Chennai: The city-based bulk drug major Orchid Chemicals and Pharmaceuticals' active pharmaceutical ingredients (API) facility near Chennai has been successfully inspected by the European Directorate for Quality of Medicines (EDQM) and by the Medicines and Healthcare Products Regulatory Agency (MHRA, UK, formerly called MCA, UK).
The team representing both these regulatory agencies inspected 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 Chemicals has so far received three certificates of suitability (CoS) from EDQM, for one sterile API and two non-sterile APIs. This inspection will further support the company's sale of cephalosporin bulk drugs (sterile and oral) in the high-growth European markets.
As a result of this successful facility inspection, other CoS applications of Orchid Chemicals pending approval with EDQM will be cleared soon. Formal communication from both the authorities approving the facilities is expected in the near future.
Says Orchid managing director K Raghavendra Rao: "This inspection is another significant achievement in our overall regulatory roadmap. This is the first time that EDQM and MHRA have inspected our facilities. We are confident that these approvals will help us gain a stronger foothold in the regulated markets of Europe and the UK. Over the last 10 months, our facilities have been inspected and approved by US Food and Drugs Administration, TGA Australia and now EDQM and MHRA-UK."