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<ul><li>Pharma company stocks is the only sector gaining in the weak market on Wednesday on optimism to sell anti-covid drugs approved by the drug regulator.</li><li>The pharma regulator gave approval to sell <keyword id="10880838" type="General" weightage="20" keywordseo="molnupiravir" source="Orion">Molnupiravir</keyword> drug, which is an anti-COVID pill, for emergency use in the country.</li><li><keyword id="44642" type="General" weightage="20" keywordseo="sun-pharma" source="Orion">Sun Pharma</keyword>, <keyword id="6357157" type="General" weightage="20" keywordseo="cipla" source="Orion">Cipla</keyword>, Torrent Pharma and <keyword id="4569824" type="General" weightage="20" keywordseo="strides-pharma" source="Orion">Strides Pharma</keyword> have already announced plans to launch their version of this pill soon amid rising spread of Omicron in the country.</li></ul>Pharmaceutical company stocks were the top gainers in a weak market on December 29 as the segment cheered pharma regulator’s — Drugs Controller General of India (DCGI) — approval of anti-covid pill for emergency use in the country. The move comes amid rising spread of Omicron cases in the country. Indian companies will manufacture a generic version of Merck's anti-COVID pill Molnupiravir in India. Molnupiravir is an antiviral medication that is used to treat COVID-19 in those infected. The drug was developed by US-based firms Merck and Ridgeback Biotherapeutics. The development has brought some optimism for pharma stocks that have been underperforming the market for more than a year. <table style="border-width: initial; border-style: none;"></colgroup><tbody><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Top performing pharma stocks on December 29 </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">% of change </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">% returns in 2021 </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Laurus Labs </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">2.38% </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">53% </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Dr Reddy’s Laboratories </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">1.61% </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">-8% </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Sun Pharmaceuticals </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">1.58% </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">38% </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Lupin </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">1.41% </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">-7% </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Alembic Pharmaceuticals </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">1.13% </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">-22% </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Divi’s Laboratories </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">1.67% </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">19% </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Cipla </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">1.08% </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">14% </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Glenmark Pharmaceuticals </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">1.07% </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">3% </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Natco Pharma </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">1% </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">-7% </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Biocon </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">0.97% </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">-22% </td></tr></tbody></table> While Indian companies are manufacturing a generic version from US-based pill, they will market the pill under their respective brands and sell them in pharmacies and COVID-19 treatment centres. <table style="border-width: initial; border-style: none; table-layout: fixed; width: 468pt;"></colgroup><tbody><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Companies </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Anti-COVID pill </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Sun Pharmaceuticals </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Molxvir </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Torrent Pharmaceuticals </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Molnutor </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Cipla </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Cipmolnu </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Strides Pharma Science </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Stripiravir </td></tr></tbody></table>Earlier this year, US-based pharma company Merck had signed non-exclusive voluntary licensing agreements with over eight Indian companies to manufacture and supply generic versions of Molnupiravir in over 100 low and middle-income countries (LMICs), including India. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/stock-market/news/the-ipo-excitement-may-be-softer-in-2022-but-that-can-be-a-good-thing-for-investors/articleshow/88557624.cms">The IPO excitement may be softer in 2022 but that can be a good thing for investors</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/business/startups/news/india-is-home-to-81-unicorns-now-as-mamaearth-globalbees-make-it-to-the-list/articleshow/88558418.cms">India is home to 81 unicorns now as Mamaearth, Globalbees make it to the list</a>

Sun Pharma, Dr Reddy’s Lab, Divi’s Lab and other pharma stocks rally on regulator’s nod to make anti-COVID pill

The government has approved FDI worth around Rs. 4,000 Crores for four pharma and medical devices firms. 
 
The accepted list includes Torrent Pharmaceuticals and Biocon's Syngene. However, Strides Arcolab was not allowed to issue shares to non-resident and resident equity shareholders of Shasun Pharmaceuticals. Three other drug companies’ applications have been delayed. 
 
The government’s decision to allow Torrent Pharmaceuticals' Rs. 3,000 Crores proposal for increasing FII limit to 35% from 13.09% was the biggest today. Syngene's proposal to raise FDI of about Rs. 930 Crores by raising the foreign investment to 44% from the current 10% was the second biggest in the pharmacy sector today. 
 
Others given approval are Stericat Gut Strings Pvt Ltd for FDI of Rs 43.52 Crores as it wants to sell 77.5% of its shares to Groupe Peters Surgical LLC 
 
Ordain Health Care Global Pvt Ltd was also allowed FDI of Rs. 23.34 Crore to buy assets from Alkems Fertica. 
 
The list whose proposals were delayed includes Celon Laboratories, Shantha Biotechnics and Sparsha Pharma International. 
 
(Image credit: Indiatimes)

Whopping Rs. 4,000 Crores FDI boost for Indian Pharma

<ul><li>A US court has ordered generic drug makers to stop selling a copy of Gilenya in US.</li><li>The annual sales of Gilenya, a drug used to treat multiple sclerosis, was about $3.3 billion in 2018.</li><li>The judge pegged the cumulative loss of opportunity on generic drug makers at $50 million.</li></ul> A US court has ordered generic drug makers including Mylan, Dr Reddy's Laboratories, Aurobindo Pharma, and Torrent Pharma to stop selling a copy of Gilenya, for which Novartis holds the patent. The annual sales of Gilenya, a drug used to treat multiple sclerosis, was about $3.3 billion in 2018 and the judge pegged the cumulative loss of opportunity on generic drug makers at $50 million. Novartis has sought to extend its patent on Gilenya beyond 2027, and the deadline to appeal for the extension ends this year. The patent case is still under trial. Double blow The court verdict has come a day after an Indian broking house, India Infoline (IIFL) downgraded Dr Reddy's by a notch. "The company’s market share uptake in Suboxone has been slow, and the key product filings of Nuvaring and Copaxone have also seen some delays," the report said. It has been a double whammy for Aurobindo Pharma too. The US Food and Drug Administration (USFDA) has issued a warning letter for one of the company's unit in Srikakulam in Andhra Pradesh. The unit, which manufactures active pharmaceutical ingredients, was inspected by the American drug regulator in February 2019 after the 'sartan' recall. "Our analysis of 34 WLs and interactions with the company suggest that the facility will be allowed to continue supplying existing molecules. However, future approvals will be withheld until the issues are resolved. There are 12 ANDAs (generic drug applications), including one injectable, pending from Unit 11, of which seven approvals were expected in FY20 and five in FY21. While a majority of these filings are „me too‟ products, there are a few that represent an $10mn+ opportunity annually," a report from SBI Cap Securities said, adding that if the warning escalated to a import ban into the US from the said facility, it could lead to 15% to 20% fall in earnings. SEE ALSO: <a href="https://www.businessinsider.in/abbvies-63-billion-mega-deal-for-botox-maker-allergan-is-the-pharma-industrys-latest-bet-that-bigger-is-better-but-the-deal-is-already-facing-big-questions-/articleshow/69945829.cms" data-type="tilCustomLink" target="_blank">AbbVie's $63 billion mega-deal for Botox-maker Allergan is the pharma industry's latest bet that bigger is better. But the deal is already facing big questions.</a> <a href="https://www.businessinsider.in/donald-trump-on-generic-drugs-indian-pharma-and-katherine-ebans-new-book-with-dinesh-thakur/articleshow/69407566.cms" data-type="tilCustomLink" target="_blank">The man who brought Ranbaxy to its knees is pushing for ‘Made in India’ tag on drugs sold in US</a> <a href="https://www.businessinsider.in/us-generic-drugs-risk-rises-for-indian-pharma-after-new-book-launch/articleshow/69332570.cms?utm_source=contentofinterest&amp;utm_medium=text&amp;utm_campaign=cppst" data-type="tilCustomLink" target="_blank">One chart from a big pharma CEO reveals how drug pricing in the US really works</a>

Mylan, Dr Reddy's, Aurobindo, and Torrent Pharma can't sell generic Gilenya that is patented by Novartis

New Delhi, Nov 24 () The American health regulator has pulled up Torrent Pharmaceuticals' US-based subsidiary for violations of good manufacturing practices, including lack of properly designed equipment and packing material.
 In a warning letter issued to Torrent Pharma Inc's CEO Sanjay Gupta, the US Food and Drug Administration (USFDA) said its inspectors found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals at the company's Levittown (Pennsylvania) based manufacturing facility.
 The USFDA inspected the plant from March 11 to April 9 this year.
 "Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance," the USFDA noted.
 The plant's water system was not adequately designed, controlled, maintained, and monitored to ensure it consistently produced water that met specifications and appropriate microbial limits, it added.
 "An investigation identified your water system as the source of the contamination. Subsequent sampling of your water system revealed an adverse pattern of B. cepacia contamination in your pretreatment and downstream distribution system," the health regulator noted.
 Elaborating, USFDA said that pharmaceutical water must be suitable for its intended use and routinely tested to ensure ongoing conformance with appropriate microbiological attributes.
 "Systems that produce water for manufacturing and cleaning are critical determinants of the quality and safety of your drug products. Your firm produced drug products such as rectal suppositories and oral solutions with this inadequate water system," it said.
 Besides, the company failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed, USFDA added.
 "You lacked an adequate investigation into failing microbiological results from your water system," it noted in its letter dated October 28.
 The US health regulator did not approve of the resolutions brought in by the drug maker at the facility, terming the steps as inadequate.
 "Based upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant to assist your firm in meeting CGMP requirements," it added.
 Until all corrections have been completed and USFDA has confirmed corrections of the violations and the firm''s compliance with CGMP, the regulator may withhold approval of any new applications or supplements, it said.
 In addition, the company's failure to correct these violations may result in USFDA continuing to refuse admission of articles manufactured at the plant into the US, it added. MSS SR ABM
ABM

USFDA red flags Torrent Pharma's US-based plant for manufacturing violations

<ul><li>The Nifty Pharma index gained 2.82% during the early trading hour.</li><li>These were the top gainers in the Nifty Pharma pack.</li><li><a href="https://www.businessinsider.in/">Check out the latest news and updates on Business Insider.</a> </li></ul>The Nifty Pharma index gained 2.82% during the early trading hour. Pharma stocks have been on a roll over the past few days. Nifty Pharma index was trading 382.50 points higher, while the Nifty 50 index was up 44 points at 9:30 am. These were the top gainers in the Nifty Pharma pack: Lupin gained 7%, and Cipla was up 5% The shares of Lupin Limited gained 7%, and Cipla was trading 5% higher during the trade on September 18. The jump in the shares of the pharma companies came after its Irish-peer Perrigo voluntarily recalled albuterol inhalation. This development bodes well for Lupin and Cipla. Cipla launched gProventil in April this year, and Lupin’s gProAir is expected to be launched this month. Dr Reddy’s Laboratories gains 4% Dr.Reddy’s Laboratories was the third-largest gainer in the Nifty pharma pack, trading almost 4% higher. The company has announced a settlement of litigation with a unit of Bristol Myers Squibb related to patents for Revlimid (lenalidomide) capsules, used to treat various kinds of cancer. “We are pleased with the settlement agreement, and look forward to bringing a generic version of lenalidomide to market soon subject to regulatory approval for the benefit of patients,” Dr Reddy’s Laboratories North America Generics CEO Marc Kikuchi said. Other pharma stocks surge in trade as well Other pharma were also trading higher fueled by the rally in the pharma sector. Sun Pharma, Divi’s Laboratories, Aurobindo Pharma and Torrent Pharmaceuticals are all up over 2%. SEE ALSO: <a href="https://www.businessinsider.in/stock-market/news/top-stocks-to-watch-dr-reddys-laboratories-hdfc-bank-tvs-motor-vedanta-irctc-lt-bharat-forge-hal-and-more/articleshow/78179393.cms" data-type="tilCustomLink">Top stocks to watch— Dr Reddy's Laboratories, HDFC Bank, TVS Motor, Vedanta, IRCTC, L&amp;T, Bharat Forge, HAL, and more</a> <a href="https://www.businessinsider.in/sports/news/dailyhunt-app-founders-confirm-ipl-2020-associate-sponsorship/articleshow/78169667.cms" data-type="tilCustomLink">EXCLUSIVE: Dailyhunt founders confirm IPL 2020 associate sponsorship — promise new release for Josh ahead of India’s biggest cricket tournament</a>

Top pharma stock movers — Lupin, Cipla, Dr Reddy’s steal the show

New Delhi, Mar 9 () Torrent Pharmaceuticals on Monday said it has received shareholders' nod to raise up to Rs 5,000 crore through various instruments, including qualified institutional placement (QIP).In a filing to the BSE, the company said around 99.299 per cent votes were cast in favour of "issuance of equity shares including convertible bonds/debentures through QIP and/or depository receipts or any other modes for an amount not exceeding Rs 5,000 crore."The approval of the shareholders was sought by way of special resolution through a postal ballot, the filing said. SID SID ANUANU

Torrent Pharma gets shareholder nod to raise up to Rs 5,000 cr

<ul><li>The American drug regulator approved 953 new generic drugs between October 2018 and June 2019.</li><li>This is the highest number of approvals in the first nine months of any fiscal year from the USFDA, according to a report.</li><li>While the new approvals will put pressure on existing drugs to be cheaper, the silver lining for companies is that new applications have slowed down.</li></ul>The United States Food and Drug Administration (USFDA) has generously doled out approvals for new drugs and that is likely to show in the profits of Indian drug makers like <keyword id="44642" type="CITY" weightage="20" keywordseo="Sun-Pharma">Sun Pharma</keyword>, <keyword id="46698" type="CITY" weightage="20" keywordseo="Lupin">Lupin</keyword>, <keyword id="7875008" type="UNKNOWN" weightage="20" keywordseo="dr-redddys-laboratories">Dr Redddy's Laboratories</keyword>, and <keyword id="70473" type="COMPANY" weightage="20" keywordseo="Aurobindo-Pharma">Aurobindo Pharma</keyword> when the earnings start tumbling out this month. The American drug regulator approved 953 new generic drugs between October 2018 and June 2019. This is the highest number of approvals in the first nine months of any fiscal year from the USFDA, according to a report from Ashika Institutional Research. Companies have been battling the pricing pressure in US for a while now and the profit squeeze has taken a lot out of stock prices in recent years. On one hand, there is a two-pronged pressure consistently squeezing drug prices-- one from <a href="https://www.businessinsider.in/The-Trump-administration-has-a-little-known-practice-in-the-pharma-industry-in-its-crosshairs/articleshow/64124087.cms" data-type="tilCustomLink" target="_blank">the Donald Trump administration</a> and the other from the <a href="https://www.livemint.com/market/mark-to-market/us-disruption-may-have-singed-indian-pharma-but-it-is-emerging-stronger-1557253325315.html" data-type="tilCustomLink" target="_blank">rising competition</a> in generic drugs. Over the past three years, sales per marketed product (in US) have declined by about 30%, according to a report by global investment bank Nomura in March 2019. At the same time, <a href="https://www.businessinsider.in/seven-indian-pharma-companies-are-being-dragged-into-a-us-lawsuit-over-high-drug-prices/articleshow/69318841.cms" data-type="tilCustomLink" target="_blank">seven Indian companies</a> -- Sun Pharma, Dr Reddy’s Laboratories, Glenmark Pharma, Lupin, Wockhardt, Zydus Pharma and Aurobindo Pharma-- are facing a lawsuit in over 40 American states for acting like a cartel to keep drug prices up. "However, given intensifying competition due to faster generic approvals and regulatory headwinds, the litigation raises the risk associated with the US generics business for companies involved in the litigation," a report from an Indian brokerage, Motilal Oswal, on May 14 said. At rock bottom While the new approvals will put pressure on existing drugs to be cheaper, the silver lining for companies is that new applications have slowed down. "We are seeing mild slowdown with total 696 ANDAs submitted in the first 9 months of the fiscal year, down 8% (YoY). As major generic companies continue to exit unattractive products, ANDA (generic drug) submissions are seeing this slowdown," the report said. In terms of profit margins, Indian drug makers, who rely a lot on the US market for their revenue, have little to lose and a lot to gain from the low base of previous years. According to estimates from Karvy, the margin for most companies is expected to have widened significantly in the three months ended June 2019, compared to the same period a year earlier. <table style="width: 166pt;"> </colgroup> <tbody><tr> <td class="xl66" style="height:15.0pt;width:82pt">Company</td> <td class="xl67" style="border-left-width: initial; border-left-style: none; width: 84pt;">Profit Margin</td> </tr> <tr> <td class="xl68" style="height: 15pt; border-top-width: initial; border-top-style: none;">Lupin</td> <td class="xl69" style="border-top-width: initial; border-top-style: none; border-left-width: initial; border-left-style: none;">+732 basis points</td> </tr> <tr> <td class="xl68" style="height: 15pt; border-top-width: initial; border-top-style: none;">Sun Pharma</td> <td class="xl69" style="border-top-width: initial; border-top-style: none; border-left-width: initial; border-left-style: none;">-253 basis points</td> </tr> <tr> <td class="xl68" style="height: 15pt; border-top-width: initial; border-top-style: none;">Torrent Pharma</td> <td class="xl69" style="border-top-width: initial; border-top-style: none; border-left-width: initial; border-left-style: none;">+118 basis points</td> </tr> <tr> <td class="xl68" style="height: 15pt; border-top-width: initial; border-top-style: none;">Cadila Health</td> <td class="xl69" style="border-top-width: initial; border-top-style: none; border-left-width: initial; border-left-style: none;">-45 basis points</td> </tr> <tr> <td class="xl68" style="height: 15pt; border-top-width: initial; border-top-style: none;">Dr Reddy's Labs</td> <td class="xl69" style="border-top-width: initial; border-top-style: none; border-left-width: initial; border-left-style: none;">+217 basis points</td> </tr> <tr> <td colspan="2" class="xl70" style="border-right:1.0pt solid black; height:15.0pt;width:166pt">Source: Karvy Stock Broking </td> </tr> <tr> <td colspan="2" class="xl72" style="border-right:1.0pt solid black; height:15.75pt">100 basis points make 1%</td> </tr></tbody></table> SEE ALSO: <a href="https://www.businessinsider.in/donald-trump-on-generic-drugs-indian-pharma-and-katherine-ebans-new-book-with-dinesh-thakur/articleshow/69407566.cms" data-type="tilCustomLink" target="_blank">The man who brought Ranbaxy to its knees is pushing for ‘Made in India’ tag on drugs sold in US</a>

USFDA has set a new record in generic drug approvals this year-- but Indian drug makers have a lot to gain and little to lose

New Delhi, Jan 27 () Drug firm Torrent Pharmaceuticals on Monday reported a 2.03 per cent rise in its consolidated net profit to Rs 251 crore for the quarter ended December 31, 2019.
The company had posted a net profit of Rs 246 crore for the corresponding period previous fiscal, Torrent Pharmaceuticals said in a BSE filing.
Consolidated revenue from operations of the company stood at Rs 1,966 crore for the quarter under consideration. It was Rs 2,051 crore for the same period a year ago.
The company's board has approved the re-appointment of Samir Mehta as Executive Chairman of the company for the period of 5 years effective from April 1, 2020, the filing said.
Shares of Torrent Pharmaceuticals closed at Rs 2,026.85 per scrip on the BSE, down 0. 49 per cent from its previous close. AKT AKT BAL
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