Shilpa Medicare Secures EIR with VAI Status from USFDA for Bengaluru Facility

Raichur, Karnataka | July 16, 2025: In a regulatory development that reinforces its global pharmaceutical compliance track record, Shilpa Medicare Limited (BSE: 530549, NSE: SHILPAMED) has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its Unit VI facility in Dabaspet, Bengaluru. The inspection, conducted from October 24 to October 30, 2024, has concluded with a VAI (Voluntary Action Indicated) classification.

This successful inspection outcome marks a positive compliance milestone for Shilpa Medicare and validates its adherence to Good Manufacturing Practices (GMP) for complex pharmaceutical dosage forms.

What the VAI Classification Means

A VAI (Voluntary Action Indicated) classification means that the USFDA found minor GMP issues that do not warrant regulatory action, and the facility remains in good standing. It is an acceptable outcome and allows Shilpa Medicare to continue its existing and planned product supply to the US market from the facility.

The VAI status also makes the facility eligible for future product approvals by the USFDA, subject to product-level reviews.

About Unit VI – Dabaspet, Bengaluru

Unit VI is a specialized manufacturing plant capable of handling two complex dosage forms:

• Oral Dissolving Films (ODF): Thin film drug delivery format placed on the tongue for rapid release.

• Transdermal Systems: Drug patches designed to deliver medications through the skin into the bloodstream.

The unit is a strategic asset for the company’s global expansion strategy in novel drug delivery systems.

Global Regulatory Accreditations

Apart from the USFDA, Unit VI is also approved by major international regulatory agencies, including:

• EMA (European Medicines Agency) – Europe

• MHRA (Medicines and Healthcare products Regulatory Agency) – United Kingdom

• SFDA (Saudi Food and Drug Authority) – Saudi Arabia

• TGA (Therapeutic Goods Administration) – Australia

This multinational compliance coverage positions Shilpa Medicare as a trusted CDMO (Contract Development and Manufacturing Organization) partner in multiple regulated markets.

Export Capabilities & Commercial Outlook

• The unit is already exporting Oral Film products to the US and other regulated markets.

• Transdermal drug delivery products manufactured at this unit have been filed for approval in European markets, expanding the company’s therapeutic footprint in advanced drug delivery mechanisms.

The company’s ability to manufacture and export innovative dosage forms is central to its growth in value-added formulations and next-generation delivery platforms.

Leadership View

While the press release didn’t include a direct quote, this regulatory success reflects Shilpa Medicare’s long-standing commitment to operational excellence, global compliance, and high-quality manufacturing standards.

It further enhances the company’s credibility in complex product development—a space with higher entry barriers, better margins, and sustained demand across the US and EU pharmaceutical landscapes.

What Is an EIR and Why Is It Important?

The Establishment Inspection Report (EIR) is a document issued by the USFDA after a pre-approval or routine surveillance inspection. It formally communicates the agency's final review and classification of the inspection findings.

Receiving an EIR with a VAI status means:

✅ No critical observations
✅ The site is compliant with USFDA GMP regulations
✅ The company is allowed to continue or commence supply to the US market

This status is closely watched by investors, regulators, and industry partners as it reflects the company’s quality assurance capabilities.

Impact on Shilpa Medicare’s Market Position

Shilpa Medicare’s latest regulatory clearance:

✅ Strengthens its position as a reliable pharmaceutical exporter to the US
✅ Boosts credibility in complex generics and novel delivery systems
✅ Supports its regulatory pipeline for transdermal and oral film products
✅ Provides supply continuity assurance to its partners and customers
✅ May attract new CDMO partnerships from global players

About Shilpa Medicare Limited

Shilpa Medicare Limited, headquartered in Raichur, Karnataka, is a publicly listed pharmaceutical company with a 35+ year legacy. The company develops, manufactures, and exports complex generics, oncology products, injectables, APIs, and novel drug delivery systems.

Business verticals include:

• Finished Dosage Formulations

• Active Pharmaceutical Ingredients (APIs)

• Novel Drug Delivery Systems (ODF, Transdermal)

• Biologics and Biosimilars (under development)

• CDMO Services for Global Clients

With a growing regulatory portfolio and focus on complex products, Shilpa Medicare continues to emerge as an integrated pharmaceutical player catering to regulated markets like the US, Europe, and beyond.

Conclusion

The receipt of an EIR with VAI classification from the USFDA for its Bengaluru Unit VI is a positive development for Shilpa Medicare Limited. It demonstrates the company’s continued commitment to regulatory compliance, manufacturing excellence, and innovation in drug delivery technologies.

As the pharmaceutical landscape becomes increasingly specialized, such achievements not only build investor confidence but also pave the way for new product approvals, exports, and strategic partnerships in global markets.

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