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US FDA Clears Anuh Pharma Facility with No Form 483 Observations

US FDA Clears Anuh Pharma Facility with No Form 483 Observations

The US Food and Drug Administration (FDA) has completed its inspection of Anuh Pharma’s manufacturing facilities located at Tarapur Maharashtra Industrial Development Corporation (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 outcome of the inspection reaffirms the company’s continued adherence to global regulatory and quality compliance standards, the filing said.

The Tarapur facility is already an EUGMP/ WHO pre-qualified approved manufacturing facility with nine API’s blocks and two intermediate blocks with total capacity of 2400 MTPA.

Established in 1960, the company 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 metres, including newly acquired plot of 7,800 square metres.

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

Recently, the company reported a net profit of INR 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 INR 201.29 crore, up 25.5 percent from the same quarter last year and up 7.7 percent from the sequential preceding quarter.

More news about: quality / gmp | Published by News Bureau | February - 11 - 2026 | 157

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