Drug Approval | October 19, 2024
Granules India receives ANDA approval for Bupropion Hydrochloride ER Tablets
Granules now has a total of 67 ANDA approvals from the USFDA
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
The inspection was concluded with two 483 observations
Rusan’s API facility in Ankleshwar is GMP approved by other stringent international agencies as well
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