Briefs: Alembic Pharmaceuticals and Tyche Industries
Alembic receives EIR from USFDA for facility at Panelav
Alembic receives EIR from USFDA for facility at Panelav
The U.S. FDA issued a Form 483 with five observations
The inspection concluded with NIL observations
This facility is capable of manufacturing, packaging, testing, storage and distribution of two types of complex dosage forms
This was a full GMP inspection of the entire facility with specific focus on Ondansetron Oral Film drug product
The audit has been concluded with no major observations
Shilpa Pharma Lifesciences, Unit-1, received EIR from USFDA
Alembic Pharmaceuticals successfully completes USFDA inspection for API-III facility
Cipla Limited has received final approval from the USFDA for the New Drug Application submitted for ‘Nilotinib Capsules 50, 150 and 200 mg’
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