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1676 News Found

Zydus receives final approval from USFDA for two tablets
Drug Approval | September 01, 2022

Zydus receives final approval from USFDA for two tablets

The group now has 322 approvals and has so far filed over 428 ANDAs since the commencement of the filing process in FY 2003-04


US FDA issues 17 observations for Biocon Biologics sites
News | September 01, 2022

US FDA issues 17 observations for Biocon Biologics sites

The observations primarily relate to the need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications & computerized tools


Stelis Biopharma’s flagship facility receives EIR from USFDA
Drug Approval | September 01, 2022

Stelis Biopharma’s flagship facility receives EIR from USFDA

The integrated capabilities at Unit 2 offer significant operational flexibility, greater efficiency, and varied scope within the same premise


Bayer showcases cancer study data at ESMO Congress 2022
News | September 01, 2022

Bayer showcases cancer study data at ESMO Congress 2022

On the precision oncology front, expanded larotrectinib data will focus on efficacy and safety findings for pediatric and adult patients with NTRK gene fusion-positive solid tumors


A 10-year commission with dedicated mission is required to tackle the upsurge of diabetes in India: says Expert
Healthcare | September 01, 2022

A 10-year commission with dedicated mission is required to tackle the upsurge of diabetes in India: says Expert

India is at the forefront of research in cardiology worldwide but making indigenous products is what we are lacking & it needs to be improved


Alembic Pharmaceuticals receives USFDA Final Approval for Chlorthalidone Tablets
News | August 31, 2022

Alembic Pharmaceuticals receives USFDA Final Approval for Chlorthalidone Tablets

Chlorthalidone Tablets USP, 25 mg and 50 mg, have an estimated market size of US $37 million for twelve months ending June, 2022 according to IQVIA


Hikma launches seasonal allergic rhinitis nasal spray RYALTRIS in the US
News | August 31, 2022

Hikma launches seasonal allergic rhinitis nasal spray RYALTRIS in the US

This launch builds upon Hikma’s leading position as one of the largest US providers of nasally administered medicines used for treating seasonal allergies and advances its objective of growing its specialty business in the US


Lupin receives tentative approval from USFDA for Dasatinib Tablets
Drug Approval | August 29, 2022

Lupin receives tentative approval from USFDA for Dasatinib Tablets

Dasatinib Tablets (RLD Sprycel) had estimated annual sales of USD 1569 million in the U.S. (IQVIA MAT June 2022).