Orchid Chemicals and Pharmaceuticals, the Chennai-based global pharma major, received approval from UK MHRA for its sterile cephalosporin finished dosage form (formulations) and active pharmaceutical ingredients (APIs) facilities located near Chennai in Irungattukottai and Alathur respectively.
These approvals, which followed the facility inspections conducted in the respective locations by the Agency, validate the quality, regulatory and compliance standards of Orchid. 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 Orchid'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. 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", said K Raghavendra Rao, Managing Director, Orchid Chemicals and Pharmaceuticals Ltd.