In a setback that could potentially delay the launch of Bharat Biotech's Covid-19 vaccine Covaxin in USA, the Food and Drug Administration there has "recommended" Ocugen Inc, the US partner of the Indian vaccine maker, to go for Biologics Licence Application (BLA) route with additional data, nixing hopes of Emergency Use Authorisation.
Gland Pharma, promoted by China's Fosun, has extended its gains, is up 40 per cent since its listing.
According to the petition copies, Hospira has alleged that Aurobindo's Abbreviated New Drug Application (ANDA) to make generic version of dexmedetomidine hydrochloride injection would infringe its patented drug Precedex.
Maharashtra government on Friday decided to put a ban on Maggi noodles after some samples were found to contain lead above the permissible limit.
The company's market value rose by Rs 1,684.87 crore.
Ankleshwar plant is the third such facility to face action
In April, Snapdeal had said it was delisting the drugs from its portal and was assisting the regulator in the investigation.
The Johnson and Johnson vaccine, which works with one dose instead of two, got approval on Saturday, the third vaccine cleared in the country after emergency use authorisation (EUA) was given to two-dose shots from Pfizer and Moderna in December last year.
Ohm Laboratories Inc, a wholly-owned subsidiary of Ranbaxy has received approval from the US Food and Drug Administration for manufacturing and marketing Valsartan tablets in strengths of 40 mg, 80 mg, 160 mg, and 320 mg on an exclusive basis, Ranbaxy Laboratories said in a statement.
As the pandemic spreads and the urgency for effective treatment of COVID-19 mounts, several countries, including the US, have started relying heavily on HCQ, majorly used in the treatment of malaria and rheumatoid-arthritis.
The weakness in the stock was because of inspections by the American drug regulator at its Halol plant in Gujarat which resulted in eight observations, as well as a downward revision of speciality drug payoffs.
The move comes in the wake of many facilities of Ranbaxy in India being barred by the US Food and Drugs Administration for supplying medicines to the US.
Shares of Ranbaxy Laboratories on Friday slumped as much as 20 per cent in the morning trade after the USFDA prohibited the company from producing and distributing drugs for the American market from its Toansa plant in Punjab.
US firm Mylan NV received a stern warning from the FDA in August for faulty manufacturing practices at three of its India drugmaking plants.
India is engaged with American entities for procurement of COVID-19 vaccines from the United States and their possible manufacturing in the country subsequently, the Ministry of External Affairs said on Thursday.
Portfolios were distributed 2 weeks after the MVA govt was sworn-in. Shiv Sena's Eknath Shinde will be home minister while NCP's Jayant Patil will be finance minister.
The FDA has been tightening its monitoring of Indian pharma majors over compliance issues. Surprise plant inspections and import alerts have been frequent outcomes
FDA inspectors visited the Mohali plant in the process of giving approval to Ranbaxy's application for Valsartan.
Health officials have previously raised the possibility that the public may need booster COVID-19 shots.
The US Food and Drug Administration has asked USV to probe employees who might have been responsible for inaccurate data reporting.
Fund managers said investors remained positive on the pharma manufacturing activity in India, which further strengthened during the Covid-19 period, on account of restrictions imposed on pharma imports from China.
Dilip Shanghvi founded Sun Pharma in 1983.
The state government had in the first week of June banned Maggi sale in the state after the product failed the food safety test.
The Oxford/AstraZeneca vaccine is also being produced as part of a tie-up by the Serum Institute of India.
Under terms of the agreed deal, Ranbaxy shareholders will get 0.8 of a Sun Pharmaceutical share for each Ranbaxy share they own.
Despite unprecedented levels of uncertainty in Samvat 2077, investors have little to complain about on the returns front. The BSE Sensex delivered returns of 38 per cent in this period, while the Nifty registered a return of over 40 per cent. As is the case in bull markets, companies in the small- and mid-capitalisation basket outperformed the benchmarks, with returns almost twice those of frontliners.
The sale of gutka would be booked under non-bailable sections regarding the offence
US District Judge Beryl Howell in Minneapolis denied Ranbaxy's request, the court filing showed.
With all major US export-oriented drug manufacturing plants in the country up for inspection in 2022, some estimates peg that at least 20-30 per cent of the new product launches lined up for the US will be subject to on-site inspection by the US Food and Drug Administration (USFDA). The last two years saw limited physical inspections due to travel restrictions during the pandemic. "Pre-Covid, the frequency and number of inspections of manufacturing plants in India by USFDA had increased significantly," analysts from ICICI Securities Research noted. "With growing ANDA filings, especially for complex products. "We expect this trend to return with the environment normalising," analysts from ICICI Securities Research noted.
Sun Pharma stated the company wanted shareholders' approval to "issue, offer and allot equity shares or non-convertible securities, other than warrants, up to an amount of Rs 12,000 crore ($2 billion), to qualified institutional buyers pursuant to a QIP."
Researchers at Northwell Health in New York are testing the effects on Famotidine (used in high intravenous doses) on Covid-19 patients as a potential treatment. After the hospital announced its clinical trials, it led to a drug shortage in the US. Back home, however, there has not been any surge in the demand for Famotidine yet.
Prosecutors unveiled charges against Valvani alleging he fraudulently made $25 million by getting advance information about US Food and Drug Administration approvals of generic drug applications
India on Tuesday temporarily licensed the export of paracetamol and anti-malarial drug Hydroxychloroquine in appropriate quantities to some countries, which have been particularly badly affected by the coronavirus pandemic.
The recalled drugs were manufactured and distributed in the US by Ohm Laboratories.
While the US health regulator did not specify details for issuing the alert, it said 'detention without physical examination may be appropriate when an FDA inspection has revealed that a firm is not operating in conformity with current good manufacturing practices'.
The FDA had imposed a ban on the company's Waluj plant in May.
Goa on Sunday joined several other states in banning the sale of Nestle's instant noodle brand 'Maggi' which is at the centre of a raging nationwide row over food safety concerns.
Adar Poonawalla said he was hopeful that Covovax, the Novavax vaccine made by SII, will be launched around October this year for adults and for children by the first quarter of next year, depending on DCGI approvals.
Speaking at the Conservative Political Action Committee in Orlando, Florida on Sunday, the 74-year-old leader, who left the White House on January 20, stopped short of announcing to run for the president in 2024, although he gave enough indications that he is moving in that direction.
All of Ranbaxy's India-based factories are currently banned by the FDA from exporting medicines to the United States, the company's largest market, after the regulator's inspection found violation of its so-called good manufacturing practices.
