Drug factory · FDA FEI 3007721552

Sunshine Lake Pharma Co., Ltd.

No. 1, Northern Industry Road, Northern Industry Park of Song Shan Lake, Dongguan, China

China: 1

Problems found, fixed voluntarily at FDA's last inspection, Mar 22, 2024.

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

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

What it does, for whom

DrugRoleForNDC
AzithromycinMakes it Lannett Company, Inc., Rising Pharma Holdings, Inc. 0527-2370, 0527-2395, 64980-726 +1
BrivaracetamMakes it Solaris Pharma Corporation 73473-904, 73473-905, 73473-906 +2
ClarithromycinMakes it Lannett Company, Inc., Solaris Pharma Corporation 0527-1930, 0527-1931, 0527-1932 +3
EntacaponeMakes it Lannett Company, Inc., Rising Pharma Holdings, Inc. 0527-1830, 64980-722
FebuxostatMakes it HEC Pharm USA Inc., Lannett Company, Inc. 72303-0855, 72303-0856, 0527-2244 +1
FingolimodMakes it Rising Pharma Holdings, Inc. 64980-449
IbuprofenMakes it Sunshine Lake Pharma Co., Ltd. 48792-7811, 48792-7812, 48792-7813
LinagliptinMakes it Sunshine Lake Pharma Co., Ltd. 48792-7865
MoxifloxacinMakes it Solaris Pharma Corporation 73473-903
OlanzapineMakes it HEC Pharm USA Inc., Lannett Company, Inc. 72303-0835, 72303-0836, 72303-0837 +11
OlmesartanMakes it HEC Pharm USA Inc., Lannett Company, Inc. 72303-0848, 72303-0849, 72303-0850 +3
Oseltamivir AcidMakes it HEC Pharm USA Inc., Lannett Company, Inc. 72303-0851, 0527-4591, 0527-4592 +2
RosuvastatinMakes it HEC Pharm USA Inc. 72303-0827, 72303-0828, 72303-0829 +1
SildenafilMakes it HEC Pharm USA Inc. 72303-0845, 72303-0846, 72303-0847
SolifenacinMakes it HEC Pharm USA Inc. 72303-0831, 72303-0832
TadalafilMakes it HEC Pharm USA Inc. 72303-0822, 72303-0823, 72303-0824 +1
TicagrelorMakes it Oryza Pharmaceuticals Inc. 72516-017, 72516-018

FDA inspection history

EndedResultProgramProblems noted
Mar 22, 2024Problems found, fixed voluntarilyDrug Quality Assurance—
Oct 19, 2017Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 25, 2015Serious problems, FDA actionDrug Quality Assurance—
Mar 14, 2014No problems foundDrug Quality Assurance—
Apr 21, 2011Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: manufacture.