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Granules receives ANDA approval for amphetamine mixed salts
Drug Approval | December 30, 2021

Granules receives ANDA approval for amphetamine mixed salts

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


Sanofi loses appeal in the US over Lantus device patents
News | December 30, 2021

Sanofi loses appeal in the US over Lantus device patents

Decisions reaffirm the ability of Biocon Biologics and Viatris to provide patient access to interchangeable Semglee


U.S. FDA approves Leo Pharma’s Adbry
Drug Approval | December 29, 2021

U.S. FDA approves Leo Pharma’s Adbry

Adbry is the first biologic launched by LEO Pharma in the United States and is expected to be available in pharmacies by February 2022


Granules Inc., receives ANDA approval for prazosin hydrochloride
Drug Approval | December 28, 2021

Granules Inc., receives ANDA approval for prazosin hydrochloride

The current annual U.S. market for prazosin hydrochloride 1mg, 2mg, 5mg strengths is approximately US $ 54 million, according to IQVIA/IMS Health


Trastuzumab deruxtecan type II variation application validated by EMA
Biotech | December 28, 2021

Trastuzumab deruxtecan type II variation application validated by EMA

Application based on DESTINY-Breast03 results showing Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan reduced risk of disease progression or death by 72% versus trastuzumab emtansine (T-DM1)


NATCO receives approval for the drug for the treatment of Covid-19
Drug Approval | December 28, 2021

NATCO receives approval for the drug for the treatment of Covid-19

Natco Pharma has received approval for Covid 19 drug molnupiravir capsules 200 mg. for Indian market, which will be sold under brand name Molnunat


RaphaCure partners with Zeebon for foraying into North East market
Clinical Trials | December 28, 2021

RaphaCure partners with Zeebon for foraying into North East market

Zeebon is the largest diagnostics services provider in North-Eastern states


Sun Pharma receives DCGI approval for Molxvir in India
Drug Approval | December 28, 2021

Sun Pharma receives DCGI approval for Molxvir in India

The product is expected to be available in a week’s time


Covaxin receives approval for Emergency Use in Children 12-18 years
Drug Approval | December 27, 2021

Covaxin receives approval for Emergency Use in Children 12-18 years

Covaxin is formulated uniquely such that the same dosage can be administered to adults and children


Lupin receives U.S. FDA approval for Sevelamer Carbonate
Drug Approval | December 27, 2021

Lupin receives U.S. FDA approval for Sevelamer Carbonate

This product will be manufactured at Lupin's Goa facility in India