NATCO Pharma gets USFDA nod for Everolimus tablets

NATCO's partner BPI plans to launch 0.25 mg, 0.5 mg and 0.75 mg strengths of the product shortly.

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USFDA Drug product Approval
USFDA Approval

Last Updated on December 31, 2023 by The Health Master

Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has announced that its marketing partner, Breckenridge Pharmaceutical Inc. (BPI), has received final approval for its Abbreviated New Drug Application (ANDA) for Everolimus Tablets (generic for ZORTRESS®),from the U.S. Food and Drug Administration (USFDA).

NATCO’s partner BPI plans to launch 0.25 mg, 0.5 mg and 0.75 mg strengths of the product shortly.


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The above strengths of Everolimus are indicated in the Prophylaxis of Organ Rejection in Kidney Transplantation and Liver Transplantation.

As per industry sales data, ZORTRESS® and its therapeutic equivalents had generated annual sales of $162million during the twelve months ending March 2021 in the US.

Medicine Tablets
Picture: Pixabay

Shares of NATCO PHARMA LTD. was last trading in BSE at Rs.990.8 as compared to the previous close of Rs. 932.9. The total number of shares traded during the day was 139698 in over 6426 trades.

The stock hit an intraday high of Rs. 998 and intraday low of 935. The net turnover during the day was Rs. 135789370.

All brand names and trademarks are the property of their respective owners.


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