Lupin gets tentative FDA nod for Revefenacin inhalation solution

The drug is indicated for the maintenance treatment of patients with Chronic Obstructive Pulmonary Disease (COPD)

Glenmark Pharma introduces Vancomycin Injection in U.S. market

The product is bioequivalent and therapeutically equivalent to the reference listed drug by Fresenius Kabi USA, LLC.

Lupin receives USFDA nod for Famotidine injection

Famotidine Injection USP is a generic version of Pepcid injection to be manufactured at its Nagpur facility for the U.S. market

Lupin receives USFDA approval for generic Ravicti oral liquid

Approval expands Lupin’s specialty portfolio in the US market for treatment of urea cycle disorders

Lupin launches Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets in USA

The product is approved as bioequivalent to Xigduo XR for the indications outlined in the reference drug’s labelling

Aurobindo Pharma wins key FDA nod for $138M US cough drug market entry

The drug is designed to provide temporary relief from cough caused by throat and bronchial irritation

Aurobindo Pharma wins USFDA nod for rare disease drug set for immediate launch

MSN Laboratories launches SEMABEST, India-made semaglutide pen at nearly 50% lower price

CDSCO-approved therapy enters India’s fast-growing post-patent GLP-1 market with fully integrated API, formulation and pen manufacturing

Lupin scores major US breakthrough with FDA nod for key diabetes drug

The Abbreviated New Drug Application with FDA covers multiple strengths of Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets

India’s Dapagliflozin Moment: Why USFDA’s generic greenlight wave matters

In just the last few days, companies including Lupin, Biocon, Alembic Pharmaceuticals and Aurobindo Pharma have announced approvals for 5 mg and 10 mg tablets, all bioequivalent to Farxiga