The UK drugs regulator, Medicines and Healthcare products Regulatory Agency (MHRA), has approved the Chennai-based pharma major Orchid Chemicals & Pharmaceuticals' its sterile cephalosporin formulations and active pharmaceutical ingredients facilities located in Irungattukottai and Alathur near Chennai.
These approvals will pave the way for Orchid receiving marketing authorisations for its drugs based on review of product dossiers by UK MHRA. The approvals were received following facility inspections conducted in both the locations by the Agency to validate the quality, regulatory and compliance standards of Orchid.
Orchid has already made considerable strides in the US through several ANDA approvals. The MHRA approvals will now support the company's introduction of generic products in Europe.
"We are already targeting the launch of key cephalosporin products starting next year in the European market, based on dossiers already filed and those that are under submission," says K Raghavendra Rao, managing director, Orchid Chemicals & Pharmaceuticals. "We hope to derive major revenues from the European generics thrust based on progressive receipt of marketing authorizations," Rao added.