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1013 News Found

Shilpa Medicare Unit IV, Jadcherla has cleared TGA, Australia GMP inspection
Drug Approval | October 18, 2023

Shilpa Medicare Unit IV, Jadcherla has cleared TGA, Australia GMP inspection

This inspection is the fourth major regulatory inspection (after Russia, Canada and Brazil), cleared by this site in the past two years


Glenmark receives ANDA approval for Apremilast Tablets
Drug Approval | October 18, 2023

Glenmark receives ANDA approval for Apremilast Tablets

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


Ipca appoints Hitesh Kumar Maheshwari as President – R&D (Formulations)
People | October 16, 2023

Ipca appoints Hitesh Kumar Maheshwari as President – R&D (Formulations)

He will be responsible for leading all the activities related to the Research & Development (Formulations) Division of the company


Zydus appoints Punit Patel as President and CEO, Americas
People | October 16, 2023

Zydus appoints Punit Patel as President and CEO, Americas

Punit has more than 20 years of experience in the generics and branded pharmaceutical marketplace


Evonik and Shandong Vland Biotech form JV in China with focus on gut health products for animals
News | October 14, 2023

Evonik and Shandong Vland Biotech form JV in China with focus on gut health products for animals

Evonik China and Shandong Vland Biotech agreed to build a joint venture to expand their presence in gut health solutions products for farm animals globally


Sun Pharma gets USFDA filing acceptance of new drug application for Deuruxolitinib
Drug Approval | October 09, 2023

Sun Pharma gets USFDA filing acceptance of new drug application for Deuruxolitinib

The NDA filing for deuruxolitinib with the U.S. FDA is based on two pivotal Phase III trials


Biocon signs commercialization agreement with Juno Pharmaceuticals in Canada
News | October 09, 2023

Biocon signs commercialization agreement with Juno Pharmaceuticals in Canada

Biocon will be responsible for obtaining regulatory approval for Liraglutide, and thereafter, for the manufacture and supply of the product in the Canadian market


Mitsui invests in Lokavant Holdings
News | October 09, 2023

Mitsui invests in Lokavant Holdings

Lokavant provides clinical trial intelligence


Lupin receives tentative approval from USFDA for Tolvaptan Tablets
Drug Approval | October 07, 2023

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)


Asahi Kasei Pharma files application for approval to manufacture and sell Cresemba Capsule
Drug Approval | October 05, 2023

Asahi Kasei Pharma files application for approval to manufacture and sell Cresemba Capsule

The product is an additional formulation of Cresemba Capsule 100 mg and Cresemba Intravenous Infusion 200 mg