Govt to ease hepatitis B vaccine potency test norm
Hepatitis B vaccine manufacturers would no more need to undertake potency tests for each batch of production.

DRL files lawsuit against Pfizer, enters into OTC drug pact with Leiner
Dr Reddy’s Laboratories has filed a lawsuit seeking declaratory judgement against Pfizer in the United States District Court for the District of New Jersey regarding its Abbreviated New Drug Application (ANDA) for Sertraline HCl, the generic version of Pfizer’s Zoloft.

Ranbaxy gets tentative USFDA nod for benazepril tablets
Ranbaxy Laboratories Limited (RLL), has announced that Ranbaxy Pharmaceuticals Inc (RPI), a wholly owned subsidiary of RLL has received tentative approval from the Food and Drug Administration to market Benazepril Hydrochloride tablets in 5mg, 10mg, 20mg and 40mg strengths.

Kopran gets MCC approval for ibuprofen in South Africa
THE pharmaceuticals company, Kopran Ltd has obtained the registration approval for its brand Bren-400 (ibuprofen tablets) by the Medicines Control Council (MCC) of South Africa.

Ind-Swift gets DCGI nod for clarithromycin
IND-Swift has received the Drug Controller General of India’s (DCGI) nod for manufacturing and marketing anti-infective drug Clarithromycin.

US FDA approves Orchid’s cephalexin
The Chennai-based pharma company, Orchid Chemicals and Pharmaceuticals Ltd, announced that its flagship product Cephalexin has been formally approved by the United States Food and Drug Administration (US FDA) Pursuant to the successful USFDA audit in November last year, Orchid has now received a formal approval from the USFDA authorities, stated a company release.

AT A GLANCE