Drug Approval | January 03, 2024
Alembic Pharmaceuticals received 8 USFDA approvals in Q3FY24
The company has received five final approvals
The company has received five final approvals
Vyleesi is the first and only as-needed treatment approved by the Food and Drug Administration (FDA) for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD)
Development services for gene and cell therapies is planned to begin first in 2025
Granules Pharmaceuticals gets 5 observations from USFDA on completion of GMP inspection
Laurus Synthesis receives Form 483 with 5 observations from USFDA
The exclusive agreement also includes development, regulatory, and commercialization milestone payments based on the successful outcome
Dr. Reddy's Laboratories has been issued a Form 483 with three observations
The agreement includes an upfront payment of US$15 million, regulatory and commercial milestones, and royalties
Prior to joining Alembic, he was working with Lupin Limited for more than 11 years
EBITDA for Q2 FY24 at Rs. 71.2 crore as compared to Rs. 79.9 crore QoQ
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