Orchid Pharma’s Regulatory Victory: Alathur Plant Earns USFDA Seal of Approval!

Orchid Pharma Ltd has successfully received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) following a surprise inspection at its Active Pharmaceutical Ingredient (API) manufacturing facility in Alathur, Tamil Nadu. The inspection, conducted from February 10 to 18, 2025, resulted in seven minor observations, none related to data integrity—affirming Orchid Pharma’s robust compliance with global regulatory standards.

 

Key Highlights:

 

USFDA Clean Chit: The Alathur facility’s inspection concluded with only seven minor observations, all of which are considered non-critical and unrelated to data integrity. This outcome ensures uninterrupted operations and continued exports to the US market.

 

Exclusive Status Maintained: Orchid Pharma remains India’s only USFDA-approved manufacturing site for sterile cephalosporins, a critical class of life-saving antibiotics. The successful inspection further cements its leadership in this segment and reinforces its reputation for manufacturing excellence.

 

Global Regulatory Strength: Alongside the USFDA EIR, the Alathur facility also secured renewal of its European Union Good Manufacturing Practice (EU GMP) certificate after a successful inspection, validating its capability to serve both US and European markets.

 

Leadership Commentary: Managing Director Manish Dhanuka praised the team’s commitment to quality and compliance, emphasizing that these regulatory milestones underline Orchid Pharma’s dedication to delivering world-class antibiotics globally.

 

Market Reaction: Shares of Orchid Pharma responded positively, ending 1.2% higher at ₹828.25 on the BSE, reflecting investor confidence in the company’s regulatory standing and growth prospects.

 

With these achievements, Orchid Pharma is well-positioned to continue its supply of high-quality antibiotics to international markets, reinforcing its status as a trusted global pharmaceutical manufacturer.

 

Sources: Business Standard, Medical Dialogues, Angel One, CNBC-TV18, Pharmabiz