Orchid Pharma Clears USFDA Inspection, Secures EU GMP Renewal

20 Feb 2025 , 03:36 PM

Orchid Pharma Ltd has successfully cleared a surprise inspection by the U.S. Food and Drug Administration (USFDA) at its Active Pharmaceutical Ingredient (API) manufacturing plant at Alathur in Tamil Nadu. The inspection was conducted from February 10, 2025, to February 18, 2025.

The inspection raised, seven minor observations none related to data integrity, and therefore, the facility remains compliant under stringent regulatory standards. With this endorsement, Orchid Pharma remains the sole USFDA approved sterile cephalosporins drug manufacturing site in India, affirming India’s leadership in the global pharmaceutical space.

Cephalosporin antibiotics produced at the Alathur facility are essential for saving lives and account for discharge of cefalosporin antibiotics for the domestic and international market.

Additionally, the site was reissued its European Union Good Manufacturing Practice (EU GMP) certification, highlighting its commitment to maintaining stringent European pharmaceutical manufacturing standards.

Acquisition of the EU GMP certification facilitates Orchid Pharma to service its products to the global key markets and create a healthy international portfolio in perpetuity. The company is dedicated to maintaining the highest quality and regulatory standards while supporting smooth global business operations.

According to Manish Dhanuka, Managing Director of Orchid Pharma, the successful closure of the USFDA audit is an acknowledgment of the company’s commitment to quality standards, compliance, and adherence to global regulations.

Teams at the company are working day and night to keep best-in-class manufacturing practices ongoing, and a steady state of-class of antibiotics flowing to markets around the world.