Zydus receives final approval from USFDA for Paliperidone ER Tablets, 1.5 mg, 3 mg, 6 mg, and 9 mg
Paliperidone extended-release tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad
Paliperidone extended-release tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad
Approval is based on Phase III INAVO120 results, showing the Itovebi (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting
Mylan and Novo Nordisk reach settlement of US patent litigation related to Ozempic
Enzalutamide Tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad
Gilead Sciences first launched Lenacapavir under the brand name Sunlenca in the United States and Europe markets in the year 2022
The observations are of procedural in nature and will be responded to within the stipulated time
HSGP is engaged closely with the USFDA and is committed to address the OAI observations through planned remediation measures
Enzalutamide Capsules will be produced at the Group’s manufacturing site at Moraiya, Ahmedabad
Glenmark Pharmaceuticals Limited has informed that the USFDA has issued Form 483 with zero observations
Bumetanide Injection USP (RLD Bumex) had estimated annual sales of USD 20 million in the U.S.
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