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5610 News Found

Centre grants approval of three Bulk Drug Parks
Policy | September 02, 2022

Centre grants approval of three Bulk Drug Parks

The Bulk Drug Parks to be developed under the scheme will provide common infrastructure facilities at one place thereby creating a robust ecosystem for the bulk drug manufacturing in the country and also reducing manufacturing cost significantly


Daiichi Sankyo announces initiation of Phase 3 Trial of mRNA
Clinical Trials | September 01, 2022

Daiichi Sankyo announces initiation of Phase 3 Trial of mRNA

COVID-19 Vaccine (DS-5670) in Unvaccinated Individuals in Japan


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


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


Ayush Minister unveils “Science Behind Suryanamaskar” book
News | August 29, 2022

Ayush Minister unveils “Science Behind Suryanamaskar” book

The book “Science behind Suryanamaskar” has been compiled by the AIIA’s Department of Swasthavritta and Yoga.


Alembic Pharmaceuticals receives USFDA final approval for Chlorthalidone Tablets USP
Drug Approval | August 29, 2022

Alembic Pharmaceuticals receives USFDA final approval for Chlorthalidone Tablets USP

he approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Hygroton Tablets, 25 mg and 50 mg, of Sanofi Aventis US. LLC (Sanofi).


Moderna sues Pfizer, BioNTech for mRNA patent infringement
News | August 28, 2022

Moderna sues Pfizer, BioNTech for mRNA patent infringement

Complaints to be filed in both United States and Germany alleging that Pfizer and BioNTech's COVID-19 vaccine Comirnaty unlawfully infringes patents Moderna filed between 2010 and 2016


Qdenga approved in Indonesia for use regardless of prior dengue exposure
Drug Approval | August 28, 2022

Qdenga approved in Indonesia for use regardless of prior dengue exposure

Indonesia national agency for drug and food control, BPOM, approved QDENGA for use in individuals 6 to 45 years of age