News + Font Resize -

Ipca Lab gets US FDA nod for marketing hydroxychloroquine sulfate tabs
Our Bureau, Mumbai | Tuesday, June 19, 2007, 08:00 Hrs  [IST]

Ipca Laboratories Ltd has received approval from US Food and Drugs Administration to market hydroxychloroquine sulfate tablets USP - 200 mg in the US market. Total annual market sales for hydroxychloroquine sulfate tablets in US were US $ 50 millions.

Ranbaxy Pharmaceuticals Inc. (Ranbaxy), based in Jacksonville, Florida USA, will commercialise this product in the US market utilizing its established marketing expertise and distribution network. This is now the third product to receive US FDA approval for marketing under the company's alliance with Ranbaxy after Furosemide and Atenolol tablets.

Initially, Ranbaxy will manufacture and market this formulation in the US healthcare system using the company's DMF approved Active Pharmaceutical ingredient (API) - hydroxychloroquine sulfate. In future, the company will manufacture this formulation utilizing its facilities in India.

The company is setting up a new formulations manufacturing facility meeting US regulatory requirements at SEZ Indore, India. The Company is one of the largest producer in the world of API hydroxychloroquine sulfate and holds its DMFs in various countries. The company is also marketing formulations of hydroxychloroquine sulfate in various markets. This approval will further strengthen the company's global market share of this product.

The company has entered into a strategic alliance with Ranbaxy Pharmaceuticals Inc. (Ranbaxy), a wholly owned subsidiary of Ranbaxy Laboratories Ltd., in September 2006. Under the alliance, the company will develop a number of generic prescription pharmaceutical products which will be marketed by Ranbaxy in the US. Ranbaxy will file for regulatory approval and initially support manufacturing of these products. In the future, the company will manufacture such products utilizing their facilities in India. Most of these products will be supported using the company's DMF approved Active Pharmaceutical Ingredients (APIs).

Post Your Comment

 

Enquiry Form