Register entry

Shandong Anxin Pharmaceutical Co., Ltd.

Data as of · How to read this entry

Registered sites
2
Active NDC listings
11
Live patents
0
Countries
1
Base
China
Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture2Labelling1Finished drug manufacture1Packaging1
Sites

Registered establishments

2
EstablishmentAddressRegistered forFEI / DUNS
Shandong Anxin Pharmaceutical Co., Ltd. (Laoling site)Registrant: Shandong Anxin Pharmaceutical Co., Ltd.Circular Economy Demonstration Park, Laoling County, Dezhou, 253600, China (CHN)Active ingredient (API) manufacture3023338181699487072
Shandong Anxin Pharmaceutical Co., Ltd.No. 849, Dongjia Town, Licheng Dist., Jinan, 250105, China (CHN)Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging3004229375554518058
Catalogue

Drug listings by form and route

11

11 active NDC listings: 7 bulk ingredient, 4 human prescription drug. By marketing category: BULK INGREDIENT 5, ANDA 4, BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING 2.

Dosage formNDCs
powder7
injection, powder, for solution3
injection, powder, lyophilized, for solution1
RouteNDCs
intravenous4
Labeller name on the listingNDCs
shandong anxin pharmaceutical co., ltd.11
Catalogue

Marketed products

11
BrandGeneric nameForm / routeNDC
-Amikacin Sulfatepowder35369-0005BULK INGREDIENT
-Capecitabinepowder35369-0010BULK INGREDIENT
-Docetaxelpowder35369-0022BULK INGREDIENT
-Hydroxyureapowder35369-0006BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-Irinotecan Hydrochloridepowder35369-0020BULK INGREDIENT
-Piperacillin Sodium and Tazobactam Sodiumpowder35369-0007BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Piperacillin and TazobactamPIPERACILLIN and TAZOBACTAMinjection, powder, for solution, intravenous35369-0501ANDA
Piperacillin and TazobactamPIPERACILLIN and TAZOBACTAMinjection, powder, for solution, intravenous35369-0502ANDA
Piperacillin and TazobactamPIPERACILLIN and TAZOBACTAMinjection, powder, for solution, intravenous35369-0503ANDA
Piperacillin and TazobactamPiperacillin and Tazobactaminjection, powder, lyophilized, for solution, intravenous35369-0504ANDA
-Tazobactam Sodiumpowder35369-0009BULK INGREDIENT
Neighbours

Registered in the same town

7
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Comparable companies in China

Enquiry

Common questions

Is Shandong Anxin Pharmaceutical Co., Ltd. FDA approved?
Shandong Anxin Pharmaceutical Co., Ltd. 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 Anxin Pharmaceutical Co., Ltd.'s drugs manufactured?
The FDA register lists Dezhou; Jinan. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
What drugs does Shandong Anxin Pharmaceutical Co., Ltd. make?
11 products are listed under Shandong Anxin Pharmaceutical Co., Ltd. in the openFDA NDC Directory, most often as powder; injection, powder, for solution; injection, powder, lyophilized, for solution. 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.