This product has only one approved generic and one authorized generic with an addressable market share of US$ 172 million
Granules Pharmaceuticals gets 5 observations from USFDA on completion of GMP inspection
The inspection was conducted at Granules Pharmaceuticals Inc. (GPI) from July 31, 2023 to August 03, 2023
Granules now have a total of 53 ANDA approvals from USFDA
This is the sixth successful USFDA audit for this facility
The audit is a PAI for two of its product applications filed from this facility
India is dependent upon China and other countries for a lot of Key Starting Materials (KSM) for their bulk drug needs.
Tablets will be manufactured at Granules' US-based facility located in Chantilly, Virginia
Granules Consumer Health serves as Granules’ front-end division for OTC products in the US
Granules India receives 1 observation from USFDA for Chantilly facility
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