June 19, 2007:  Ipca granted U.S.FDA approval for Hydroxychloroquine Sulfate Tablets

Third Product approval under the alliance with Ranbaxy

Ipca Laboratories Ltd. (Ipca) has received approval from U.S. 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 U.S. were US $ 50 millions (IMS-MAT:March ’07).

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

Initially, Ranbaxy will manufacture and market this formulation in the US healthcare system using Ipca’s DMF approved Active Pharmaceutical ingredient (API) – Hydroxychloroquine Sulfate. In future, Ipca will manufacture this formulation utilizing its facilities in India. Ipca is setting up a new formulations manufacturing facility meeting U.S. regulatory requirements at SEZ Indore, India.

Ipca is one of the largest producer in the world of API Hydroxychloroquine Sulfate and holds its DMFs in various countries. Ipca is also marketing formulations of Hydroxychloroquine Sulfate in various markets. This approval will further strengthen Ipca’s global market share of this product.

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

Ranbaxy Laboratories Limited, headquartered in India, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy's continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. The Company's foray into Novel Drug Delivery Systems has led to proprietary "platform technologies," resulting in a number of products under development.  The Company is serving its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 11 countries

Ipca is a Mumbai based fast growing fully integrated pharmaceutical Company engaged in the manufacturing and marketing of a range of pharmaceuticals world over with a strong thrust on exports.  Ipca’s exports to over 110 countries across the globe contributed about 53% of the Company’s total income of Rs. 921 crores in the financial year 2006-07.

Premchand Godha

Managing Director

 Mumbai
 June 19, 2007