Briefs: Indoco Remedies and Alembic Pharmaceuticals

Indoco Remedies is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe

Alembic receives USFDA’s final approval for Fluphenazine Hydrochloride Tablets

Alembic announces USFDA tentative approval for Selexipag for Injection, 1,800 mcg/vial

Selexipag is a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension

Alembic Pharmaceuticals announces USFDA Final Approval for Bromfenac Ophthalmic Solution, 0.07%

The approved ANDA is therapeutically equivalent to the reference listed drug product

Briefs: Alembic Pharmaceuticals and Relonchem

Alembic Pharmaceuticals receives 11 USFDA product approval during Q1 FY2025

Alembic announces USFDA tentative approval for Bosutinib Tablets, 100 mg and 500 mg

Alembic Pharmaceuticals announces USFDA final approval for Doxycycline Capsules, 40 mg

Doxycycline capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients

Alembic Pharmaceuticals gets USFDA final approval for Dabigatran Etexilate capsules

Dabigatran Etexilate Capsules are indicated for reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation in adult patients

Alembic announces USFDA final approval for Icatibant injection

This is the first peptide product approval from the USFDA received by Alembic Pharmaceuticals

Alembic Pharmaceuticals receives USFDA final approval for Sacubitril and Valsartan Tablets

Sacubitril and Valsartan Tablets are indicated to reduce the risk of cardiovascular death