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

The recent inspection covered both cGMP and PAI processes

Briefs: Ami Organics and Dr. Reddy’s Laboratories

Ami informs that PMDA Japan has issued Inspection Result Report declaring the Sachin facility as a Good Manufacturing Practices (GMP) compliant.

Sun Pharma and Moebius Medical granted FTD to MM-II for treatment of osteoarthritis knee pain

This Fast Track Designation will enable FDA to review MM-II in an expedited manner, is an important milestone in the development of MM-II

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

NATCO Pharma (Canada) announces US$ 8 million investment in eGenesis

eGenesis is pioneering a genome engineering-based approach in the development of safe and effective transplantable organs to end the global organ shortage

Lupin launches Mirabegron ER tablets in US

Mirabegron Extended-Release Tablets, 50 mg is a generic equivalent of Myrbetriq® Extended-Release Tablets, 50 mg of Astellas Pharma Global Development

Lupin launches Doxorubicin Hydrochloride Liposome Injection in US

ForDoz Pharma Corporation, USA (ForDoz) received an approval for its ANDA from the USFDA

Biocon Pharma receives USFDA approval for daptomycin

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

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