Shilpa Medicare Unit VI gets GMP approval from EMA
Karnataka: Shilpa Medicare has announced that the company's Unit VI, Dabaspet, Bengaluru, Karnataka, India has received GMP approval from European Medicines Agency (EMA).
The inspection was conducted by Finnish Medicine Agency on behalf of EMA, from March 10 – 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.
Oral Mouth Dissolving Films and Transdermal Systems are both, technology intensive, niche and complex dosage forms which offer significant advantages over conventional oral dosage forms in terms of patient convenience, dosing compliance and quick or sustained drug delivery for local and systemic therapy. This Unit is currently supplying Oral Film products to US and other markets.
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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.
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Shilpa is an integrated pharmaceutical group with business interests in niche Oncology & Non-oncology APIs, Peptides, Polymers, differentiated finished dosage formulations including novel injectables, orally dispersible films & transdermal patches along with carefully crafted biological portfolio. Shilpa also provides end-to-end CDMO services to global pharmaceutical companies across all its business segments based on its R&D and manufacturing capabilities backed by four R&D units and seven manufacturing facilities.
