Granules India’s Gagillapur facility completes USFDA inspection with six observations

The recent inspection covered both cGMP and PAI processes

Strides receive USFDA approval for Theophylline ER tablets, 300 mg and 450 mg

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug

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

Biocon Pharma receives USFDA approval for daptomycin

The approval further adds to Biocon’s portfolio of complex drug products

Zydus receives warning letter from USFDA for Jarod injectables manufacturing facility

The company will take all necessary steps to work with USFDA towards earliest remediation of the above facility

Zydus receives USFDA final approval for Scopolamine Transdermal System 1 mg/3 days

Natco Pharma announces submission of TABRECTA to USFDA

TABRECTA is the brand of Novartis. Natco believes it is the first company to have filed a substantially-complete ANDA

Suven Life Sciences announces FDA acceptance of investigational new drug

First-in-human Phase-1 study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SUVN-I6107 in healthy subjects

Lupin receives USFDA approval for Brimonidine Tartrate Ophthalmic Solution, 0.1%

Brimonidine Tartrate Ophthalmic Solution, 0.1% is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure

Zydus receives USFDA final approval for Amantadine ER capsules 68.5 mg

Also received tentative approval for 137 mg