Granules clears US FDA audit
The US FDA has closed the observations pertaining to this audit with an Establishment Inspection Report on the 20th of July 2021
The US FDA has closed the observations pertaining to this audit with an Establishment Inspection Report on the 20th of July 2021
The company is exploring all legal options to challenge the award.
NATCO and Arrow shall launch the product on agreed-upon launch dates in the future.
The INVANZ brand and generic market had U.S. sales of approximately US $205 million MAT for the most recent twelve months ending March 2021 according to IQVIA Health
Dr. Reddy’s Albendazole Tablets, USP are available in 200 mg tablets in bottle count sizes of two
Sapropterin dihydrochloride powder for oral solution is available in 100 mg unit dose
Zydus has made its brand of Remdesivir, Remdac more affordable at Rs. 899 for a 100 mg lyophilized injection.
NATCO's partner BPI plans to launch 2.5 mg, 5 mg and 7.5 mg strengths of the product shortly within the next few weeks.
The company will review FDA's response and decide on appropriate next steps soon.
Fluphenazine Hydrochloride Tablets, USP are available in 1 mg, 2.5 mg, 5 mg, and 10 mg tablets in 100 bottle count sizes.
Subscribe To Our Newsletter & Stay Updated