Natco Pharma gets 2 observations from USFDA for Vizag facility
Hyderabad: Natco Pharma Limited has announced the completion of a regulatory inspection from the United States Food and Drug Administration (USFDA) for its Formulation facility in Ramky SEZ, near Visakhapatnam (Vizag), India, which was conducted during the period 30th January, 2023 to 3rd February, 2023. At the end of the inspection, the facility received two observations, one on...
Hyderabad: Natco Pharma Limited has announced the completion of a regulatory inspection from the United States Food and Drug Administration (USFDA) for its Formulation facility in Ramky SEZ, near Visakhapatnam (Vizag), India, which was conducted during the period 30th January, 2023 to 3rd February, 2023.
At the end of the inspection, the facility received two observations, one on written production process control procedure and the other on investigation procedure.
"The Company is confident of addressing all observations within the stipulated time," Natco stated in a release.
Read also: Natco Pharma receives USFDA EIR for Vizag facility
Natco Pharma Limited is a vertically integrated and R&D-focused pharmaceutical company engaged in developing, manufacturing, and marketing of finished dosage formulations ("FDF") and active pharmaceutical ingredients ("APIs"). The company focuses primarily on niche therapeutic areas and complex products. Natco markets and distributes its products in over 40 countries.
Natco sells its FDF products in the United States, India, Europe, and the rest of the world ("RoW"). In the API segment, the company has the capabilities to develop and manufacture products with multi-step synthesis, semi-synthetic fusion technologies, high-potency APIs, and peptides.
The company has seven manufacturing facilities spread across India with modern research laboratories, capabilities in New Drug Development, etc.
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