Zydus Lifesciences’ API Unit Approved by USFDA

On Thursday, March 7, 2024, Zydus Lifesciences Ltd’s Ahmedabad facility got a positive “post-application action letter” from the United States Food and Drug Administration (USFDA). The US FDA inspected their API unit, and in the letter, they indicated that the company’s API unit is ready for commercial production.

US Food and Drug Administration Inspection Details

The US Food and Drug Administration inspected Zydus Lifesciences Ltd’s Ahmedabad unit from December 14 to December 22, 2023.

In December 2023, the company informed in the exchange filing that the inspection encompassed Pre-Approval Inspection (PAI) and Good Manufacturing Practices (GMP). It concluded with the issuance of six observations.

The company informed the stock exchanges in a filing that the US Food and Drug Administration inspection covered for-cause current Good Manufacturing Practices (cGMP) surveillance and pre-approval inspection for Enzalutamide, which is a medication used to treat prostate cancer.

Zydus Lifesciences stated that obtaining a positive post-application action letter from the United States drug regulator confirms that the inspected facility has been considered ready to manufacture and supply the Enzalutamide API commercially”.

In January 2024, the drug firm Zydus Lifesciences disclosed that its wholly-owned subsidiary secured an exclusive licensing and supply arrangement with Synthon for Palbociclib Tablets aimed at the US market. Given that Synthon was the initial and sole Abbreviated New Drug Application (ANDA) filer for Palbociclib Tablets in strengths of 75 mg, 100 mg, and 125 mg. This has to be accompanied by a paragraph IV certification, and it could potentially qualify for 180 days of exclusivity for generic drug distribution across all 3 strengths.

In December 2023, Zydus Lifesciences also announced it got approval from the US health regulator to market a generic product targeting a rare blood condition.

Post the inspection letter news on March 7, 2024, the shares of Zydus Lifesciences rose about 2.08% to their 52-week high of ₹982.1 per share on BSE. At 1.33 PM, Zydus Lifesciences Ltd’s shares were trading 1.22% higher at ₹973.80 per share on the BSE.

About Zydus Lifesciences Ltd

Zydus Lifesciences Ltd is engaged in the business of research and development, manufacturing, marketing, and distribution of pharmaceutical products. The company serves their products all over the country and 81 countries in the world.

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