Shilpa Medicare's Bengaluru facility secures GMP approval from EMA for Oral Mouth Dissolving Films and Transdermal Systems
By Aman Shukla Published on May 6, 2025, 12:01 IST
Shilpa Medicare Limited, a leading pharmaceutical company, has announced that its Unit VI facility in Dabaspet, Bengaluru, Karnataka has received Good Manufacturing Practice (GMP) approval from the European Medicines Agency (EMA). This milestone follows a successful inspection carried out by the Finnish Medicines Agency on behalf of EMA between March 10–14, 2025, which concluded with only minor observations.
The EMA GMP certification covers key operations at the facility, including the manufacturing, packaging, testing, storage, and distribution of two advanced pharmaceutical dosage forms: Oral Mouth Dissolving Films (ODFs) and Transdermal Systems.
This achievement marks a significant step forward for Shilpa Medicare, as both Oral Films and Transdermal Patches are complex, niche drug delivery systems. These dosage forms offer distinct advantages over traditional oral medications, such as enhanced patient convenience, improved dosing compliance, and efficient drug delivery — whether rapid or sustained — for local or systemic therapeutic needs.
Shilpa Medicare's Unit VI is already accredited by other major international regulatory agencies, including the UK's Medicines and Healthcare products Regulatory Agency (MHRA) and Australia's Therapeutic Goods Administration (TGA). The facility is currently supplying Oral Film products to the US and other international markets, highlighting its global compliance and capabilities.
With this EMA approval, Shilpa Medicare is now well-positioned to expand its presence across the European Union, bringing its innovative range of Oral Film and Transdermal Patch products to a broader patient population. The company also has a robust product pipeline in these dosage forms, which includes approved products, pending approvals, and candidates in advanced stages of development.
Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at BusinessUpturn.com
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