Drug Approval | December 19, 2022
Sun Pharmaceutical receives warning letter from USFDA for Halol facility
The Halol facility was placed under Import Alert by USFDA.
The Halol facility was placed under Import Alert by USFDA.
Desonide Cream, 0.05%, has an estimated market size of US $12 million for twelve months ending Sep 2022 according to IQVIA
Silodosin capsules treat signs and symptoms of an enlarged prostate gland
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
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