Briefs: Medicamen Biotech, Aurobindo Pharma and Ajooni Biotech

The sANDA was submitted as “Prior Approval Supplement” for addition of an alternate drug product manufacturing, labeling, packaging, and testing facility

Alkem signs license agreement with Takeda to commercialise Vonoprazan in India

Vonoprazan is used in the treatment of disorders related to Gastroesophageal Reflux Disease (GERD)

Natco Pharma announces submission of TABRECTA to USFDA

TABRECTA is the brand of Novartis. Natco believes it is the first company to have filed a substantially-complete ANDA

Shilpa Medicare announces positive outcome of Phase 3 studies of NorUDCA

Nor UDCA is likely to be a first-in-class treatment option for NAFLD in India

Sun Pharma introduces STARIZO in India for skin infections

Sun Pharma has obtained rights from MSD to develop, manufacture and commercialise Tedizolid Phosphate in India

Lonza upgrades clinical manufacturing services at Bend site to include bottling and labeling capabilities

Lonza Bend (US) upgrades capabilities in early phase clinical manufacturing services with the addition of bottling and labeling equipment

Sun Pharmaceutical receives USFDA approval for oral JAK inhibitor ‘Leqselvi’

Leqselvi delivered statistically significant efficacy across two Phase 3 clinical trials

Briefs: Zydus Lifesciences and Divi's Laboratories

Zydus receives final approval from USFDA for its NDA Zituvimeta, extended-release tablets

Dr. Reddy's signs non-exclusive patent licensing agreement with Takeda to commercialise Vonoprazan

Shilpa's CDMO customer placed binding purchase order