Aurobindo Pharma Gets EMA Nod for Biosimilar Facility

New Delhi, Nov 12 (PTI) Aurobindo Pharma on Tuesday said its unit has received GMP certificate of compliance for its Hyderabad-based biosimilars manufacturing facility from the European Medicines Agency.

CuraTeQ Biologics, a wholly-owned subsidiary of Aurobindo Pharma, has received the certification.

The GMP inspection, conducted by European Medicines Agency (EMA) representatives from April 8th to April 12th, 2024, assessed mammalian and microbial drug substance manufacturing facility sections, prefilled syringes and vials filling, packaging, and QC testing and release laboratories, the Hyderabad-based drug maker said in a regulatory filing.

"The EU GMP certification marks a significant milestone in CuraTeQ's commitment to manufacturing high-quality biosimilars for patients worldwide," Aurobindo Pharma Director and CEO of Biologics, Vaccines, and Peptides Satakarni Makkapati said.

This inspection outcome paves the way for securing approvals for the company's three biosimilars in Europe, currently under review by the Agency, within the next two to five months, he added.

Aurobindo Pharma shares of Tuesday ended 1.59 per cent down at Rs 1,267.40 apiece on BSE.