Drug Approval | January 19, 2024
Zydus and Synthon inks licensing and supply agreement for Palbociclib Tablets for US market
Synthon will be responsible for obtaining US regulatory approval for Palbociclib Tablets
Synthon will be responsible for obtaining US regulatory approval for Palbociclib Tablets
This PAI-cum-GMP USFDA inspection was conducted from December 14 to December 22, 2023
Studies have demonstrated that ZYIL1 is highly potent and can suppress inflammation caused by NLRP3 inflammasome activation
The exclusive agreement also includes development, regulatory, and commercialization milestone payments based on the successful outcome
The drug will be marketed by Sun Pharma under the brand name RYTSTAT
Punit has more than 20 years of experience in the generics and branded pharmaceutical marketplace
Aim is to treat Dyslipidemia by inhibiting PCSK9 with a novel entity
Norepinephrine Bitartrate Injection is used for restoration of blood pressure in adult patients
USFDA concludes inspection at Zydus' formulation manufacturing facility at SEZ 2, Ahmedabad
The primary endpoint is to measure the change in liver stiffness measurement performed by transient elastography from Baseline to Week 52
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