NATCO Pharma's Visakhapatnam Plant Gets 4 USFDA Observations
Hyderabad: NATCO Pharma Limited has announced the conclusion of a US Food and Drug Administration (USFDA) inspection at its Finished Dosage Formulations (FDF) manufacturing unit in Parawada, Visakhapatnam, Andhra Pradesh, with the company receiving a Form 483 containing four observations. NATCO Pharma stated that it believes the observations are procedural in nature and is confident of addressing them comprehensively within the stipulated timelines.
NATCO Pharma informed the stock exchanges that the US FDA had conducted an inspection at the company's FDF manufacturing plant located in Parawada, Visakhapatnam, Andhra Pradesh, India. The inspection was conducted from August 17 to August 21, 2026.
Upon completion of the inspection, the company was issued Form 483 with four observations. NATCO Pharma said that it believes the observations are procedural in nature and expressed confidence that it will address the observations comprehensively within the stipulated timelines.
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NATCO Pharma, headquartered in Hyderabad, is engaged in the development, manufacture and distribution of generic and branded pharmaceuticals, specialty pharmaceuticals, active pharmaceutical ingredients and crop protection products. The company describes itself as R&D-oriented and science-driven, and as a leading oncology player in targeted therapies in the domestic market, while focusing on molecules with limited competition in the US.
NATCO Pharma further stated that its manufacturing facilities are approved by several leading regulatory authorities, including the US FDA, Brazil ANVISA, Health Canada and WHO, among others, and that these facilities cater to more than 50 global markets.
