Lupin receives tentative approval from USFDA for Selexipag for injection

This product will be manufactured at Lupin's Nagpur facility in India

NATCO Pharma announces successful completion of USFDA inspection

NATCO's Pharmacovigilance Department was inspected from October 30, 2023 to November 1, 2023

Natco Pharma receives 8 observations from USFDA for Pharma Division at Kothur

The company is confident of addressing all the observations within the stipulated time

Daiichi Sankyo, Merck collaborate to develop and commercialize three Daiichi Sankyo DXd ADCs

Merck to pay Daiichi Sankyo a $4 billion upfront payment in addition to $1.5 billion in continuation payments over the next 24 months

USFDA approves Pfizer’s Velsipity for adults with Ulcerative Colitis

Approval of oral, once-daily VELSIPITY based on favorable safety and efficacy data from the ELEVATE UC Phase 3 trials

USFDA inspection at Biocon Biologics' manufacturing facility in Johor, Malaysia

Glenmark receives ANDA approval for Apremilast Tablets

Glenmark's current portfolio consists of 188 products authorized for distribution in the US

Lupin enters into BTA with Lupin Manufacturing Solutions

Lupin enters into BTA with Lupin Manufacturing Solutions

Sirio Pharma and Best Formulations announce US gummy manufacturing capabilities

The new gummy capabilities include a dedicated R&D lab, an automated production line, and bottle packaging solutions

Dr Reddy's Bachupally biologics facility gets USFDA Form 483 with 9 observations

The USFDA inspectors issued the observations after a product pre-approval inspection of the biologics facility in Bachupally