If the DCGI grants regular marketing authorisation, Covishied will be the second vaccine in the world to receive such approval.
According to the chairman, there will be an annual loss of Rs 100 crore due to the MHRA alert on Waluj plant
Aurobindo Pharma Ltd on Tuesday said it has received tentative approval from the US FDA for its Sertraline
Various domestic companies such as Ranbaxy, Wockhardt and Agila Specialities recently came under the US FDA scanner for lapse in manufacturing practices.
Gland Pharma, promoted by China's Fosun, has extended its gains, is up 40 per cent since its listing.
FDA allows Teva to launch Nexium generic; Cipla, which supplies formulation, to gain
Inspections only in domestic authorities' presence, visiting US drug regulator told
With 62 filings, domestic pharma companies have filed the maximum number of drug master filings with the US Food and Drug Administration in the July-September 2006 quarter.
Slapped with Rs 242-crore fine by US authorities for rule violations at Toansa unit, say sources; 2nd such hefty rap in the recent past from US regulators for bending rules.
India's drug regulator Drugs Controller General of India has granted permission to Mumbai-based pharmaceutical company Cipla to import Moderna's COVID-19 vaccine for restricted emergency use in the country, official sources said on Tuesday.
Margaret A Hamburg, the first commissioner of the US Food and Drug Administration (US FDA) to visit India officially, will meet heads of major domestic pharma companies such as Ranbaxy, Wockhardt, Cadila Healthcare and Lupin in New Delhi.
'Pfizer India has submitted an application on December 4 to the DCGI seeking emergency use authorization for its COVID-19 vaccine in India'
The news that exports to the US will not restart before next year as well as the September quarter performance are sentiment dampeners.
Sun Pharma's acquisition of Ranbaxy has once again revived evaluation of the troubled past of the latter, which had changed hands from the promoters merely five years ago.
For Sun Pharma, it is an astute purchase that it hopes will not only boost its position in India but also globally.
The Japanese company alleges the earlier Ranbaxy promoters withheld crucial information when they sold the company in 2008.
The US drug regulator raised the issue of significant deviations from the current good manufacturing practice (cGMP) in three of DRRD's plants in a letter issued in November 2015
Work to begin after that on corrective measures to meet US regulator's requirements.
Regulator says fee would enable it to quicken approval process.
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.
This may include Rs 1,500 as a screening test for suspect cases and an additional Rs 3,000 for confirmation test, the guidelines said.
Last month, the US Food and Drugs Administration had placed Wockhardt's facilities in Waluj near Aurangabad on import alert, barring supply of various products from these facilities to the US.
Overall, the credit profiles of players will be supported by healthy balance sheets and liquidity. Prudence in capital and development expenditure, efficient working-capital management, and recent equity raising will help sustain credit metrics in FY22.
The United States Food and Drugs Administration has granted Ranbaxy Laboratories a tentative approval to market a generic form of Bristol-Myers' anti-depressant Serzone, US FDA's web site said.
'Nobody is attacking the company or the vaccine.' 'The concerns are about the process and the lack of transparency.'
The letter mentions certain cGMP violation based on site inspections conducted between July and August 2009.
The US Food and Drug Administration has seized drug products manufactured by Caraco Pharmaceutical, at the company's Michigan facilities in Detroit, Farmington Hills, and Wixom, the US FDA said on Thursday. The FDA seeks to immediately stop Caraco from further distributing drugs until there is assurance that the firm complies with good manufacturing requirements, it added.
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.
Earlier last month US FDA officials had seized drug products manufactured by Caraco Pharmaceutical at its Michigan facilities in Detroit, Farmington Hills, and Wixom, alleging violation in good manufacturing practice.
Reduction in customs duty on certain bulk drugs used in making life saving drugs to 5% is a positive for companies having product pipeline catering to these segments.
Takeda had filed a case of patent infringement in response to Zydus' abbreviated new drug application.
With the US education system operating independently from the government, universities are adopting varying strategies when it comes to Covid vaccination.
A team at Bristol University used recently developed techniques to validate that the vaccine accurately follows the genetic instructions programmed into it by the Oxford University team.
The ICMR has approved over 200 labs (both public and private) for COVID-19 testing through-PCR machines.
"We are responding to all queries from US FDA and will emerge as a stronger player in the world's biggest pharmaceutical market," Ranbaxy Chairman and Managing Director Malvinder Singh said. The US, which accounts for 20 per cent of Ranbaxy's $1.5-billion annual turnover, has an import restriction on 30 of its medicines by the US Food and Drugs Authority.
In 2014, Sun Pharma agreed to buy Ranbaxy -- which was then controlled by Daiichi.
Alembic Ltd has launched a 4th Generation Injectable Cephalosporin Cefepime under the brand name of Cepime.
Ranbaxy Laboratories on Wednesday hit out at rivals -- "a multinational and a leading Indian company" -- for trying to bring down its share by "spreading confusion and speculation" in the wake of a motion filed in the US accusing it of fraudulent practice and submission of false information to the US FDA.
Glenmark Pharmaceuticals Inc, has signed a $27 million royalty deal with international healthcare investment fund Paul Capital Partners' Royalty Fund to finance the development of 16 dermatological products by the pharma major for the US market.
DCGI, health ministry initiate dialogues with foreign regulators, try to understand global best practices
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