Parabolic Drugs Ltd., a vertically integrated API manufacturer and exporter in India, announced that it has received an official accreditation from Japanâs ministry of Health, Labour and Welfare, enabling it to manufacture and supply Cephalosporin non sterile drugs to the Japanese market.
Speaking regarding the development, Vineet Gupta, utive Director, Parabolic Drugs Ltd., said, âWe at Parabolic have always focused on the production of class-leading pharmaceutical products, and this accreditation is a testament to our global standards in the manufacture of Cephalosporin drugs. We have been in the process of discussions with several Japanese firms for bulk supply deals to the Japanese market, and we believe that this accreditation will provide a further boost to our pursuit of forming a partnership with a Japanese firm in the near future.â
The 5-year accreditation has been awarded to PDLâs 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 USD 107 billion in 2010. The Japanese certification denotes the companyâs 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 Companyâs 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. In the FY 11, the companyâs exports accounted for 36.98 percent of the total revenues, with direct exports alone accounting to 28.21 percent.