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www.fdanews.com/articles/62719-orchid-receives-uk-regulatory-approval-for-two-plants

ORCHID RECEIVES UK REGULATORY APPROVAL FOR TWO PLANTS

September 22, 2006

Orchid Chemicals & Pharmaceuticals announced that its two sterile facilities for manufacturing cephalosporin formulations and active pharmaceutical ingredients located in near its headquarters in Chennai, India, have received approval from the UK's Medicines and Healthcare Products Regulatory Agency (MHRA).

The approvals followed MHRA inspections of the plant to validate Orchid's quality, regulatory and compliance standards. The company will now be able to receive UK marketing authorizations for its products based on MHRA review.

The company plans to launch generic cephalosporin products on the European market as early as next year, and it has already submitted applications for marketing approval to the MHRA. The company has already received FDA approval for its plants and has won several generic drug approvals in the U.S.