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)

Marksans Pharma gets USFDA approval for Esomeprazole Magnesium delayed-release capsules

This product is bioequivalent to the reference listed drug (RLD), Nexium 24 HR Delayed- Release Capsules, 2.0mg (OTC), of AstraZeneca Pharmaceuticals

Strides receives USFDA approval for Efavirenz, Emtricitabine & Tenofovir Disoproxil Fumurate tablets

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

Alembic received 6 USFDA approvals during Q2FY24

The company has received six final approvals that includes Chlorpromazine Hydrochloride Tablets

Strides receives USFDA approval for Icosapent Ethyl capsules

The product is bioequivalent and therapeutically equivalent to the RLD, Vascepa of Amarin

SigTuple’s AI100 with Shonit receives USFDA 510(k) clearance

SigTuple’s AI100 with Shonit is the premier solution for AI assisted digital pathology

USFDA delegation visits Divi's Laboratories’ Unit I at Choutuppal, Telangana

The delegation's visit covered a wide range of topics

USFDA inspection at Piramal Pharma’s Bethlehem facility

Strides receives USFDA approval for Icosapent Ethyl Capsules

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD)

Zydus receives final approval from the USFDA for Clindamycin Phosphate Gel USP, 1%

Clindamycin Phosphate Gel is used to treat acne