India is dependent upon China and other countries for a lot of Key Starting Materials (KSM) for their bulk drug needs.
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:
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
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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