Drug Approval | September 06, 2021
Alembic JV Aleor receives US FDA final approval for skin disorder gel
Metronidazole Gel USP, 1% is indicated for the topical treatment of inflammatory lesions of rosacea
Metronidazole Gel USP, 1% is indicated for the topical treatment of inflammatory lesions of rosacea
The product will be available in 500 mg/2.5 mL and 1 g/5 mL vials
Price erosion, weak demand for acute portfolio and low ANDA approvals in the US weighed on the performance of Indian pharma in Q1FY22. However, the scenario is expected to change in H2FY22 when new approvals and inspections resume
The group has a total of 320 ANDA approvals
It had an estimated market size of US $ 32 million as of June 2021
The company has a cumulative total of 147 ANDA approvals (129 final approvals and 18 tentative approvals) from USFDA
Lurasidone Hydrochloride tablets are also indicated for adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder
Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution USP, 2% and 0.5% has an estimated market size of US $80 million for twelve months ending December 2020 according to IQVIA
ranules now has a total of 38 ANDA approvals from US FDA.
Granules now has a total of 37 ANDA approvals from US FDA (36 Final approvals and 1 tentative approvals).
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