Drug Approval | December 05, 2022
Zydus receives final approval from USFDA for Estradiol Transdermal System
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad
Antibody levels remained above baseline six months after completion of a three-dose (Month 0-2-6) or a two-dose (Month 0-6) vaccination schedule
Presentations include new data on investigational medicines – favezelimab (MK-4280), zilovertamab vedotin (MK-2140) and nemtabrutinib – as well as KEYTRUDA (pembrolizumab) in multiple blood cancers
Application includes data from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary efficacy endpoints
Phase-III trials were conducted for safety, and immunogenicity in around 3,100 subjects, in 14 trial sites across India (supported by BIRAC)
With this QIP placement, the Dhanuka group, which took over the company in 2018, is also meeting its mandatory obligation to dilute 15 percent stake in the company by March 2023
Diclofenac Sodium Topical Solution USP, 2% w/w has an estimated market size of US $512 million for twelve months ending Sep 2022 according to IQVIA
Topiramate Extended-Release capsule had annual sales of US $68.8 mn in the United States according to IQVIA data (IQVIA MAT Sep 2022)
This is the second line opened this year for parenteral drug product clinical and commercial manufacturing, with an annual capacity of 10 million units
TPE tubing is ideal for pharmaceutical bioprocessing applications because it can be welded to existing tubing lines, and heat-sealed to allow for easy, fast, and safe fluid transport in biopharma processes
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