Drug Approval | November 10, 2024
Granules India’s Unit V facility secures USFDA EIR with NAI status
The FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit
The FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit
Revenue share from the North America increased to 79% in Q2 FY25 as compared to 67% in Q2 FY24
Granules now has a total of 67 ANDA approvals from the USFDA
Aims to achieve CDMO sales of US$ 400 million by 2028
The observations are of procedural in nature and will be responded to within the stipulated time
Lupin's Pithampur Unit-1 gets Form 483 from USFDA with 3 observations
Eugia Steriles receives EIR from USFDA for new injectable facility
The recent inspection covered both cGMP and PAI processes
Trazodone tablets are indicated for the treatment of major depressive disorder in adults
Decision on EU marketing authorisation for this population expected by September 2024
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