Jubilant’s Radiopharma business receives NDA approval for Technetium Mertiatide Injection

The Tc 99m Mertiatide Injection is used in the diagnosis of congenital and acquired renal abnormalities

Granules Pharmaceuticals receives ANDA approval for amphetamine mixed salts ER capsules

Granules now have a total of 53 ANDA approvals from USFDA

SK bioscience appoints new executives

Two biopharmaceutical experts join SK bioscience to strengthen the future strategies

US FDA accepts supplemental new drug application for Jardiance for adults with chronic kidney disease

The supplemental New Drug Application is based on results from the landmark EMPA-KIDNEY phase III trial

Zydus receives tentative approval from USFDA for Levomilnacipran Extended-Release Capsules

The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad, India

Lupin receives approval from USFDA for Prasugrel Tablets, USP

Lupin receives approval from USFDA for Fesoterodine Fumarate Extended-Release Tablets

Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg, (RLD Toviaz®) had estimated annual sales of USD 177 million in the U.S. (IQVIA MAT September 2022).

Zydus launches Topiramate Extended-Release Capsules

Zydus is the first company to receive final approval and launch Topiramate Extended-Release Capsules, USP 25 mg, 50 mg, and 100 mg in the United States.

Alembic receives USFDA final approval for Fesoterodine Fumarate Extended-Release Tablets

Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg, have an estimated market size of US$ 177 million for twelve months ending Sep 2022

Provention Bio appoints Rita Jain to Board of Directors

Dr. Jain is a biotechnology industry veteran with more than two decades of experience in pharmaceutical development across her time with ChemoCentryx, AbbVie, Abbott Laboratories, and G.D. Searle and Co