Shilpa Medicare secures EU GMP approval for Bengaluru unit

Shilpa Medicare announced today that its Unit VI facility in Bengaluru, India, has secured Good Manufacturing Practice (GMP) approval from the European Medicines Agency (EMA). The approval follows an inspection conducted by the Finnish Medicine Agency on behalf of EMA between March 10th and 14th, 2025. The GMP approval covers the manufacturing, packaging, testing, storage, and distribution of Oral Mouth Dissolving Films and Transdermal Systems. With this approval, Shilpa Medicare can now pursue approvals and market its oral film products and transdermal patches across the European Union, adding to its existing supply to the US market.