Drug Approval | October 07, 2023
Lupin receives tentative approval from USFDA for Tolvaptan Tablets
Tolvaptan Tablets (RLD Jynarque) had estimated annual sales of USD 287 million in the U.S. (IQVIA MAT August 2023)
Tolvaptan Tablets (RLD Jynarque) had estimated annual sales of USD 287 million in the U.S. (IQVIA MAT August 2023)
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
The product is bioequivalent and therapeutically equivalent to the RLD, Vascepa of Amarin
Balaxi Healthcare Ecuador S.A.S. has become a Wholly Owned Subsidiary of the company
Diofan Ultra736 provides ultra-high water vapor barrier with excellent thermoformability, unlocking the potential to design thinner and more sustainable blister films
The U.S. FDA has determined that the inspection classification of the facility is Voluntary Action Indicated
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
Subscribe To Our Newsletter & Stay Updated
