USFDA issues 7 minor observations for Orchid Pharma Alathur facility
New Delhi: Orchid Pharma Ltd., a vertically integrated pharmaceutical company, has received seven minor observations from the U.S. Food and Drug Administration (USFDA) after the surprise inspection conducted at its Active Pharmaceutical Ingredient (API) manufacturing facility in Alathur, Tamil Nadu.
The facility was inspected from 10 February 2025 to 18 February 2025.
"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 stated.
"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," it added.
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.
Read also: DCGI nod to Orchid Pharma Antibiotic Drug Combination of Cefepime, Enmetazobactam (NCE)
Speaking on the achievement, Mr. Manish Dhanuka, Managing Director, Orchid Pharma, said,“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. As India's only USFDA approved facility for Sterile Cephalosporins, we take immense pride in maintaining this exclusive status that sets us apart in the global pharmaceutical landscape. The renewal of the EU GMP certificate further strengthens our position as a trusted pharmaceutical manufacturer for global markets.”
Read also: Orchid Pharma collaborates with Cipla to unveil antibiotic Cefepime-Enmetazobactam in India
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