (US FDA) has announced two new steps to facilitate generic competition.

  • US FDA issues 5 observations for Lupin's Pithampur Unit 3 Jun 22, 2017 11:15 AM IST

    US FDA issues 5 observations for Lupin's Pithampur Unit 3

    The US Food and Drug Administration (US FDA) issues 5 observations for Lupin's Pithampur Unit 3. In an interview to CNBC-TV18, Amey Chalke, Research Analyst at HDFC Securities shared his readings and outlook on the same.

  • US FDA issued 3 observations to Strides Shasun's Bangalore unit Jun 06, 2017 08:11 AM IST

    US FDA issued 3 observations to Strides Shasun's Bangalore unit

    Strides Shasun's Bangalore unit had received three observations in the month of May. The stock would be in focus because the form 483 has become public and Cadila Healthcare will be in focus because the Baddi unit, which is an important unit in terms of US market, has received an establishment inspection report (EIR) from the United States Food and Drug Administration (USFDA). CNBC-TV18’s Ekta BAtra has more details

  • 5 reasons why pharma stocks could still come under pressure May 25, 2017 04:34 PM IST

    5 reasons why pharma stocks could still come under pressure

    The recent set of results highlights the ills of the sector. Pharmaceutical companies are having a tough time with the US authorities pulling them up regularly for irregularities at one end, while on the other hand the companies are taking a hit on the revenue front at the international and domestic front.

  • Observations for Lupin's Indore unit are largely procedural: PL's Surajit Pal May 25, 2017 10:18 AM IST

    Observations for Lupin's Indore unit are largely procedural: PL's Surajit Pal

    After weak earnings, more bad news for Lupin as the US FDA has issued over six observations for the company's Indore plant. After weak earnings, more bad news for Lupin as the US Food and Drug Administration (US FDA) has issued over six observations for the company's Indore plant.

  • US FDA accepts application for psoriasis drug: Sun Pharma May 24, 2017 11:16 AM IST

    US FDA accepts application for psoriasis drug: Sun Pharma

    "The FDA filing acceptance follows the acceptance of the regulatory filing of tildrakizumab by the European Medicines Agency (EMA) in March 2017. Tildrakizumab is an investigational IL-23p19 inhibitor being evaluated for the treatment of moderate-to-severe plaque psoriasis," Sun Pharma said in a regulatory filing.

  • CNBC-TV18 accesses Form 483 received by DRL's Hyderabad unit May 05, 2017 08:25 AM IST

    CNBC-TV18 accesses Form 483 received by DRL's Hyderabad unit

    Dr Reddy's Laboratories will also be on the radar today. United States Food and Drug Administration (USFDA) has issued Form 483 to DRL’s Hyderabad unit, Bachupally on April 28, 2017. CNBC-TV18 has access to the form 483 it received. Watch Ekta Batra of CNBC-TV18 taking us through the details of how severe are the observations.

  • SeQuent's Vizag plant gets EIR from USFDA May 03, 2017 01:41 PM IST

    SeQuent's Vizag plant gets EIR from USFDA

    SeQuent Scientific has received an establishment inspection report (EIR) from the United States Food and Drug Administration (USFDA) for their animal active pharmaceutical ingredient (API) manufacturing plant at Visakhapatnam. In an interview to CNBC-TV18, Manish Gupta, CEO of the company spoke about the latest happenings in his company and sector.

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