Dalal Street Investments
Top

Panacea Biotec + Ranbaxy US FDA

October 4, 2007

Panacea Biotec has entered into a MOA with Family Vaccines, Philippines to provide access to value added combination vaccines under the umbrella of easy vaccines manufactured by the company, to the people in Philippines through a chain of 50 immunization clinics, run by Family Vaccines.

Philippines has a birth cohort of around 2.5 million with an EPI immunization coverage of about 80%. At a GNI per capita at US $ 1170 and a GDP per capita at US $ 4614, Philippines has been accorded a developing country status. The global vaccine market is expected to top US $ 10 billion in 2007 and US $ 23.8 billion in 2012.

Ranbaxy Laboratories on 04 October 2007 the company has received final approval from U.S. FDA to manufacture and market clarithromycin for oral suspension, USP, 125 mg/5 ml and 250 mg/5 ml. The company is the first company to have been granted a generic approval for the oral suspension form along with clarithromycin tablets. Total annual market sales for clarithromycin were $99.7 million with suspension sales totaling $25.3 million.

The office of generic drugs, U.S. FDA, determined the Ranbaxy formulation to be bioequivalent and to have the same therapeutic effect as that of the reference listed drug Biaxin Granules (clarithromycin for oral suspension, USP), 125 mg/5 ml and 250 mg/5 ml of abbott laboratories.

Comments

Got something to say?






Bottom