Strides Arcolab has bagged a US FDA inspection approval status for its Bangalore facility after a GMP and pre-approval inspection at its sterile complex which was audited for cGMP compliance.

The field inspections are mandatory during filing of Abbreviated New Drug Agency (ANDA). Strides has 14 sterile approvals from the US FDA and 51 ANDA application pending with US FDA.

During the inspection, no 483 observations were issued. In 2008, the Penicillin Block was also approved without any 483 observations. The 483 observations are captured during the inspections to assess the quality control standards of the facility, personnel and systems in the company, stated Venkat Iyer, CEO, India Operations, Strides Arcolab.

The company's Sterile complex has three dedicated blocks manufacturing: penicillin, cephalosporin and injectables in dry powder, liquid vials, prefilled syringes and lyophilised products. Last year, the company invested Rs 3,500 million to expand its steriles production expanding capacity by over 500 per cent.

Four new sterile complexes are expected to be inspected in 2009.These include oncology and new complex for sterile injectables in Bangalore. The other two are international plants: One is a controlled substances facility in Poland and the other is the Penem facility in Campos, Brazil, which is a joint venture initiative with Aspen.

According to Venkat Iyer, CEO, India Operations, "A Zero 483 approval for compliance in a challenging manufacturing and regulatory environment the Pharma industry is currently facing is indeed a landmark."