Parabolic Drugs get Japanese ministry’s accreditation for cephalosporin drugs

31 Oct 2011 Evaluate

Parabolic Drugs (PDL) has received an official accreditation from Japan's ministry of Health, Labour and Welfare, enabling it to manufacture and supply Cephalosporin non sterile drugs to the Japanese market. The 5-year accreditation has been awarded to PDL's manufacturing site at Derabassi in Punjab and is in accordance with article 13-3 of the Pharmaceutical Affairs Act, which classifies Parabolic Drugs as a certified foreign drug manufacturer.

Japan, the second single largest drug market in the world is also a leading nation in terms of pharma research, technology, machinery and medical research and is valued at $107 billion in 2010. The Japanese certification denotes the company's technical capability in the non-sterile market and also differentiates it from many of its competitors.

The EU GMP accredited Derabassi facility is a dedicated Cephalosporin manufacturing site that is spread across 27 acres and has an annual capacity over 900 tons of Cephalosporin. This accreditation is an essential element of company's regulatory market vision as the Japanese market is an arena it hopes to heighten its market presence.

The company sees an opportunity in building its regulated market business in the $21 billion global Cephalosporin molecule market and has over 38 DMFs filed across EU, Canada and USA. It also has over 3 molecules in pipeline for filing it in Japan. The company's exports accounted for 36.98% of the total revenues in FY11, with direct exports alone accounting to 28.21%.   

Parabolic Drugs is Chandigarh based contract manufacturer of active pharmaceutical ingredients (APIs). Currently, it has six units at Sundhran, Derabassi, for manufacturing the oral and sterile range of Cephalosporin APIs and intermediates.

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