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“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,” the company said in a statement. As a result, Orchid Pharma continues to hold its exclusive position as India’s only USFDA-approved manufacturing site for sterile cephalosporins, it added.
The Alathur facility, known for its production of life-saving cephalosporin antibiotics, has long been a cornerstone of Orchid Pharma’s operations. In addition to this achievement, the facility has also secured the renewal of its European Union Good Manufacturing Practice (EU GMP) certification. This further reinforces Orchid Pharma’s adherence to European standards, solidifying its ability to serve key international markets.
Manish Dhanuka, Managing Director of Orchid Pharma, commented, “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.”
Shares of Orchid Pharma ended 1.2% higher at ₹828.25 on the BSE today.
