USFDA concludes inspection at API manufacturing facility of Orchid Pharma

20 Feb 2025 Evaluate

U.S. Food and Drug Administration (USFDA) has concluded the inspection at Orchid Pharma’s Active Pharmaceutical Ingredient (API) manufacturing facility in Alathur, Tamil Nadu. The inspection, which commenced on February 10, 2025 and concluded on February 18, 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. With these regulatory milestones, Orchid Pharma continues to reinforce its reputation as a global leader in antibiotic manufacturing, supplying high-quality APIs to key international markets.

Orchid Pharma, established as an export-oriented unit (EOU), is a vertically integrated company spanning the entire pharmaceutical value chain from discovery to delivery with established credentials in research, manufacturing and marketing.

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