Ajanta Pharma, a specialty focused pharmaceutical formulation company, has received approval from Medicines & Healthcare products Regulatory Agency (MHRA) of United Kingdom (UK) for its formulation manufacturing facility at Paithan, Aurangabad.
Ajanta's Paithan manufacturing facility is already approved by US FDA and has by now obtained the approval for one ANDA. Another ANDA is under approval and number of other ANDA's are in process of filing. Besides USA and UK, world's two most stringent regulatory approvals, Ajanta's Paithan facility also holds the WHO pre-qualification approval.
Commenting on the development, Yogesh Agrawal, managing director said. “We continue to build expertise in the quality standards and approvals from the most stringent regulatory authorities like USA, UK and WHO pre-qualification are testimony to our commitment towards quality. The foundation being laid down now shall assure sustained growth for the company in years to come. The approval is a significant milestone, paving the way for entry to the European Union market.”