Register entry

Viwit Pharmaceutical Co., Ltd.

Data as of · How to read this entry

Registered sites
3
Active NDC listings
5
Labeller names
2
Live patents
0
Countries
1
Base
China
Authorisation

Registered operations

Analytical testing3Active ingredient (API) manufacture1Labelling2Finished drug manufacture2Packaging2
Sites

Registered establishments

3
EstablishmentAddressRegistered forFEI / DUNS
Viwit Pharmaceutical Co., Ltd.389 West Shannan Road, Tengzhou Industrial Park, Shandong, China, Tengzhou, Shandong 277599, China (CHN)Analytical testing, Labelling, Finished drug manufacture, Packaging3008307561421161906
Viwit Pharmaceutical Co., Ltd.88 Weizhi Road, Tengzhou Biopharma Park, Shandong, China, Tengzhou, Shandong 277514, China (CHN)Analytical testing, Active ingredient (API) manufacture3009868618421281679
Viwit Pharmaceutical Co., Ltd.369 Shengong Road, Zaozhuang High-tech Park, Shandong, China, Zaozhuang, Shandong 277000, China (CHN)Analytical testing, Labelling, Finished drug manufacture, Packaging3006068789530756485
Catalogue

Drug listings by form and route

5

5 active NDC listings: 3 human prescription drug, 2 bulk ingredient. By marketing category: ANDA 3, BULK INGREDIENT 2.

Dosage formNDCs
injection3
powder2
RouteNDCs
intravenous3
Labeller name on the listingNDCs
viwit pharmaceutical co., ltd.3
viwit pharmaceutical co ltd2
Catalogue

Marketed products

5
BrandGeneric nameForm / routeNDC
-Efinaconazolepowder42337-410BULK INGREDIENT
-Varenicline Tartratepowder42337-401BULK INGREDIENT
gadobutrolgadobutrolinjection, intravenous42337-005ANDA
gadobutrolgadobutrolinjection, intravenous42337-006ANDA
gadobutrolgadobutrolinjection, intravenous42337-007ANDA
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Enquiry

Common questions

Is Viwit Pharmaceutical Co., Ltd. FDA approved?
Viwit Pharmaceutical Co., Ltd. holds 3 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 Viwit Pharmaceutical Co., Ltd.'s drugs manufactured?
The FDA register lists Tengzhou; Zaozhuang. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
What drugs does Viwit Pharmaceutical Co., Ltd. make?
5 products are listed under Viwit Pharmaceutical Co., Ltd. in the openFDA NDC Directory, most often as injection; powder. 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.