Orchid facilities get UK regulator's nod

Mumbai, Sep 21 (UNI) Orchid Chemicals and Pharmaceuticals today said its sterile cephalosporin Finished Dosage Form (formulations) and Active Pharmaceutical Ingredients (APIs) facilities near Irungattukottai and Alathur respectively in Chennai have received the approvals from the UK regulator, Medicines and Healthcare Products Regulatory Agency (MHRA).

In a notice to BSE, Orchid said these approvals, which followed the facility inspections conducted in the respective locations by the Agency, validate the quality, regulatory and compliance standards of the Company. These approvals will pave the way for receiving marketing authorizations for various products based on review of product dossiers by the regulatory authority.

''This is a very important milestone achieved in the Company's regulated market foray which has already made considerable strides in the US, based on several ANDA approvals received. The MHRA approvals will now support our European generic forays in a significant way,'' Company managing director K Raghavendra Rao said.

''We are targeting launch of key cephalosporin products starting next year in the European market, based on dossiers already filed and which are under submission. We hope to derive major revenues from the European generics thrust based on progressive receipt of marketing authorizations,'' he added.

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