Drug Approval | January 28, 2022
Granules receives ANDA approval for potassium chloride for oral solution USP, 20 mEq
Potassium chloride is used to prevent or to treat low blood levels of potassium
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
Acetaminophen extended-release tablets 650 mg is bioequivalent of the reference listed drug Tylenol
The US FDA has closed the observations pertaining to this audit with an Establishment Inspection Report on the 20th of July 2021
In an exclusive interview with Rahul Koul of Indian Chemical News, Priyanka Chigurupati, Executive Director, Granules Pharmaceuticals Inc. USA shared details about the company's performance, R&D initiatives, Capex plan, CSR, and future outlook. Excerpts of the interview:
ranules now has a total of 38 ANDA approvals from US FDA.
Granules now has a total of 37 ANDA approvals from US FDA (36 Final approvals and 1 tentative approvals).
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