Shilpa Medicare Obtains EMA GMP Certification for Oral Mouth Dissolving Films & Transdermal Systems

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Shilpa Medicare Ltd is awarded Good Manufacturing Practice (GMP) certification by the European Medicines Agency (EMA) for its Unit VI facility in Bengaluru for oral mouth dissolving films and transdermal systems. This achievement enhances the global regulatory acceptability of the company and increases its market presence in Europe.

EMA GMP Approval for Unit VI

The certification authenticates Shilpa Medicare's commitment to rigorous European quality standards.
The company is specialized in the production, testing, and release of oral dissolving films and transdermal patches.

Enhancement of Product Portfolio

The approval will allow Shilpa Medicare to distribute advanced drug delivery systems to regulated markets.
The organization is emphasizing new-age formulations, enhancing patient compliance and convenience of administration.

Global Regulatory Approvals

Unit VI is already approved by MHRA-UK and TGA Australia, which strengthens its international credibility.
The company also has USFDA approval for nutraceutical oral film products.

Market Impact & Growth Strategy

The EMA certification reinforces Shilpa Medicare's European growth strategy.
The company is committed to expanding exports of oral dissolving films and transdermal patches.

Future Outlook & Industry Positioning

Shilpa Medicare continues to invest in R&D in the areas of oncology, peptides, and polymer-based formulations.
The company is dedicated to end-to-end CDMO services, facilitating global pharmaceutical companies.

This regulatory achievement underlines Shilpa Medicare's leadership in new drug delivery systems, setting the stage for greater global market presence.

Sources: Indian Pharma Post, Business Standard