The API facility of the Chennai-based pharma major Orchid Chemicals & Pharmaceuticals Limited was inspected by a team of officials from the European Directorate for Quality of Medicines (EDQM) and the Medicines and Healthcare Products Regulatory Agency (MHRA) of UK. The facility located at Alathur near Chennai have been inspected by the team on the full spectrum of sterile, non-sterile and oral API facilities last week and found the facilities and processes to be in compliance to the standards of EU-GMP.
Orchid has so far received three Certificates of Suitability (CoS) from the EDQM, for one sterile API and two non-sterile API’s. This inspection will further support the sale of Orchid’s range of cephalosporin bulk drugs (sterile & oral) in the high-growth European markets. As a result of this successful facility inspection, other CoS applications of Orchid pending approval with the EDQM will be cleared soon. Formal communication from both the authorities approving the facilities is expected in the near future.
Commenting on this successful inspection, K Raghavendra Rao, Managing Director, Orchid Chemicals & Pharmaceuticals Ltd. said, “This inspection is another significant achievement in our overall regulatory roadmap. This is the first time that the EDQM and MHRA have inspected our facilities. It is noteworthy that our systems and procedures were found to be in compliance with their standards. We are confident that these approvals will help us gain a stronger foothold in the regulated markets of Europe and UK. Over the last 10 months, our facilities have been inspected and approved by the USFDA, TGA–Australia and now EDQM and MHRA-UK.”