The Chennai-based pharma major Orchid Chemicals & Pharmaceuticals Ltd. (Orchid) has said its API product Cefixime has been granted the Certificate of Suitability (CoS) by the European Directorate for the Quality of Medicines (EDQM). This is the 4th CoS that has been granted to Orchid.
“Cefixime is a product of considerable value in anti-infective treatment. This premium product has good potential for us”, said K Raghavendra Rao, managing director, Orchid Chemicals & Pharmaceuticals Ltd. Orchid has plans to further enhance the coverage of its products through CoS approvals for the European market.
Last week Orchid had formally received the approval from the US FDA authorities for its sterile API (Active Pharmaceutical Ingredient) product Cefazolin.
A team of officials also from the European Directorate for Quality of Medicines (EDQM) and the Medicines and Healthcare Products Regulatory Agency (MHRA) of UK also had inspected the API facility at Aalathur near Chennai recently. They had inspected the full spectrum of sterile, non-sterile and oral API facilities and found the facilities and processes to be in compliance to the standards of EU-GMP. With the approval for Cefixime, Orchid has received four Certificates of Suitability (CoS) from the EDQM, for one sterile API and two non-sterile API’s, besides TGA approval to enter the Australian and New Zealand markets.