Drug Approval | October 19, 2022
USFDA visit to Alembic Pharmaceuticals Panelav facility
None of the observations are related to data integrity and Alembic Pharmaceuticals management believes that they are addressable
None of the observations are related to data integrity and Alembic Pharmaceuticals management believes that they are addressable
Chlorthalidone Tablets USP, 25 mg and 50 mg, have an estimated market size of US $37 million for twelve months ending June, 2022 according to IQVIA
The RRA was conducted from 22nd August, 2022 to 26th August, 2022.
he approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Hygroton Tablets, 25 mg and 50 mg, of Sanofi Aventis US. LLC (Sanofi).
Dasatinib Tablet is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive
The appraisal of the applications has been carried out based on the ranking methodology laid down in the operational guidelines of the Scheme
Metronidazole Gel USP, 1% is indicated for the topical treatment of inflammatory lesions of rosacea
The US business faced price erosion due to increased competition.
The company has a cumulative total of 147 ANDA approvals (129 final approvals and 18 tentative approvals) from USFDA
Glenmark has been granted a competitive generic therapy (CGT) designation for theophylline extended-release tablets
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