After discussion with the Food and Drug Administration (FDA), the companies recently elected to drop the 32-case interim analysis and conduct the first interim analysis at a minimum of 62 cases, the statement said.
If the DCGI grants regular marketing authorisation, Covishied will be the second vaccine in the world to receive such approval.
Ranbaxy Laboratories on Wednesday said it has received USFDA tentative approval for Sumatriptan Succinate tablets.\n\n
The alternative, saline implants, rupture too, but such failures are quickly recognised by women as their breasts deflate.
In March, the FDA had issued an import alert, banning formulations and active pharmaceutical ingredients from the factory.
The Bharatiya Janata Party in Maharashtra objected to the pharma executive's grilling by Mumbai police, saying the Shiv Sena-led government in the state was playing politics amid the pandemic.
There is no evidence that the drug can fight the virus, and regulators warn it may cause heart problems.
The FDA actions eventually led to a $500-million fine for Ranbaxy as well as the effective mothballing of many of its Indian factories.
The United States has so far allocated only 7.5 million doses of Covid vaccines to India, which is not enough, a top Indian-American Congressman said while urging the Biden Administration to do more.
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.
Some Indian generic drugmakers are, however, uncertain about the pace of approvals in the near future.
"Confidence in the vaccine is what brings us here this morning," the US vice-president said in remarks following his vaccination. "I didn't feel a thing. Well done."
With the maximum dose gap of four months for Covishield, a large part of the population would not even be eligible for the second dose by the end of this year, report Ruchika Chitravanshi and Ishaan Gera.
Ranbaxy on Tuesday announced it had got final approval from the US Food and Drug Administration to market its Metformin HC1 tablets for diabetes.
Ranbaxy Laboratories on Thursday said that it had received final approval from US Food and Drug Administration to manufacture and market Ciprofloxacin.
Dr Reddy's Laboratories Limited announced on Thursday that the United States Food and Drug Administration has issued final approval for the company's abbreviated New Drug Application for Ciprofloxacin tablets 100 mg, 250 mg, 500 mg and 750 mg.
Ranbaxy Laboratories Ltd has received the US Food and Drug Administration approval to market Fosinopril sodium tablets in the United States.
Ranbaxy Laboratories on Monday said it has received tentative approval from the United States Food and Drug Administration to manufacture and market anti-hypertension drug Quinapril Hydrochloride in the US.
Rosier year-end seen for Indian pharma thanks to faster US approvals.
The company was indicted for violations at one of its US facilities in 2009, even after Daiichi Sankyo took over as majority shareholder in 2008.
In April, Snapdeal had said it was delisting the drugs from its portal and was assisting the regulator in the investigation.
The Indian Council of Medical Research will start national-level sero surveys to assess the spread of Covid-19 and all states/Union territories should also be encouraged to conduct them so that information from all geographies can be collected, the Union health ministry said on Friday.
Ranbaxy Laboratories on Tuesday said it had received approval from US Food and Drug Administration to market a semi synthetic cephalosporin Panixine DisperDose, a generic version of Ceph International Corp, Keflex.
Flipkart, Amazon, too, under radar
Ranbaxy Laboratories and the US health regulator are reportedly negotiating a settlement.
Lupin Ltd received US Food & Drug Administration's approval for its abbreviated new drug application for Cefuroxime Axetil tablets.
Ranbaxy Laboratories has received tentative approval form the Food & Drug Administration USA for manufacturing and marketing Fluconazole tablets
Ranbaxy's US factory, Ohm Laboratories, is learnt to have got a clean chit from the American regulator. This US facility was under surveillance of the Food and Drug Administration (FDA) since the end of 2012.
The FDA had imposed a ban on the company's Waluj plant in May.
Glenmark said it along with its US-based partner has got the US health regulator's nod to manufacture and market two oxycodone products, used for treating moderate to severe pain, in the American market. The company's US arm, Glenmark Generics Inc and Lehigh Valley Technologies (LVT) have received US Food and Drug Administration nod for Oxycodone immediate release capsules, the company said in a filing to the Bombay Stock Exchange.
According to the chairman, there will be an annual loss of Rs 100 crore due to the MHRA alert on Waluj plant
'WHO issued an emergency use listing for Covovax, expanding the basket of WHO-validated vaccines against COVID-19. The vaccine is produced by the Serum Institute of India under licence from Novavax,' the world health body said in a tweet on Friday.
India consistently ranked among the top three countries whose products were rejected for import by the regulator.
FDA allows Teva to launch Nexium generic; Cipla, which supplies formulation, to gain
The FDA issued the letter on October 15, and has given the company 15 days to respond.
The central government is importing COVID-19 vaccines and is in talks with COVID-19 vaccine manufacturers Pfizer and Johnson & Johnson, Union Minister of State for Home Affairs G Kishan Reddy said.
'We are in close touch with Indian officials at all levels. We are also closely coordinating with our allies, friends, and Quad partners about how we can collectively support India in its hour of need,' a senior Biden administration official told reporters
Ranbaxy, which is 63.5 per cent-owned by Japan's Daiichi Sankyo Co and gets more than 40 per cent of its sales from the United States, did not immediately respond to a request on Wednesday for comment on the FDA observations.
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