Drug Approval | April 10, 2024
Shivalik Rasayan’s API facility gets 7 observations from USFDA
These observations are procedural in nature and will be responded within the stipulated time
These observations are procedural in nature and will be responded within the stipulated time
The observations are procedural in nature and will be responded to within the stipulated time
The Product is expected to be the first generic approval on the market
The inspection at Unit 1 by the USFDA has been successfully completed, with no observations under Form 483
Letermovir tablets, 240 mg and 480 mg had annual sales of USD 289.5 mn in the United States (IQVIA MAT Jan-24)
The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ II, India
Chlorpromazine Hydrochloride Injection is used to treat certain mental/mood disorders
The company will provide comprehensive response to USFDA for the observations
Cipla completes transfer of Generics Business Undertaking
Eugia Pharma Specialities restarts production at terminally sterilized product lines
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