USFDA approval for Orchid

Chennai: Orchid Chemicals & Pharmaceuticals, a city-based bulk drug major, has formally received the approval from the United States Food and Drugs Administration (USFDA) for its sterile API (active pharmaceutical ingredient) product Cefazolin.

The USFDA authorities inspected the plant this September. An important sterile cephalosporin antibiotic API, Cefazolin is used in the treatment of several infections. Orchid has established world-class sterile lyophilisation and non-sterile facilities for integrated manufacture of this product.

"This is definitely a very key development for Orchid and another significant milestone in our regulatory roadmap. This approval will enable a strong entry for our sterile injectable product, Cefazolin, into the US market. We hope to start exports of this product to the US soon," says Orchid managing director Raghavendra Rao.