USFDA inspection of Lupin’s Nagpur injectable facility with zero 483 observations

Indoco Remedies receives tentative ANDA approval for Canagliflozin, Metformin Hydrochloride Tablets

Canagliflozin and Metformin Hydrochloride Tablets are used to treat type 2 diabetes mellitus

Bristol Myers Squibb announces Opdivo Plus Yervoy (ipilimumab) improved overall survival for patients with unresectable hepatocellular carcinoma

Dual immunotherapy combination of Opdivo plus Yervoy demonstrated improved survival benefit compared to lenvatinib or sorafenib in this patient population

Alembic Pharmaceuticals receives USFDA final approval for Sacubitril and Valsartan Tablets

Sacubitril and Valsartan Tablets are indicated to reduce the risk of cardiovascular death

Zydus receives final approval from USFDA for Theophylline ER Tablets

Theophylline is used to treat asthma and chronic obstructive pulmonary disease

Zydus receives final approval from USFDA for Dexamethasone Tablets

Dexamethasone Tablets USP, 1 mg had annual sales of US$ 1.8 mn in the United States (IQVIA MAT March 24)

Strides receives USFDA approval for Sevelamer Carbonate Tablets

Sevelamer Carbonate Tablets approval consolidates the company's position in the Sevelamer segment

Lonza launches AI-enabled Route Scouting Service to accelerate small molecule development

New advanced technology-enabled offering aims to streamline synthetic route identification for novel active pharmaceutical ingredients (APIs)

Glenmark receives ANDA approval for acetaminophen and ibuprofen tablets

Glenmark’s Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC), will be distributed in the U.S. by Glenmark Therapeutics, USA

Zydus Lifesciences gets 10 observations from USFDA for Jarod injectable facility

The company will closely work with the USFDA to address and respond to the observations in an expeditious manner