Drug Approval | December 12, 2022
Zydus receives USFDA approval to market Silodosin and Pregabalin capsules
Silodosin capsules treat signs and symptoms of an enlarged prostate gland
Silodosin capsules treat signs and symptoms of an enlarged prostate gland
Soluplus branded excipient play a critical role in enabling the drug development process for poorly soluble active pharmaceutical ingredients
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad
Diclofenac Sodium Topical Solution USP, 2% w/w has an estimated market size of US $512 million for twelve months ending Sep 2022 according to IQVIA
Topiramate Extended-Release capsule had annual sales of US $68.8 mn in the United States according to IQVIA data (IQVIA MAT Sep 2022)
This product is based on Osmotic Controlled Release Oral Delivery System technology
The drug will be manufactured at the group's injectable manufacturing facility at Jarod, near Vadodara, India
The inspection of the facility resulted in issuance of a Form-483 with eight observations each for the Drug Product facility and API facility at the site
The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility
Famotidine Injection is indicated to treat ulcers of the stomach and intestines and to prevent intestinal ulcers from coming back after they have healed
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