Last Updated on October 10, 2024 by The Health Master
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 Special Economic Zone (SEZ), near Visakhapatnam (Vizag), India, which was conducted from January 30th, 2023, to February 3rd, 2023.
Two observations were made about the facility’s written production process control procedure and investigation procedure at the conclusion of the inspection.
Natco Pharma Limited is a vertically integrated and R&D-focused pharmaceutical company engaged in the development, 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 market and distribute 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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