Orchid Pharma Limited has announced the successful completion of a surprise USFDA inspection at its Active Pharmaceutical Ingredient (API) manufacturing facility in Alathur, Tamil Nadu. The inspection, conducted between February 10-18, 2025, resulted in seven minor observations, none of which were related to data integrity concerns. With this, Orchid Pharma continues to hold its distinction as India’s only USFDA-approved facility for Sterile Cephalosporins.
Additionally, the company secured the renewal of its EU Good Manufacturing Practice (GMP) certification, further strengthening its compliance with European regulatory standards. This positions Orchid Pharma as a trusted global supplier of high-quality Cephalosporin antibiotics, a crucial class of life-saving drugs.
Managing Director’s statement
Speaking on the achievement, Manish Dhanuka, Managing Director of Orchid Pharma, said:
“The successful completion of the USFDA inspection underscores our unwavering commitment to quality, compliance, and global regulatory standards. As India’s only USFDA-approved facility for Sterile Cephalosporins, we take immense pride in maintaining this exclusive status, which 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.”
About Orchid Pharma
Founded in 1992, Orchid Pharma is a vertically integrated pharmaceutical company involved in research, manufacturing, and marketing. It is recognized as the only Indian pharmaceutical company to have ever invented a New Chemical Entity (NCE), which is licensed under a royalty model and approved in the US and Europe. The company is a leader in Cephalosporin production, with its Alathur facility being one of only three USFDA-approved sites for Sterile Cephalosporins worldwide.
With these regulatory milestones, Orchid Pharma reaffirms its commitment to global quality standards, ensuring a continuous supply of high-quality antibiotics to key international markets.
