The company had submitted a comprehensive Corrective and Preventive Action (CAPA) plan in September 2022
Tolvaptan Tablets (RLD Jynarque) had estimated annual sales of USD 287 million in the U.S. (IQVIA MAT August 2023)
The extension builds upon an existing long-term collaboration for end-to-end ADC manufacturing, including payload, monoclonal antibody (mAb) manufacturing and bioconjugation
This product is bioequivalent to the reference listed drug (RLD), Nexium 24 HR Delayed- Release Capsules, 2.0mg (OTC), of AstraZeneca Pharmaceuticals
The approval adds to a list of products that Strides has approved in this therapeutic category through the PEPFAR pathway taking the total to 15 products
The company has received six final approvals that includes Chlorpromazine Hydrochloride Tablets
SigTuple’s AI100 with Shonit is the premier solution for AI assisted digital pathology
Diofan Ultra736 provides ultra-high water vapor barrier with excellent thermoformability, unlocking the potential to design thinner and more sustainable blister films
The delegation's visit covered a wide range of topics
Glenmark will receive from Cassiopea, a subsidiary of Cosmo, the exclusive right to commercialize Winlevi in 15 EU countries
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