News | June 03, 2026
Granules Pharmaceuticals receives USFDA EIR for Chantilly facility
This facility plays an important role in Granules’ global manufacturing and supply network
This facility plays an important role in Granules’ global manufacturing and supply network
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
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