Anuh Pharma Ltd’s manufacturing facility at Tarapur MIDC in Maharashtra has successfully completed a United States Food and Drug Administration (USFDA) inspection with no Form 483 observations.
The outcome, disclosed in a regulatory filing, underscores the company’s adherence to global regulatory and quality standards.
Established in 1960, Anuh Pharma is a BSE- and NSE-listed company and among India’s largest manufacturers of Macrolides and anti-tuberculosis products. The company also produces anti-bacterials, anti-malarials, anti-hypertension drugs, and corticosteroids.
The Tarapur manufacturing site spans 11,400 square metres, including a newly acquired 7,800-square-metre plot. It comprises nine API manufacturing blocks and two intermediate blocks, with a total production capacity of 2,400 metric tonnes per annum (MTPA). The facility is already approved under EU-GMP and WHO prequalification standards.
Anuh Pharma also operates a dedicated research and development centre in Mahape, Navi Mumbai, covering 10,000 square feet, supporting the company’s development and innovation activities.
Financially, Anuh Pharma reported strong growth for the quarter ended October–December 2025. Net profit stood at Rs 13.90 crore, reflecting a 34.4% year-on-year increase and an 80.7% rise over the preceding quarter. Total revenue reached Rs 201.29 crore, marking a 25.5% increase compared to the same quarter last year and a 7.7% sequential growth from the previous quarter.
The successful USFDA inspection, combined with robust financial performance, reinforces Anuh Pharma’s position as a compliant and rapidly growing player in the Indian pharmaceutical sector.
