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
NATCO to sell 15% of shareholding in Nativita for euro 3,45,000 to Pharmasyntez-Nord
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
Subject Expert Committee(SEC) of Central Drugs Standard Control Organization (CDSCO)
The observations primarily relate to the need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications & computerized tools
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
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).
Dasatinib Tablets (RLD Sprycel) had estimated annual sales of USD 1569 million in the U.S. (IQVIA MAT June 2022).
Glenmark continues to cooperate with the US FDA and is committed to undertake all necessary steps required to address their observations at the earliest.
Subscribe To Our Newsletter & Stay Updated
