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Drug Approval | April 14, 2024
Granules India’s Unit V facility in Visakhapatnam completes USFDA inspection with zero 483 observations
This facility manufactures APIs & formulations of oncology and non-oncology products.
This facility manufactures APIs & formulations of oncology and non-oncology products.
The inspection was conducted from April 8 to April 12, 2024 and concluded with no observations
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Prozac Tablets of Eli Lilly
The company will respond to the Warning Letter within the stipulated timelines
These observations are procedural in nature and will be responded within the stipulated time
The observations are procedural in nature and will be responded to within the stipulated time
The Product is expected to be the first generic approval on the market
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The regulator carried out a routine current Good Manufacturing Practices (cGMP) inspection from March 28 to April 4.
Abecma tripled progression-free survival compared to standard regimens in the Phase 3 KarMMa-3 trial
For the treatment of stenotic lesions of arteriovenous fistula in the haemodialysis management of chronic renal failure
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