Drug factory · FDA FEI 3007498452

Hangzhou Minsheng Binjiang Pharmaceutical Co.,Ltd

658 Bin'an Road Binjiang District, Hangzhou, China

China: 1

Serious problems, FDA action at FDA's last inspection, Mar 7, 2025.

Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.

6 drug inspections on record since 2011: 2 with no problems, 3 with problems fixed voluntarily, 1 with FDA action.

What it does, for whom

DrugRoleForNDC
Alendronic AcidMakes it Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd. 60723-205, 60723-207
BupropionMakes it Chartwell RX, LLC., Lannett Company, Inc., Mullan Pharmaceutical Inc., Vitruvias Therapeutics, Inc. 62135-875, 62135-876, 0527-2415 +5
MontelukastMakes it Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd., Westminster Pharmaceuticals, LLC 60723-004, 60723-005, 60723-010 +1
Risedronic AcidMakes it Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd. 60723-041

FDA inspection history

EndedResultProgramProblems noted
Mar 7, 2025Serious problems, FDA actionDrug Quality Assurance—
Sep 13, 2019No problems foundDrug Quality Assurance—
May 11, 2018No problems foundDrug Quality Assurance—
Jul 29, 2016Problems found, fixed voluntarilyDrug Quality Assurance—
Apr 25, 2014Problems found, fixed voluntarilyDrug Quality Assurance—
Jun 10, 2011Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis; label; manufacture; pack.