Tag: ANDA
GENERAL Morepen Labs Files First ANDA, Eyes US Market With Sitagliptin Tablets

Morepen Laboratories Ltd has submitted its first Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA) for Sitagliptin tablets USP in 25 mg, 50 mg and 100 mg strengths, marking the company’s entry into integrated finished dosage development and US regulatory filings. The submission expands Morepen’s established active pharmaceutical ingredient (API) […]

CW Bureau · Sep 28, 2026
GENERAL Aurobindo Pharma Gets USFDA Nod For Dapagliflozin-Metformin Combo

Aurobindo Pharma Ltd has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Dapagliflozin and Metformin Hydrochloride extended-release tablets in multiple strengths such as 5 mg/500 mg, 5 mg/1000 mg, 10 mg/500 mg, and 10 mg/1000 mg. The approved formulation is bioequivalent and therapeutically equivalent to the reference listed […]

CW Bureau · Apr 7, 2026