Aurobindo Pharma's Triumph: EU GMP Certification for Biosimilars

Aurobindo Pharma's subsidiary, CuraTeQ Biologics, has received a GMP certificate from the European Medicines Agency for its biosimilars manufacturing facility in Hyderabad. This certification from a recent inspection marks a major milestone, aiding in future approvals for the company's biosimilars in Europe.

Aurobindo Pharma announced on Tuesday that its subsidiary, CuraTeQ Biologics, has successfully received a GMP certificate of compliance from the European Medicines Agency. This certification pertains to their Hyderabad-based biosimilars manufacturing facility.

The inspection was conducted by the European Medicines Agency representatives between April 8th and 12th, 2024. It covered several aspects of the facility, including mammalian and microbial drug substance manufacturing, prefilled syringes and vials filling, packaging, and quality control testing.

Describing the certification as a significant milestone, Aurobindo Pharma Director and CEO of Biologics, Vaccines, and Peptides Satakarni Makkapati stated that it underscores their commitment to producing high-quality biosimilars for global patients. The certification could lead to approvals for three of the company's biosimilars in Europe within the next two to five months.

(With inputs from agencies.)