Orchid Pharma announced the successful completion of a surprise U.S. Food and Drug Administration (USFDA) inspection at its Active Pharmaceutical Ingredient (API) manufacturing facility in Alathur, Tamil Nadu. The inspection, which commenced on 10 February 2025 and concluded on 18 February 2025, resulted in seven minor observations, none of which pertain to the data integrity of the facility. This successful inspection maintains Orchid Pharma's distinguished position as India's only USFDA-approved facility for Sterile Cephalosporins. It reaffirms Orchid Pharma's compliance with USFDA regulatory standards, reinforcing the company's commitment to quality and excellence in pharmaceutical manufacturing.
The Alathur facility specializes in the production of Cephalosporin antibiotics, a critical class of life-saving drugs. Orchid Pharma remains committed to maintaining the highest standards in pharmaceutical manufacturing to ensure continuous supply to the U.S. and global markets.
Additionally, the Alathur API facility has also secured the renewal of its EU Good Manufacturing Practice (GMP) certificate following a successful inspection. This further validates the facility's compliance with European regulatory requirements and its capability to serve global markets.