Shilpa Medicare Ltd Receives GMP Approval from EMA for Unit VI in Bengaluru

Shilpa Medicare Limited, Unit VI, Dabaspet, Bengaluru, Karnataka, India has received GMP approval from EMA (European Medicines Agency) for manufacturing, packaging, testing, storage and distribution of two types of complex dosage forms - Oral Mouth Dissolving Films and Transdermal Systems. The inspection was conducted by Finnish Medicine Agency on behalf of EMA, from March 10 — 14, 2025. This approval will enable the company to secure approval and market its range of Oral Film products and Transdermal Patches in the entire European Union. The unit is already approved by MHRA, UK and TGA, Australia and currently supplying Oral Film products to US and other markets. The company has a pipeline of products under the Oral Film and Transdermal Patch dosage forms which are approved, under approval and in advanced stages of development.