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Anuh Pharma Clears EDQM GMP Audit for Tarapur Manufacturing Facility

12 Mar 2026
Admin
News Article

Anuh Pharma Clears EDQM GMP Audit for Tarapur Manufacturing Facility

Anuh Pharma has successfully cleared a Good Manufacturing Practice (GMP) audit conducted by the European Directorate for the Quality of Medicines & HealthCare (EDQM).

The inspection took place at the company’s active pharmaceutical ingredient (API) manufacturing facility in Tarapur, Maharashtra, about 125 km from Mumbai. Following the audit, the European regulator confirmed that the facility meets global quality and regulatory compliance standards.

What the GMP Approval Means?

EDQM GMP approval indicates that an API manufacturer complies with strict European standards for:

Quality
Safety
Traceability

This certification is typically supported through a Certificate of Suitability (CEP) or inspection report.

For pharmaceutical companies exporting to Europe, such approvals are critical. They demonstrate that the active substances used in medicines are produced according to harmonized EU standards, which is a key requirement for marketing authorization applications across the region.

Strengthening Global Regulatory Credibility

The successful audit reinforces Anuh Pharma’s commitment to maintaining high manufacturing and regulatory standards.

According to the company’s regulatory filing, the positive inspection outcome confirms that the Tarapur facility fully complies with global regulatory expectations, strengthening the company’s position in regulated markets.

A Major Export-Oriented API Manufacturer

Anuh Pharma continues to expand its presence in international markets. Key highlights from the company’s recent performance include:

55% of total revenue came from exports in FY 2024–25
Partnerships with over 360 customers worldwide
Presence in 59+ countries, including Europe, Mexico, and South Africa
USD 62 million in revenue reported for the nine months ending December 2025

This global footprint makes regulatory approvals like EDQM inspections particularly important for sustaining international supply chains.

Strong Portfolio in Anti-Infective APIs

Anuh Pharma is among the largest manufacturers of macrolide antibiotics and anti-tuberculosis APIs in India.

The company also produces a wide range of active ingredients used in therapies such as:

Anti-bacterials
Anti-malarials
Anti-hypertension drugs
Corticosteroids

This diversified portfolio supports both domestic and export pharmaceutical markets.

Recent Regulatory Milestones

The EDQM audit success follows several other recent regulatory achievements for the company.

Notably:

In December, the company received a Certificate of Suitability (CEP) for sulfadimethoxine from EDQM.
In February, the Tarapur facility completed an inspection by the U.S. Food and Drug Administration with no Form 483 observations issued.

These developments strengthen the company’s regulatory standing in both European and U.S. pharmaceutical markets.

Looking Ahead

With successful regulatory inspections from both European and U.S. authorities, Anuh Pharma is well-positioned to expand its global API supply footprint.

For pharmaceutical buyers and drug manufacturers, consistent compliance with international GMP standards remains a key factor in selecting reliable API suppliers.