Orchid Pharma’s Alathur API Facility Passes USFDA Inspection

Orchid Pharma Ltd. has once again demonstrated its commitment to regulatory excellence by successfully completing a surprise inspection by the USFDA. This milestone not only cements its leadership in sterile cephalosporin production but also strengthens its global credibility.

Successful USFDA Inspection with No Major Issues

Orchid Pharma Ltd. has announced the successful completion of 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, conducted between 10 and 18 February 2025, resulted in seven minor observations, none of which were related to data integrity concerns.

This development ensures that Orchid Pharma maintains its exclusive position as India’s only USFDA-approved manufacturing site for sterile cephalosporins. The facility plays a crucial role in the production of life-saving antibiotics, reinforcing the company’s global standing in the pharmaceutical industry.

Continued Global Compliance and Certification

Beyond the USFDA approval, the Alathur API facility has also secured the renewal of its European Union Good Manufacturing Practice (EU GMP) certification. This further validates Orchid Pharma’s commitment to stringent European regulatory standards, enabling the company to continue serving key international markets.

Commenting on the achievement, Manish Dhanuka, Managing Director of Orchid Pharma, stated, “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.”

Orchid Pharma Share Performance

As of February 20, 2025, at 12:43 PM, the shares of Orchid Pharma are locked in an upper circuit at ₹874.55 per share, reflecting a surge of 5% from the previous day’s closing price.

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