Orchid Pharma completes USFDA inspection at Alathur API facility with seven minor observations

Orchid Pharma has completed a surprise inspection by the U.S. Food and Drug Administration (USFDA) at its Active Pharmaceutical Ingredient (API) manufacturing facility in Alathur, Tamil Nadu. The inspection took place from 10 February 2025 to 18 February 2025 and resulted in seven minor observations, none related to data integrity.

The facility continues to be India’s only USFDA-approved site for Sterile Cephalosporins. The inspection outcome confirms Orchid Pharma’s compliance with USFDA regulatory standards.

The Alathur facility specialises in the production of Cephalosporin antibiotics, a category of drugs used globally. Orchid Pharma has stated its commitment to maintaining regulatory standards and ensuring an uninterrupted supply of these antibiotics to the U.S. and other international markets.

The facility has also secured the renewal of its EU Good Manufacturing Practice (GMP) certificate following a successful inspection. This certification confirms compliance with European regulatory standards and enables continued supply to global markets.

Manish Dhanuka, Managing Director, Orchid Pharma, said, “The successful completion of the USFDA inspection underscores our unwavering commitment to quality, compliance, and global regulatory standards. Our teams have consistently worked towards upholding the highest manufacturing practices, ensuring the continued supply of world-class antibiotics. As India’s only USFDA-approved facility for Sterile Cephalosporins, we take immense pride in maintaining this exclusive status that sets us apart in the global pharmaceutical landscape. The renewal of the EU GMP certificate further strengthens our position as a trusted pharmaceutical manufacturer for global markets.”

Orchid Pharma continues to expand its presence in international pharmaceutical markets with these regulatory milestones, reinforcing its role in antibiotic manufacturing.