Drug Approval | March 22, 2023
Granules Consumer Health concludes FDA audit with zero observations
The audit is a pre-approval inspection for three products filed from the facility
The audit is a pre-approval inspection for three products filed from the facility
Granules now have a total of 53 ANDA approvals from USFDA
He was previously associated with renowned companies such as Granules India Ltd, Dr. Reddy’s Laboratories ltd & Aptar Group
Greenko ZeroC will supply Carbon Free Energy and enable Green Hydrogen along with its various chemical derivatives.
This is the sixth successful USFDA audit for this facility
It has a total of 50 ANDA approvals from USFDA
The audit is a PAI for two of its product applications filed from this facility
Potassium chloride is used to prevent or to treat low blood levels of potassium
The current annual U.S. market for amphetamine mixed salts, USP 1.25mg, 1.875mg, 2.5mg, 3.125mg, 3.75mg, 5mg, 7.5mg immediate release tablets strengths is approximately US $ 335 million, according to MAT, Oct 2021 IQVIA/IMS Health
The current annual U.S. market for prazosin hydrochloride 1mg, 2mg, 5mg strengths is approximately US $ 54 million, according to IQVIA/IMS Health
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