In a setback to pharmaceutical major Ranbaxy Laboratories Ltd, the US drug regulator USFDA has directed the company to recall as many as 7.32 crore (73.2 million) Gabapentin tablets of 600 and 800 mg strengths.
The recalled drug bottles were distributed by Caraco Pharmaceutical Laboratories, Ltd in the US while manufactured in India by Sun Pharmaceutical Industries Ltd.
Ranbaxy's hope of a windfall from the $7-billion Lipitor market in the US is shining again. The US Food and Drugs Administration (USFDA) has taken a strong stance against US-based Mylan, which had opposed FDA's decision to allow approval to Ranbaxy's generic version of Lipitor.
Earlier in April, Pfizer said that it had offered a not-for-profit price for its vaccine for the government immunisation programme in India and it remains committed to continuing engagement with the government to make the vaccine available in India.
Providence will sell up to 30 mn doses of its mRNA vaccine to Biological E. It would also provide the necessary technology transfer to make the vaccine in India, with a minimum production capacity of 600 mn doses in 2022 and targets capacity of 1 bn doses, reports Sohini Das.
The company is set to deliver the first set of 20,000 vials in two equal lots of 10,000 each, one of which will be immediately supplied to Hyderabad, Delhi, Gujarat, Tamil Nadu, Mumbai and other parts of Maharashtra, Hetero Healthcare said in a statement.
The US Food and Drug Administration (USFDA) has asked Caraco Pharmaceutical Laboratories, the US subsidiary of Mumbai-based Sun Pharmaceuticals Industries, to withdraw many batches of its generic Metformin Hydrochloride tablets used for treating diabetes, citing efficacy and quality issues. According to a USFDA Class II withdrawal announced on March 19, Caraco will have to withdraw seven lots of Metformin Hydrochloride in bottles of 100, 500 and 1000 tablets each.
Calling for 'equal recognition of vaccines', COVAX on Thursday urged all governments to recognise as 'fully vaccinated' those people who have received COVID-19 vaccines deemed safe by World Health Organisation, saying any move that restricts travel of people based on the vaccines they have received is 'counter-effective, both in spirit and outcome'.
Sputnik V is the third vaccine India has given the go-ahead to after 'Covishield', developed by Oxford University and AstraZeneca and 'Covaxin', the indigenous vaccine manufactured by Bharat Biotech. Covishield is manufactured by the Serum Institute of India.
The vaccine would be first made available to the vulnerable population and eventually, it would be available in the private market for all.
Pharma shares were the top gainers led by Lupin after the company received EIR from USFDA for its Goa facility
Sun Pharma Ltd has received tentative approval for cancer drug Ondansetron from US Food and Drug Administration.
Ranbaxy Laboratories on Wednesday said it has received USFDA tentative approval for Sumatriptan Succinate tablets.\n\n
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.
According to The New York Times, this move means that many highly vulnerable people will begin receiving the vaccine within days. It further called the authorisation by the FDA as a 'historic turning point' as the US death toll from the Wuhan-originated virus nears 300,000.
Ranbaxy Laboratories Ltd on Friday said it has received approval from the US Food and Drug Administration to manufacture and market multiple dosages of anti-diabetes drug Glimepiride tablets.
"Vaccination is our big weapon in the fight against COVID-19," he said. He added that India is the fastest country globally to reach the landmark of 17 crore doses in 114 days and thanked all the states and UTs for their contribution in achieving this feat.
As marketing rights for off-patent drugs in the US become less exclusive, companies are scrambling for fresh strategies to make up for the revenue loss.
Facing accusations of delay in placing orders for vaccines, the government on Thursday defended its vaccine procurement policy saying it has been pursuing Pfizer, J&J and Moderna since mid-2020 for the earliest possible imports, and has even waived local trials for well-established foreign vaccine makers.
Check out some of the stocks that will react on the basis of their numbers in the near term.
We must resist the temptation to look at the absolute numbers being vaccinated, and focus instead on the percentage of the population vaccinated, he said in his letter.
Dr Reddy's gets warning from US health regulator
An advocate on Wednesday approached the Supreme Court with a PIL seeking cancellation of the license granted to Ranbaxy Laboratories and for initiating probe against the pharma major for allegedly manufacturing and selling adulterated drugs.
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As per the media report, the US Food and Drug Administration is learnt to have issued a Form 483 to the company's manufacturing facility at Mohali a few months ago after finding deviations from norms during an inspection of the plant.
Pharma was the top losing index amid worries about their earnings outlook with Lupin down over 4%
A popular energy drink, produced by a company founded by an Indian-American billionaire, has come under the scanner in the United States after reports of 13 deaths possibly linked to the energy shots.
Sun Pharma would have to do a lot of work to get USFDA to revoke the ban on Ranbaxy facilities but it has not put any time-frame for this, company ChairmanIsrael Makov said.
After spending considerable time and energy in remediation efforts in the wake of the US Food and Drug Administration's warning letter on compliance issues, the company's leadership has finally set out to bring the house in order.
Import alert on unit-6 facility might be lifted by FDA by Sept.
USFDA consent decree reveals that firm will have to forego huge short-term opportunities for its generics.
Sitharaman, a newcomer on the Forbes most powerful women list, is ranked 34th. The Forbes 2019 list of 'The World's 100 Most Powerful Women' has been topped by German Chancellor Angela Merkel, followed by President of the European Central Bank Christine Lagarde in the second spot and Speaker of the US House of Representatives Nancy Pelosi, ranked third. Also on the list is Bangladesh Prime Minister Sheikh Hasina (29).
Cipla is recalling the drug for failed impurities and degradation specifications.
Hyderabad, Mar 28 (PTI) Dr Reddy's Laboratories Limited has launched Levocetirizine tablets (5mg), a bio-equivalent generic version of Xyzal tablets in the USA market, the company said on Monday.
United States Food and Drug Administration (USFDA) has given final approval to Glenmark Generics Inc for their abbreviated new drug application (ANDA) for Norgestimate and Ethinyl Estradiol tablets USP in the strengths of 0.18 mg/0.035 mg, 0.215 mg/0.035 mg and 0.25/0.035 mg, the company said in a statement.
Orchid Chemicals & Pharmaceuticals on Monday said it has received US health regulator's approval to sell anti-epileptic levetiracetam tablets in the American market.
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.
Nestl India is preparing a blueprint for a possible relaunch.
The Supreme Court on Monday posed some tough questions to a lawyer, asking him to substantiate his "unfounded allegations" in a PIL that Indian pharma major Ranbaxy Laboratories Ltd was allegedly manufacturing and selling adulterated medicines.
Sun Pharmaceutical Industries and its subsidiary, Caraco Pharmaceutical Laboratories, have reached a settlement agreement with drugmaker Forest Laboratories and licensing partner H Lundbeck AS, over a pending patent infringement dispute over Forest's blockbuster antidepressant, Lexapro.
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