USFDA Completes Inspection of Anuh Pharma’s Facilities Without Form 483 Observation

Mumbai, February 9: US drug regulator has completed its inspection of Anuh Pharma Ltd’s manufacturing facilities located at Tarapur MIDC in Maharashtra.

The inspection was completed with no Form 483 observations issued, the company informed in its regulatory filing with the stock exchanges.

The successful outcome of the inspection reaffirms the Company’s continued adherence to global regulatory and quality compliance standards, the filing said.

Established in 1960, BSE-NSE listed Anuh Pharma is one of the largest manufacturers of Macrolides and Anti-TB products in India, besides being a major player in Anti-bacterials, Anti-malarial, Anti-hypertension and Corticosteroids at its Tarapur facility spread over 11,400 square meters including newly acquired plot of 7,800 square meters.

The company also has a R&D facility at Mahape in Navi Mumbai spread over 10,000 square feet.

The Tarapur facility is already a EUGMP/ WHO Pre qualified approved manufacturing facility with 9 API’s blocks and 2 intermediate block with total capacity of 2400 MTPA.

On Friday, the company reported a net profit of Rs 13.90 crore for its recently concluded quarter of Oct-Dec, up 34.4 percent from the same quarter last year and up 80.7 percent from the sequential preceding quarter of Jul-Sep, as per the filing by the company with the exchanges.

Total revenue of the bulk drug company for the third quarter of the financial year 2025-26 stood at Rs 201.29 crore, up 25.5 percent from the same quarter last year and up 7.7 percent from the sequential preceding quarter.