IPCA plans to set up 2 API facilities and laboratories at research and development centre in MP and signs MOU with Ranbaxy Pharmaceuticals Inc. for manufacturing and marketing metformin HCL tablets in US
Ipca Laboratories Ltd, a Mumbai-based Rs 900 crore pharmaceutical company is setting up two new API manufacturing facilities and laboratories at research and development centre in Ratlam, Madhya Pradesh. The expansion is expected to be completed by the end of November 2007.
The company is investing Rs 70 crore for setting up two new API facilities and Rs five crore for setting up additional lab. The new API facility will mainly focus on the hydrocloroquinsulfate and metformin for the anti-malaria and anti-diabetic segment.
Every year the company is producing 10-12 new APIs for the domestic market. The company has overall strength of 5,000 employees. Among them 1000 people are working in the API manufacturing facility at Ratlam. The company has almost 250 scientists in its research and development centre in MP.
During the year its API and intermediate business recorded a growth of 14 per cent to Rs 281.90 crore and nearly 75 per cent of the API and intermediate business is coming from export. In the last financial year, the company had commissioned its new manufacturing unit at Baddi and commercialized its nine APIs for domestic and international markets.
The company has also initiated Drug Master Files (DMF) registration activities. Currently, company has filed 23 DMFs and around 31 DMFs are in the pipeline for the US FDA. It has also received certificate of suitability (COS) for the 12 APIs from the European Directorate for Quality Medicines (EDQM) for the EU countries.
Recently, Ipca had made a strategic alliance with Ranbaxy Pharmaceuticals Inc. (Ranbaxy) based in Jacksonville, Florida (USA), a wholly owned subsidiary of Ranbaxy Laboratories Ltd. (RLL). Ohm Laboratories Inc. (Ohm), wholly owned subsidiary of RLL has received approval from US Food and Drugs Administration to manufacture and market metformin hydrochloride USP tablets 500mg, 850mg and 1000mg in the US market. Total annual market sales for metformin HCL tablets in US were US$ 379 millions. This is the fifth such product approval received under the alliance from US FDA.
The company will manufacture this formulation utilizing its facilities in India. The company is setting up a new formulation manufacturing facility meeting US regulatory requirements at SEZ Indore. The company is already holding US DMF of metformin HCL. Ranbaxy will commercialise this product in the US market utilizing its established marketing expertise and distribution network.