News | March 15, 2022
Granules Pharmaceuticals clears USFDA audit
This is the sixth successful USFDA audit for this facility
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
The capsules are indicated for the maintenance of normal sinus rhythm in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm
The issue will consist of the issuance of fresh equity shares worth up to Rs 331.60 crore and an offer for sale (OFS) of Rs 500 crore by promoters and existing shareholders
India is dependent upon China and other countries for a lot of Key Starting Materials (KSM) for their bulk drug needs.
The US FDA has closed the observations pertaining to this audit with an Establishment Inspection Report on the 20th of July 2021
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