Stridces facility approved by the USFDA for sterile products

Bangalore, May 25 (UNI) Strides Arcolab today announced that the USFDA had classified its sterile manufacturing site here as acceptable for manufacturing sterile products for the US market.

Strides Acrolab Vice Chairman and Managing Director Arun Kumar, in a release here, said that the approval by USFDA was an important milestone in the Company's US strategy.

This Pre-Approval Inspection (PAI) would support the product submissions for sterile injectables with the FDA, he added.

The sterile facility here manufactured injectables in Freeze-dried and Liquid Vials, Pre-filled Syringes and Dry Powder Sterile forms of Non-Penicillin and Non-Cephalosporin therapeutic formats. Out of the 33 submissions in 2006, 20 sterile injectables submissions were initiated from this site.

Strides is one of India's largest exporters of branded generic pharmaceutical products. It produced pharmaceuticals formulations in various dosage forms, including capsules, tablets, liquid injectables and was one of the world's top five manufacturers of soft gel capsules. Strides also has the only globally dedicated soft gel facility for hormones.

In addition, Strides undertook contract research and the manufacturing of specialty chemicals for various multinational companies. Strides has a major presence in various developing countries such as Africa, Latin America and Asia as well as in developed markets such as the US, Canada and part of Europe. Strides is one of the largest Indian suppliers of institutionally funded aid projects and is an approved supplier to the World Bank, the African Development Bank and UNI