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.
This approval is backed by a decade of proven safety and efficacy data of Ocrevus® IV, with over 350,000 people treated globally
Eugia Steriles receives EIR from USFDA for new injectable facility
Mirabegron Extended-Release Tablets, 50 mg is a generic equivalent of Myrbetriq® Extended-Release Tablets, 50 mg of Astellas Pharma Global Development
ForDoz Pharma Corporation, USA (ForDoz) received an approval for its ANDA from the USFDA
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