Shilpa Medicare Unit VI facility at Dabaspet receives GMP certification from SFDA

This was a full GMP inspection of the entire facility with specific focus on Ondansetron Oral Film drug product

Shilpa Medicare’s Unit VI facility located at Dabaspet, Bengaluru, Karnataka, has received SFDA, Saudi Arabia, GMP certification.

This follows the on-site inspection of this Site from 18-20th Feb 2025. This was a full GMP inspection of the entire facility with specific focus on Ondansetron Oral Film drug product. The inspection was closed with ZERO observations.

This facility of Shilpa Medicare is engaged in the manufacture, testing, storage, and release of finished dosage forms in the category of Oral Films and Transdermal Patches. Oral Films are currently being supplied from this site to the US, Australia, and other emerging countries. The site is approved by the European Medicine Agency, Europe following a recent inspection by Finnish regulators.