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Obamacare, buyouts boost India's tally of ANDAs

Nov 25 2013, 08:53 IST
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ANDA pertains to a generic drug that is therapeutically equivalent to an already approved innovator drug but is exempt from the requirements of clinical trials data for regulatory validation. ANDA pertains to a generic drug that is therapeutically equivalent to an already approved innovator drug but is exempt from the requirements of clinical trials data for regulatory validation.
SummaryOne in four abbreviated new drug applications approved by regulator in 2012 belonged to Indian company.

boundaries when Sandoz acquired US generic drugmakers Fougera Pharmaceuticals and Ebewe Pharma.

While the Big Pharma companies like Merck and GlaxoSmithKline keep their distance from the generic drugs market or set up a subsidiary that handles the business — for example, US-based Roxane Labs is a subsidiary of Germany’s Boehringer Ingelheim — Pfizer stands apart from its peers in the data examined. The world’s largest drug company by revenue received 16 ANDAs from January 2007 to October 2013.

On a company-wise basis, Mylan, which ranks second globally among generic drugmakers, tops the list with 207 ANDA approvals to its credit in the seven-year period. Teva has 153 approvals and ranks third.

Indian companies have faced various compliance issues in 2013 with overseas health regulators — the USFDA and the UK’s Medicines and Healthcare products Regulatory Agency — finding Indian manufacturing facilities failing to meet the good manufacturing standards laid out by them. With top Indian companies like Ranbaxy and Wockhardt under the scanner, it was assumed that approvals from the regulators would be hard to come by.

But the numbers show that despite the problems, Indian companies are still getting the USFDA nod. Since late May — when Wockhardt’s troubles first cropped up — Indian companies have received approval for 60 ANDAs, compared with 45 approvals the US companies have got.

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