Shilpa Medicare Limited has informed the Exchange about Approval by European Medicines Agency, for Shilpa Medicare Limited Unit VI, Bengaluru
SHILPAMED · price
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Shilpa Medicare's Unit VI facility in Dabaspet, Bengaluru has received GMP approval from the European Medicines Agency (EMA), following an inspection by the Finnish Medicine Agency from March 10–14, 2025 that concluded with only minor observations. The approval covers manufacturing, packaging, testing, storage and distribution of two complex dosage forms — Oral Mouth Dissolving Films and Transdermal Systems. The unit was already approved by UK MHRA and Australia's TGA, and is currently supplying Oral Film products to the US and other markets. With this approval, the company can now market its Oral Film products and Transdermal Patches across the entire European Union. The company has a pipeline of products in these dosage forms that are approved, under approval, or in advanced stages of development.
This opens up the lucrative European Union market for Shilpa Medicare's niche, technology-intensive dosage forms, potentially boosting future export revenues and order book. Positive for long-term growth, though the near-term stock impact may be modest until actual EU orders and revenues materialize.