Shilpa Medicare Ltd has bagged the Certificate of Suitability of Monographs from the European Directorate for the Quality of Medicines (EDQM) for the Active Pharmaceutical Ingredient (API) Gemcitabine HCI EP.

With this approval the Raichur-based company can penetrate the European Markets, according to Vishnukant Bhutada, managing director, Shilpa Medicare.

Gemcitabine is in a class of drugs known as pyrimidine analogs. It slows or stops the growth of cancer cells.

The worldwide sale for Gemcitabine in 2006 was valued at US$ 1.1 billion and is growing at 28 per cent annually.

Early this year, the company bagged the certificate of suitability of monograph from the EDQM for the active pharmaceutical ingredient, Oxaliplatin EP. It was the first company in India and globally to bag the certificate of suitability for this product. The product is used for the treatment of metastatic rectal colon cancer after prior treatment with fluropyrimidines in mono-chemotherapy or associated treatment.

Shilpa is a leading oncology API manufacturer in the country and globally. Its capability spans from APIs, intermediates to multi-market finished packs. The products are manufactured at its WHO GMP facility certified since 1995, located at Raichur. Also the company has the Certificate of Suitability from EDQM for Ambroxol HCl, Ticlopidine, Carboplatin, Buflomedil HCl and a Korean FDA approval for Ambroxol HCl. Its expertise is in the area of customs research-manufacturing (CRAMS) and has leading global pharma majors among its clients.