Zydus receives final approval from USFDA for Topiramate Extended-Release capsules
Topiramate Extended-Release capsule had annual sales of US $68.8 mn in the United States according to IQVIA data (IQVIA MAT Sep 2022)
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 $56 million for twelve months ending September 2022
The pre-approval inspection of USFDA was completed successfully with ZERO 483 observation of the manufacturing facilities of Bajaj Healthcare Limited
The approval further strengthens the Potassium Chloride franchise for the company.
The product is expected to be launched by Q4 FY23.
Cyclophosphamide Capsules, 25 mg and 50 mg, have an estimated market size of US$ 8 million for twelve months ending Sep 2022 according to IQVIA.
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