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- Alembic Pharmaceuticals has received final FDA approval for its generic Tretinoin Cream USP (0.025%) to treat acne vulgaris in the US market. - The approved generic is therapeutically equivalent to Bausch Health's reference drug Retin-A Cream, targeting a market estimated at $94 million annually. - This approval brings Alembic's total ANDA portfolio to 224 applications, with 202 final approvals and 22 tentative approvals from the FDA.
- Alembic Pharmaceuticals has secured US FDA approval for Diltiazem Hydrochloride extended-release capsules (120 mg, 180 mg, 240 mg, 300 mg, and 360 mg). - These capsules are indicated for the treatment of hypertension, and may be used alone or in combination with other antihypertensive medications. - The approved ANDA is therapeutically equivalent to Cardizem CD extended-release capsules, offering a generic alternative for patients. - The estimated market size for Diltiazem Hydrochloride extended-release capsules is $105.3 million for the twelve months ending June 2024, according to IQVIA.
- Alembic Pharmaceuticals secured USFDA approval for Diltiazem Hydrochloride Extended-Release Capsules (120-360 mg). - The drug is therapeutically equivalent to Cardizem CD, used for hypertension and chronic stable angina. - The market size for Diltiazem Hydrochloride Extended-Release Capsules is estimated at $105.3 million. - Alembic now has 218 ANDA approvals, including 191 final and 27 tentative approvals.
