Drug factory · FDA FEI 3008865184

Kindos Pharmaceuticals Co., Ltd.

No.8-9 Kexin Road, Chengdu Hi-Tech Comprehensive Bonded Zone, Chengdu, China

China: 1

Problems found, fixed voluntarily at FDA's last inspection, Jul 19, 2024.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

6 drug inspections on record since 2012: 2 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
Albumin Human and DocetaxelMakes it and tests it Zydus Pharmaceuticals (USA) Inc. 70710-2091, 70710-2093
AzacitidineMakes it Meitheal Pharmaceuticals Inc. 71288-115, 71288-153
BortezomibMakes it and tests it BluePoint Laboratories., Meitheal Pharmaceuticals Inc. 68001-534, 71288-118
BusulfanMakes it Meitheal Pharmaceuticals Inc. 71288-116, 71288-158
ClofarabineMakes it Meitheal Pharmaceuticals Inc. 71288-128
CytarabineMakes it Meitheal Pharmaceuticals Inc. 71288-108, 71288-109, 71288-168 +1
DactinomycinMakes it Meitheal Pharmaceuticals Inc. 71288-129
DalbavancinMakes it Meitheal Pharmaceuticals Inc. 71288-034
DesmopressinMakes it Meitheal Pharmaceuticals Inc. 71288-440, 71288-441
DocetaxelMakes it and tests it Zhuhai Beihai Biotech Co., Ltd., Zydus Pharmaceuticals (USA) Inc. 83513-008, 83513-009, 70710-2092 +1
DoxycyclineMakes it Meitheal Pharmaceuticals Inc. 71288-030
EribulinMakes it Glenmark Pharmaceuticals Inc., USA, Hikma Pharmaceuticals USA Inc., Kindos Pharmaceuticals Co., Ltd., Meitheal Pharmaceuticals Inc. 68462-770, 0143-9167, 40033-364 +1
EtoposideMakes it BluePoint Laboratories. 68001-681, 68001-682, 68001-683
FluorouracilMakes it Meitheal Pharmaceuticals Inc. 71288-154, 71288-170
GemcitabineMakes it, tests it and packages it Dr.Reddy's Laboratories Ltd. 55111-686, 55111-687
HydralazineMakes it Meitheal Pharmaceuticals Inc. 71288-205
LefamulinMakes it Meitheal Pharmaceuticals Inc. 71288-039
LeucovorinMakes it BluePoint Laboratories., Meitheal Pharmaceuticals Inc. 68001-648, 68001-649, 68001-650 +5
LevoleucovorinMakes it Meitheal Pharmaceuticals Inc. 71288-104, 71288-105
MitomycinMakes it Meitheal Pharmaceuticals Inc. 71288-137, 71288-138, 71288-139
MitoxantroneMakes it Meitheal Pharmaceuticals Inc. 71288-178, 71288-179
Mycophenolic AcidMakes it Meitheal Pharmaceuticals Inc. 71288-803
NelarabineMakes it Meitheal Pharmaceuticals Inc. 71288-165
OxaliplatinMakes it Meitheal Pharmaceuticals Inc., Northstar Rx LLC. 71288-171, 71288-172, 72603-320 +1
RopivacaineMakes it Meitheal Pharmaceuticals Inc. 71288-732, 71288-733, 71288-734 +4
TelavancinMakes it Cumberland Pharmaceuticals Inc. 66220-315
ThiotepaMakes it Meitheal Pharmaceuticals Inc. 71288-156, 71288-157
VancomycinMakes it Meitheal Pharmaceuticals Inc. 71288-022, 71288-023, 71288-024 +2

FDA inspection history

EndedResultProgramProblems noted
Jul 19, 2024Problems found, fixed voluntarilyDrug Quality Assurance—
Jul 30, 2019No problems foundDrug Quality Assurance—
Apr 1, 2017Problems found, fixed voluntarilyDrug Quality Assurance—
Jun 2, 2016No problems foundDrug Quality Assurance—
Apr 10, 2015Problems found, fixed voluntarilyDrug Quality Assurance—
Jul 24, 2012Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture; label; manufacture; pack; repack; sterilize.