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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. 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 is a manufacturer of API, formulation, and development services. Shilpa Medicare (SML) started its operations as an API manufacturer way back in 1987 at Raichur, Karnataka, India. The company had reported a consolidated net profit of Rs 31.78 crore in Q3 FY25, which is significantly higher as compared with the PAT of Rs 4.58 crore posted in Q3 FY24. Revenue from operations for the third quarter was at Rs 319.32 crore, up 11.35% year on year. Shares of Shilpa Medicare declined 2.16% to Rs 653.35 on the BSE. Powered by Capital Market - Live News |