Orchid Pharma Successfully Completes USFDA Inspection at Alathur API Plant

Orchid Pharma. has announced the successful completion of a surprise inspection by the U.S. Food and Drug Administration (USFDA) at its Active Pharmaceutical Ingredient (API) manufacturing facility in Alathur, Tamil Nadu.

The inspection, which began on February 10, 2025, and concluded on February 18, 2025, resulted in seven minor observations, none of which were related to data integrity.

Following this development, Orchid Pharma continues to hold its exclusive position as India’s only USFDA-approved manufacturing site for sterile cephalosporins, reinforcing its leadership in the segment.

USFDA Clearance and EU GMP Certification

The Alathur facility, known for producing life-saving cephalosporin antibiotics, remains a cornerstone of Orchid Pharma’s operations. Alongside the successful USFDA inspection, the facility has also received renewal of its European Union Good Manufacturing Practice (EU GMP) certification.

This certification strengthens Orchid Pharma’s adherence to global regulatory standards and enhances its ability to serve key international markets, ensuring the continued supply of high-quality antibiotics.

Company’s Commitment to Quality and Compliance

Manish Dhanuka, Managing Director of Orchid Pharma, emphasised the company’s commitment to maintaining global quality standards, stating “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.”

Stock Performance

On February 19, 2025, Orchid Pharma share price closed 1.99% higher at ₹834.65. The stock has seen significant fluctuations, reaching a 52-week high of ₹1,998 and a 52-week low of ₹799.75.

As per BSE data, the total traded volume for the stock stood at 0.12 lakh shares, with a turnover of ₹98.75 lakh.

At its current price, Orchid Pharma shares are trading at a price-to-earnings (P/E) ratio of 37.85x, based on its trailing 12-month earnings per share (EPS) of ₹22.05, and a price-to-book (P/B) ratio of 3.33.

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