Drug Approval | December 20, 2022
USFDA inspection at Alembic Pharmaceuticals’ facility at Jarod
None of the observations are related to data integrity and management believes that they are addressable
None of the observations are related to data integrity and management believes that they are addressable
The company will submit an action plan on the observations and will engage with US FDA for next steps.
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
Topiramate Extended-Release capsule had annual sales of US $68.8 mn in the United States according to IQVIA data (IQVIA MAT Sep 2022)
_256_384.png)
Leuprolide Acetate Injection Depot contains 22.5 mg of leuprolide acetate for 3- month administration given as a single dose injection.
The drug will be manufactured at the group's injectable manufacturing facility at Jarod, near Vadodara, India
Government of India has granted a patent for invention entitled "An improved safe process for the preparation of Sartan drugs of Formula I".
Famotidine Injection is indicated to treat ulcers of the stomach and intestines and to prevent intestinal ulcers from coming back after they have healed
The company had responded to the agency and carried out the required corrective actions.
Subscribe To Our Newsletter & Stay Updated
