In a significant development for the pharmaceutical industry, Zydus Lifesciences has received clearance from the US Food and Drug Administration (USFDA) for the commercial manufacture and supply of active pharmaceutical ingredients (APIs). This clearance follows a thorough inspection conducted by the US drug regulator at Zydus’ manufacturing facility in Ahmedabad between December 14 and 22.

The inspection, focused on good manufacturing practices (cGMP) surveillance and pre-approval inspection for Enzalutamide, a crucial drug used in the treatment of prostate cancer, has culminated in a positive outcome for Zydus Lifesciences. The company confirmed the receipt of the Post Application Action Letter from USFDA, indicating that the inspected facility is deemed ready for commercial production and supply of the API.

Although Zydus received six observations for the plant during the inspection, the company swiftly assured its commitment to working closely with the USFDA to address these observations. Importantly, there were no observations related to data integrity, underscoring the company’s dedication to maintaining high standards of quality and compliance.

This clearance marks a significant milestone for Zydus Lifesciences, affirming its capabilities in API manufacturing and its commitment to delivering high-quality pharmaceutical products to patients in need. With the clearance secured, Zydus is poised to play a crucial role in meeting the demand for Enzalutamide, thereby contributing to the fight against prostate cancer on a global scale.

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