Anuh Pharma’s manufacturing facility found compliant during EDQM regulatory audit
EDQM had conducted the audit at the bulk drug company’s manufacturing facilities located at Tarapur
Anuh Pharma has cleared the good manufacturing practice (GMP) milestone after undergoing an audit from the European Health regulator, the company informed in its filing with the stock exchanges.
The European Directorate for the Quality of Medicines & HealthCare (EDQM) had conducted the audit at the bulk drug company’s manufacturing facilities located at Tarapur – 125 km from Mumbai, in India’s western state of Maharashtra.
“We are pleased to inform you that the facilities were found to be compliant during the Audit. The successful outcome of the inspection reaffirms the Company’s continued adherence to global regulatory and quality compliance standards,” the filing said.
EDQM GMP approval, often evidenced by a Certificate of Suitability (CEP) or inspection report, means an active pharmaceutical ingredient (API) manufacturer complies and meets its standards for quality, safety and traceability for the European market.
This approval is integral to marketing authorisation applications for medicines in the EU, as it proves that the substances in the medicine are produced according to high, harmonised standards.
Anuh Pharma, which derived around 55 percent of its revenue from exports in the financial year 2024-25 (Apr-Mar), has strong marketing partnerships with 360 customers in over 59 countries including Europe, Mexico and South Africa and has reported revenue of USD 62 million for the nine-month period ended in December 2025.
It is one of the largest manufacturers of Macrolides and Anti‐TB products in India, besides being a major player in Anti‐bacterials, Anti‐malarial, Anti‐hypertension and Corticosteroids.
It may be recalled that in December, the company had received Certificate of Suitability from EDQM for Sulfadimethoxine and last month in February, its Tarapur facility had completed inspection from the US drug regulator without no Form 483 observations issued.