Register entry

Shandong Xinhua Pharmaceutical Company Limited

Data as of · How to read this entry

Registered sites
2
Active NDC listings
62
Labeller names
6
Live patents
0
Countries
1
Base
China
Authorisation

Registered operations

Analytical testing2Active ingredient (API) manufacture2
Sites

Registered establishments

2
EstablishmentAddressRegistered forFEI / DUNS
Shandong Xinhua Pharmaceutical Company Limited Hutian BranchRegistrant: Shandong Xinhua Pharmaceutical Company LimitedHutian Chemical Industrial Zone, Zibo, Shandong 255075, China (CHN)Analytical testing, Active ingredient (API) manufacture3004254526421295757
Shandong Xinhua Pharmaceutical Co Ltd. First PlantRegistrant: Shandong Xinhua Pharmaceutical Company LimitedEAST CHEMICAL ZONE OF ZIBO HIGH & NEW TECHNOLOGY DEVELOPMENT. ZONE, Zibo City, Shandong Province 255075, China (CHN)Analytical testing, Active ingredient (API) manufacture3002808153421252895
Catalogue

Drug listings by form and route

62

62 active NDC listings: 50 bulk ingredient, 10 drug for further processing, 1 human otc drug, 1 human prescription drug. By marketing category: BULK INGREDIENT 50, DRUG FOR FURTHER PROCESSING 10, ANDA 1, OTC MONOGRAPH DRUG 1.

Dosage formNDCs
powder48
tablet, film coated8
tablet, coated4
liquid1
poultice1
RouteNDCs
oral2
Labeller name on the listingNDCs
shandong xinhua pharmaceutical company limited37
shandong xinhua pharmaceutical co., ltd.11
shandong xinhua pharmaceutical co ltd6
shandong xinhua pharmaceutical co ltd.6
shandong xinhua pharmaceutical co. ltd1
shandong xinhua pharmaceutical co., ltd.1
Catalogue

Marketed products

62
BrandGeneric nameForm / routeNDC
-AMINOPHYLLINEpowder58624-0544BULK INGREDIENT
-ASPIRINpowder58624-0612BULK INGREDIENT
-Antipyrinepowder58624-0620BULK INGREDIENT
-Aspirinpowder58624-0452BULK INGREDIENT
-Aspirinpowder58624-0456BULK INGREDIENT
-Aspirinpowder58624-0458BULK INGREDIENT
-Aspirinpowder58624-0466BULK INGREDIENT
-Aspirinpowder58624-0468BULK INGREDIENT
-Aspirinpowder58624-0499BULK INGREDIENT
-Aspirinpowder58624-0622BULK INGREDIENT
-Aspirinpowder58624-0623BULK INGREDIENT
-Aspirinpowder58624-0625BULK INGREDIENT
-Aspirinpowder58624-0626BULK INGREDIENT
-Aspirinpowder58624-0628BULK INGREDIENT
-Bismuth Subsalicylatepowder58624-0711BULK INGREDIENT
-CAFFEINEpowder58624-0306BULK INGREDIENT
-CAFFEINEpowder58624-0308BULK INGREDIENT
-CAFFEINEpowder58624-0312BULK INGREDIENT
-Caffeinepowder58624-0302BULK INGREDIENT
-Caffeinepowder58624-0304BULK INGREDIENT
-Caffeinepowder58624-0310BULK INGREDIENT
-Caffeinepowder58624-0314BULK INGREDIENT
-Caffeinepowder58624-0316BULK INGREDIENT
-Caffeinepowder58624-0534BULK INGREDIENT
-Calcium Polycarbophilpowder58624-0200BULK INGREDIENT
Calcium PolycarbophilCalcium Polycarbophiltablet, film coated, oral58624-5003OTC MONOGRAPH DRUG
-Carbidopapowder58624-0621BULK INGREDIENT
-Glimepiridepowder58624-0708BULK INGREDIENT
-Hydrocortisonepowder58624-0700BULK INGREDIENT
-Hydrocortisonepowder58624-0701BULK INGREDIENT
-Hydrocortisonepoultice58624-0702BULK INGREDIENT
-Hydrocortisonepowder58624-0703BULK INGREDIENT
-Hydrocortisone Acetatepowder58624-0704BULK INGREDIENT
-Hydrocortisone Acetatepowder58624-0705BULK INGREDIENT
-Hydrocortisone Acetatepowder58624-0706BULK INGREDIENT
-Hydrocortisone acetatepowder58624-0710BULK INGREDIENT
-IBUPROFENpowder58624-0050BULK INGREDIENT
-Ibuprofenpowder58624-0051BULK INGREDIENT
-Ibuprofentablet, film coated58624-7001DRUG FOR FURTHER PROCESSING
-Ibuprofentablet, film coated58624-7002DRUG FOR FURTHER PROCESSING
-Ibuprofentablet, film coated58624-7003DRUG FOR FURTHER PROCESSING
-Ibuprofentablet, film coated58624-7004DRUG FOR FURTHER PROCESSING
-Ibuprofentablet, film coated58624-7005DRUG FOR FURTHER PROCESSING
-Ibuprofentablet, film coated58624-7006DRUG FOR FURTHER PROCESSING
-Ibuprofen Sodiumpowder58624-0536BULK INGREDIENT
-LEVODOPApowder58624-0234BULK INGREDIENT
-Levodopapowder58624-0238BULK INGREDIENT
-METAMIZOLE SODIUM MONOHYDRATEpowder58624-0707BULK INGREDIENT
-Meloxicampowder58624-0430BULK INGREDIENT
-Nimodipinepowder58624-0495BULK INGREDIENT
-Omega-3-Acid Ethyl Estersliquid58624-0712BULK INGREDIENT
-Phenobarbitalpowder58624-0520BULK INGREDIENT
-SALICYLIC ACIDpowder58624-0610BULK INGREDIENT
SEVELAMER CARBONATESEVELAMER CARBONATEtablet, film coated, oral58624-5001ANDA
-Sevelamer Carbonatepowder58624-0709BULK INGREDIENT
-TRAMADOL HYDROCHLORIDEpowder58624-0201BULK INGREDIENT
-Theophyllinepowder58624-0401BULK INGREDIENT
-Theophylline Anhydrouspowder58624-0713BULK INGREDIENT
-ibuprofentablet, coated58624-6001DRUG FOR FURTHER PROCESSING
-ibuprofentablet, coated58624-6002DRUG FOR FURTHER PROCESSING
-ibuprofentablet, coated58624-6003DRUG FOR FURTHER PROCESSING
-ibuprofentablet, coated58624-6004DRUG FOR FURTHER PROCESSING
Neighbours

Registered in the same town

4
Compare

Comparable companies in China

Enquiry

Common questions

Is Shandong Xinhua Pharmaceutical Company Limited FDA approved?
Shandong Xinhua Pharmaceutical Company Limited holds 2 FDA-registered establishments in China. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Shandong Xinhua Pharmaceutical Company Limited's drugs manufactured?
The FDA register lists Zibo; Zibo City. Registered operations: analytical testing, active ingredient (API) manufacture.
What drugs does Shandong Xinhua Pharmaceutical Company Limited make?
62 products are listed under Shandong Xinhua Pharmaceutical Company Limited in the openFDA NDC Directory, most often as powder; tablet, film coated; tablet, coated. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.