Drug Approval | 12 December 2022
Alembic receives USFDA final Approval for Desonide Cream
Desonide Cream, 0.05%, has an estimated market size of US $12 million for twelve months ending Sep 2022 according to IQVIA
Desonide Cream, 0.05%, has an estimated market size of US $12 million for twelve months ending Sep 2022 according to IQVIA
This was a pre-approval inspection to cover our Oncology Injectable drug products for which ANDAs were filed with USFDA
Silodosin capsules treat signs and symptoms of an enlarged prostate gland
The approval follows the positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in October 2022
Soluplus branded excipient play a critical role in enabling the drug development process for poorly soluble active pharmaceutical ingredients
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad
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
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Leuprolide Acetate Injection Depot contains 22.5 mg of leuprolide acetate for 3- month administration given as a single dose injection.
South Asia’s largest exhibition for pharma brought together over 50,000 visitors from across the globe
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
Approval broadens indication for ENHERTU to earlier use in metastatic breast cancer and requirement for confirmatory phase 3 trial
The receipt of this permission paves way for the launch of Dapagliflozin (Forxiga) tablets of 10 mg in India for the specified additional/expanded indication, subject to the receipt of related statutory approvals
If approved, TAK-003 has the potential to become an important dengue prevention option for healthcare providers
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 company had responded to the agency and carried out the required corrective actions.
The product is expected to be launched by Q4 FY23.
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