Drug Approval | January 17, 2022
Glenmark Pharmaceuticals receives ANDA tentative approval for Regadenoson injection
The company has 47 ANDA's pending approval with the U.S.FDA
The company has 47 ANDA's pending approval with the U.S.FDA
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 proposed scheme to include low-income NRIs under Ayushman Bharat (PM-JAY) would ensure life-long coverage for each individual along with their spouses
The product will be commercialized from Unichem's Ghaziabad plant
This further adds to Biocon’s portfolio of vertically integrated complex drug products
The Indian Pharmacopoeia Commission (IPC) has added 23 new impurities standards and 7 new Indian Pharmacopoeial Reference standards
The NFI is published to promote the rational use of medicines in the country.
FDI increased 98% year on year in 2020 and pharma exports grew by 18% in the last financial year
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
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