Natco Pharma has received 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 manufacture of the approved drug product for the US market.
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