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

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

Medix Biochemica appoints former Roche executive to its Board of Directors

Dr. Pedrocchi is currently an Independent Strategic Advisor and Non-Executive Director to private and public healthcare companies.

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

Granules India receives ANDA approval for Loperamide Hydrochloride and Simethicone Tablets

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).

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).

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

Granules India received ANDA approval for Guaifenesin and Pseudoephedrine Hydrochloride ER

Granules now have a total of 51 ANDA approvals from US FDA (49 Final approvals and 2 tentative approvals).

Lupin receives UK MHRA Approval of Lutio for treatment of COPD

Lutio has the potential to offer significant cost savings when available to UK patients.