Natco Pharma has received the final approval from US Food and Drug Administration (USFDA) for the first supplemental abbreviated new drug application (sANDA) product filed from the company’s new drug formulations facility in JNPC SEZ, Ramky Pharma City, Visakhapatnam.
The sANDA, submitted as “Prior Approval Supplement,” provides for the Visakhapatnam facility as an alternate site for manufacture of the approved drug product for the U.S. market, Natco Pharma said on Tuesday.
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