Shilpa Medicare's Bengaluru Facility Receives EMA GMP Certification for Advanced Drug Delivery Systems
核心洞察
Shilpa Medicare (搜索)'s Unit VI in Bengaluru has secured Good Manufacturing Practice (GMP) certification from the European Medicines Agency (搜索) following a successful inspection with only minor observations.
The certification covers manufacturing, packaging, testing, storage, and distribution of two complex dosage forms: Oral Mouth Dissolving Films (搜索) and Transdermal Systems (搜索), expanding the company's European market access.
The Bengaluru facility, already approved by UK's MHRA and Australia's TGA, currently supplies Oral Film products to the US and other international markets with a robust pipeline of products in various stages of development.
Shilpa Medicare (搜索) Limited has secured Good Manufacturing Practice (GMP) certification from the European Medicines Agency (搜索) (EMA) for its Unit VI facility in Dabaspet, Bengaluru, Karnataka. The approval follows a successful inspection conducted by the Finnish Medicines Agency (搜索) on behalf of the EMA between March 10-14, 2025, which concluded with only minor observations.
The certification specifically covers the manufacturing, packaging, testing, storage, and distribution of two advanced pharmaceutical dosage forms: Oral Mouth Dissolving Films (搜索) (ODFs) and Transdermal Systems (搜索). Both delivery systems represent technology-intensive, niche pharmaceutical formats that offer significant advantages over conventional oral medications.
"The approval received from EMA will help Shilpa Medicare (搜索) to secure approval and market its range of Oral Film products and Transdermal Patches in the entire European Union," the company stated in its press release dated May 6.
Advanced Drug Delivery Systems
The newly certified dosage forms provide distinct benefits for patients and clinicians alike. Oral Mouth Dissolving Films (搜索) and Transdermal Systems (搜索) enhance patient convenience and improve dosing compliance while enabling either rapid or sustained drug delivery for both local and systemic therapeutic applications.
These specialized delivery systems represent a growing segment in pharmaceutical development, particularly valuable for patients with swallowing difficulties, those requiring precise dosing, or conditions benefiting from controlled release mechanisms.
Expanding Global Regulatory Approvals
The Bengaluru facility has already received accreditation from other major international regulatory bodies, including the UK's Medicines and Healthcare products Regulatory Agency (MHRA) and Australia's Therapeutic Goods Administration (TGA).
Unit VI currently supplies Oral Film products to the United States and other international markets, demonstrating the facility's compliance with global pharmaceutical manufacturing standards. The EMA certification further strengthens Shilpa Medicare (搜索)'s position in the global pharmaceutical landscape.
Product Pipeline and Market Expansion
According to the company's announcement, Shilpa Medicare (搜索) has developed a substantial pipeline of products utilizing these specialized dosage forms. This portfolio includes products that have already received regulatory approval, applications pending approval, and candidates in advanced stages of development.
The EMA certification positions the pharmaceutical company to expand its European market presence, bringing its innovative drug delivery systems to patients across the European Union. This regulatory milestone supports Shilpa Medicare (搜索)'s strategy to focus on complex, high-value pharmaceutical products.
Market Response
Following the announcement, Shilpa Medicare (搜索)'s shares were trading 1.84% lower at ₹655.45 apiece on the BSE as of 12:43 pm on the day of the announcement, according to market data from CNBC-TV18.
The company's continued investment in specialized manufacturing capabilities and regulatory approvals reflects its commitment to developing advanced pharmaceutical technologies that address specific patient needs while expanding its global market footprint.