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Shilpa Medicare receives GMP approval from European Medicines Agency
May-06-2025

Shilpa Medicare has received GMP approval from EMA (European Medicines Agency) for its Unit VI located at Bengaluru, Karnataka. The inspection was conducted by Finnish Medicine Agency on behalf of EMA, from March 10 to March 14, 2025 and concluded with few minor observations. This GMP approval is for manufacturing, packaging, testing, storage and distribution of two types of complex dosage forms being produced from this facility -Oral Mouth Dissolving Films and Transdermal Systems. The Unit is already approved by MHRA, UK and TGA, Australia.

This Unit is currently supplying Oral Film products to US and other markets. 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 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. 

Shilpa Medicare produces and exports consistently high-quality Active Pharmaceutical Ingredients Fine Chemicals, intermediates, herbal products and speciality chemical products using sophisticated technology, meticulously following international specifications.

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