This was a pre-approval inspection to cover our Oncology Injectable drug products for which ANDAs were filed with USFDA
Silodosin capsules treat signs and symptoms of an enlarged prostate gland
Patients receiving Polivy plus R-CHP for DLBCL reported similar health-related quality of life outcomes
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
Antibody levels remained above baseline six months after completion of a three-dose (Month 0-2-6) or a two-dose (Month 0-6) vaccination schedule
Application includes data from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary efficacy endpoints
Topiramate Extended-Release capsule had annual sales of US $68.8 mn in the United States according to IQVIA data (IQVIA MAT Sep 2022)
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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
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