Natco Pharma marketing partner gets USFDA approval for Everolimus tablets

Published On 2021-05-23 06:00 GMT   |   Update On 2021-05-23 06:00 GMT

Hyderabad: Drugmaker, Natco Pharma Limited, has recently announced that the company's 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...

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Hyderabad: Drugmaker, Natco Pharma Limited, has recently announced that the company's 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.

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.

Read also: Natco Pharma Lenalidomide Capsules secures USFDA okay

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




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