The inspection, which is a routine part of the FDA's regulatory oversight, evaluates compliance with Good Manufacturing Practices and other regulatory requirements.
This facility is considered to be in a minimally acceptable state of compliance with regard to current GMP
FDC Ltd has received final approval from USFDA for the company's Abbreviated New Drug Application (ANDA) for Cefixime 400 mg Tablets
If approved, Blenrep (belantamab mafodotin) in combinations with BorDex (BVd) and PomDex (BPd) could redefine multiple myeloma treatment at or after first relapse
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
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