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
Phase-III trials were conducted for safety, and immunogenicity in around 3,100 subjects, in 14 trial sites across India (supported by BIRAC)
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 product is based on Osmotic Controlled Release Oral Delivery System technology
Dapagliflozin reduces the risk of sustained eGFR, cardiovascular deaths and hospitalization for heart failure in adults with CKD
The drug will be manufactured at the group's injectable manufacturing facility at Jarod, near Vadodara, India
Famotidine Injection is indicated to treat ulcers of the stomach and intestines and to prevent intestinal ulcers from coming back after they have healed
Nifedipine Extended-Release Tablets have an estimated market size of US $56 million for twelve months ending September 2022
The pre-approval inspection of USFDA was completed successfully with ZERO 483 observation of the manufacturing facilities of Bajaj Healthcare Limited
Subscribe To Our Newsletter & Stay Updated
