Orchid Pharma gains as U.S.FDA completes Tamil Nadu facility inspection

Orchid Pharma added 1.96% to Rs 851 after company completed an 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 February and 18 February, resulted in seven minor observations but did not raise concerns about data integrity, the company said in a regulatory filing after market hours on Wednesday.

Orchid Pharmas Alathur facility remains Indias only USFDA-approved manufacturing site for sterile cephalosporins, a class of antibiotics used to treat bacterial infections.

The company also announced that the facility has secured the renewal of its European Union Good Manufacturing Practice (EU GMP) certification, reinforcing compliance with European standards and enhancing its ability to serve key international markets.

 

Manish Dhanuka, MD, 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.

Orchid Pharma is one of the leading pharmaceutical companies in India, headquartered in Chennai, and involved in the development, manufacture, and marketing of diverse bulk actives, formulations, and nutraceuticals, with exports spanning over 40 countries.

The pharma companys consolidated net profit tumbled 29.4% to Rs 20.78 crore in Q3 FY25 as compared with Rs 29.43 crore in Q3 FY24. Income from operations shed 1.5% YoY to Rs 217.34 crore in the quarter ended 31 December 2024.

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