ORCHID'S BETALACTAM API PLANT APPROVED BY UK REGULATORS

Orchid Chemicals & Pharmaceuticals announced that its betalactam active pharmaceutical ingredient (API) facility in Aurangabad, India, has been approved by the UK's Medicines and Healthcare Products Regulatory Agency (MHRA).

The MHRA approval is an important step in the overall regulatory road map for Orchid's main generic betalactam product, piperacillin/tazobactam, in European markets, according to the company. It also signifies the first major international approval for the Aurangabad API manufacturing plant.

Piperacillin/tazobactam, an injectable antibiotic, is marketed by Wyeth as Zosyn.

In September 2006 the MHRA approved Orchid's two sterile cephalosporin manufacturing facilities near Chennai, India. The company plans to begin marketing generic cephalosporin products in Europe early this year.