Natco Pharma gets USFDA nod for Vizag Formulation Facility
Hyderabad: Natco Pharma Limited has announced the final approval of its 1st supplemental abbreviated new drug application (sANDA) product from the U.S. Food and Drug Administration (USFDA) filed from its new drug formulations facility in JNPC SEZ, Ramky Pharma City, Visakhapatnam (Vizag), Andhra Pradesh, India.
The sANDA, submitted as "Prior Approval Supplement," provides for NATCO' s Vizag facility as an alternate site for the manufacture of the approved drug product for the US market.
Natco Pharma Limited was incorporated in Hyderabad in the year 1981 with an initial investment of INR 3.3 million.
The Company has seven manufacturing facilities spread across India with modern research laboratories, capabilities in New Drug Development, etc.