Natco Pharma receives ANDA approval from USFDA

Natco Pharma today announced that it has received a final approval for its first supplemental abbreviated new drug application (ANDA) product from US Food & Drug Administration (USFDA) filed from its new drug formulation facility in JNPC SEZ, Ramky Pharma City, Visakhapatnam (Andhra Pradesh). 

ANDA, submitted as ‘prior approval supplement’, provides for NATCO's Visakhapatnam facility as an alternate site for the manufacture of the approved drug product for US market.

Earlier this week, the company had received a closure of inspection with an establishment inspection report (EIR) from US Food & Drug Administration (FDA) for the pre-approval inspection conducted at its drug formulations facility in Kothur village (Telangana) during the period from March 2 to March 6, 2020.

For more information, click here:

https://www.dsij.in/DSIJArticleDetail/ArtMID/10163/ArticleID/12597/USFDA-grants-EIR-to-Natco-Pharma-for-Kothur-facility

The stock of Natco Pharma reacted positively and surged to an intraday high of Rs 640.6 apiece.