Shilpa Medicare Limited, a leading name in the Indian pharmaceutical sector, has achieved a major regulatory milestone. The company's Unit VI located at Dabaspet, Bengaluru, Karnataka, has received Good Manufacturing Practice (GMP) approval from the European Medicines Agency (EMA). This achievement positions Shilpa Medicare for deeper expansion into European pharmaceutical markets with its advanced drug delivery products.

Inspection and Certification Details

The GMP inspection was conducted by the Finnish Medicines Agency, acting on behalf of the EMA, during the period of March 10 to 14, 2025. Following the inspection, only a few minor observations were noted, indicating a high standard of compliance. Based on this, EMA granted GMP approval for the manufacturing, packaging, testing, storage, and distribution of two sophisticated pharmaceutical forms — Oral Mouth Dissolving Films and Transdermal Systems.

What Are Oral Films and Transdermal Systems?

Both dosage forms are considered technology-intensive and niche within the pharmaceutical industry.

• Oral Mouth Dissolving Films are ultra-thin strips containing medication that dissolve quickly in the mouth without water. These are particularly beneficial for pediatric, geriatric, and dysphagic patients.

• Transdermal Systems, commonly known as patches, deliver drugs through the skin in a controlled and sustained manner, offering systemic therapy while bypassing the gastrointestinal system.

These advanced formulations offer superior dosing compliance, enhanced convenience, and faster or sustained drug delivery, making them a preferred choice over traditional tablets or capsules for many therapies.

Previous Approvals Already in Place

Before this EMA certification, Shilpa Medicare's Unit VI had already secured approvals from the MHRA (UK) and the TGA (Therapeutic Goods Administration, Australia). These credentials underline the unit’s global regulatory readiness and its robust quality standards.

What This Means for Shilpa Medicare

This EMA approval now opens up access to the entire European Union market, allowing Shilpa Medicare to:

• Secure approvals and commercialize its existing range of Oral Film products and Transdermal patches across EU nations.

• Expand its product footprint in regulated markets, enhancing brand visibility and market share.

• Build deeper partnerships with European pharmaceutical companies seeking reliable manufacturers of high-tech dosage forms.

The company is already supplying Oral Film products to the US and other markets, and this new certification is expected to boost exports further and strengthen its global supply chain.

Product Pipeline and Development

Shilpa Medicare revealed that it has a strong pipeline of products under the Oral Film and Transdermal Patch categories. These include:

• Approved Products – Ready for scaling up and export.

• Under Approval – Products being reviewed by regulatory agencies.

• Advanced Stage Development – Products nearing finalization before submission.

With such a diversified and advanced portfolio, the company is well-positioned to become a major global player in the complex dosage forms segment.

Strategic Advantage

EMA approval brings significant competitive advantage. In an era where patient-centric drug delivery systems are gaining traction, Shilpa Medicare’s technological capabilities in thin film and patch-based therapies can fulfill unmet needs in chronic disease management, mental health, pain relief, and hormone replacement therapies.

The European pharmaceutical market is highly regulated and lucrative. Being EMA-certified enables Shilpa Medicare to participate in tenders, partner with large multinational firms, and access patients across the EU bloc without additional regulatory barriers.

Conclusion

This landmark EMA GMP certification reaffirms Shilpa Medicare's standing as a quality-conscious, innovation-led pharmaceutical manufacturer. With existing regulatory approvals from the US, UK, and Australia, and now the EU, the company is strategically positioned to serve high-value global markets. The focus on complex, high-margin dosage forms will likely fuel long-term revenue growth and enhance shareholder value.

As the company continues to invest in R&D, product innovation, and regulatory compliance, it is expected to emerge as a preferred outsourcing partner for global pharma giants seeking expertise in niche drug delivery technologies.

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