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.

European Directorate for the Quality of Medicines & HealthCare (EDQM) had conducted the audit at the bulk drug company’s manufacturing facilities located at Tarapur, 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 market authorisation applications for medicines in the EU, as it proves that the substances in the medicine are produced according to high, harmonised standards.