Briefs: Lupin, Alembic Pharmaceuticals and Piramal Pharma

Lupin's Pithampur Unit-1 gets Form 483 from USFDA with 3 observations

Alembic receives USFDA final approval for Paliperidone ER tablets

Paliperidone extended-release tablets are an atypical antipsychotic agent indicated for treatment of schizophrenia

Alembic appoints Sudhakar Pandiyan as Head - Technical Operations

He has been associated with Caplin Steriles Ltd., Mylan Laboratories Ltd., Caplin Point Laboratories Ltd., Strides Arcolab Ltd. and Novartis Vaccines and Diagnostics

Alembic Pharmaceuticals receives USFDA final approval for Albendazole Tablets USP, 200 mg

Alembic receives FDA final approval for Betamethasone Valerate Foam, 0.12%

Alembic receives USFDA final approval for Dabigatran Etexilate Capsules, 110 mg

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pradaxa Capsules, 110 mg of Boehringer Ingelheim Pharmaceuticals

Alembic receives USFDA final approval for Nelarabine Injection, 250 mg/50 mL

Nelarabine is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukemia

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