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
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.
The drive also conducted a mega health camp, cancer screening for women and men, ENT screening for children, and blood donation drive
The company has received 1 (ONE) observation on Form 483 with respect to ANDA filed for the product to be manufactured at the said Facility.
First and only PARP inhibitor to improve invasive disease-free survival, the primary endpoint, and overall survival, a key secondary endpoint of the OlympiA trial, in these patients
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