US FDA completes inspection of Anuh Pharma’s Tarapur manufacturing facility
Inspection concluded with no Form 483 observations, company informs stock exchanges
The US drug regulator has completed an inspection of Anuh Pharma’s manufacturing facilities located at Tarapur MIDC in Maharashtra, according to a regulatory filing by the company with the stock exchanges.
The company stated that the inspection was completed with no Form 483 observations issued by the regulator.
In its filing, Anuh Pharma said that the outcome of the inspection reaffirms the company’s continued adherence to regulatory and quality compliance standards.
Established in 1960, BSE-NSE listed Anuh Pharma is a manufacturer of macrolides and anti-TB products in India. The company also operates in anti-bacterials, anti-malarial, anti-hypertension and corticosteroids. Its Tarapur manufacturing facility spans 11,400 square metres, including a newly acquired plot of 7,800 square metres.
Anuh Pharma also operates a research and development facility at Mahape in Navi Mumbai, covering an area of 10,000 square feet.
The Tarapur facility holds EUGMP and WHO pre-qualification approvals and includes nine API blocks and two intermediate blocks, with a total production capacity of 2,400 metric tonnes per annum.
In a separate filing on Friday evening, the company reported a net profit of ₹13.90 crore for the October–December quarter. This represents an increase of 34.4 per cent compared to the same quarter last year and an increase of 80.7 per cent compared to the preceding July–September quarter.
Total revenue for the third quarter of the financial year 2025–26 stood at ₹201.29 crore, reflecting an increase of 25.5 per cent year-on-year and 7.7 per cent on a sequential basis, as per the company’s filing.