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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.
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
For the treatment of stenotic lesions of arteriovenous fistula in the haemodialysis management of chronic renal failure
The facility will manufacture tablets, capsules, and injections for the oncology segment
The inspection at Unit 1 by the USFDA has been successfully completed, with no observations under Form 483
New facility includes 20KL of single use drug substance capacity coupled with drug product filling capacity of up to one million vials per day
It is the first autotaxin inhibitor to be investigated in cancer patients
The inspection was concluded with few procedural observations
The company will provide comprehensive response to USFDA for the observations
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