Orchid Pharma hits 5% upper circuit after USFDA inspection at TN facility

Orchid Pharma shares were locked in a 5 per cent upper circuit in Thursday's trade on BSE at Rs 876.35 per share. The buying on the counter came after the United States Foods and Drugs Administration (US FDA) completed inspecting the company's manufacturing facility in Alathur, Tamil Nadu.

 

Around 11:15 AM, Orchid Pharma share price was up 5 per cent at Rs 876.35 per share on BSE. In comparison, the BSE Sensex was down 0.21 per cent at 75,777.97. The market capitalisation of the company stood at Rs 4,444.77 crore. The 52-week high of the stock was at Rs 1,998 per share and the 52-week low was at Rs 799.75 per share.

 

 

The US FDA conducted an inspection at Orchid Pharma's Active Pharmaceutical Ingredient (API) manufacturing facility in Alathur, Tamil Nadu. The inspection commenced on February 10, 2025, and concluded on February 18, 2025, resulting in seven minor observations, none of which pertain to the data integrity of the facility.

 

Even after the observations, the facility still held the position as India's only US FDA-approved facility for Sterile Cephalosporins. The Alathur facility specialises in the production of Cephalosporin antibiotics, a critical class of life-saving drugs, as per the filing. 

 

"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," said Manish Dhanuka, managing director, Orchid Pharma.

 

He added: As India's only US FDA 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.

 

Established in 1992 as an export-oriented unit (EOU), Orchid Pharma spans the entire pharmaceutical value chain with established credentials in research, manufacturing, and marketing. Orchid, is the only Indian pharmaceutical company, to have invented a New Chemical Entity (NCE, also colloquially called New Drug). The molecule is out-licensed (on Royalty model) and is now approved in the US and Europe.

 

In the past one year, Orchid Pharma shares have lost 24.3 per cent against Sensex's rise of 4 per cent.