Register entry

Daewoong Pharmaceutical Co., Ltd.

Data as of · How to read this entry

Registered sites
4
Active NDC listings
1
Live patents
0
Countries
2
Base
South Korea
Authorisation

Registered operations

Analytical testing4Active ingredient (API) manufacture2Labelling2Finished drug manufacture2Packaging2
Sites

Registered establishments

4
EstablishmentAddressRegistered forFEI / DUNS
DAEWOONG PHARMACEUTICAL (INDIA) PRIVATE LIMITEDRegistrant: DAEWOONG PHARMACEUTICAL INDIA PRIVATE LIMITEDPlot No. 5A, APIIC, Prashanth Nagar KUKATPALLY, Hyderabad, Telangana 500072, India (IND)Analytical testing3027666582876818291
Daewoong Pharmaceutical Co.,Ltd.Registrant: Daewoong Pharmaceutical Co., Ltd.1, Osongsaengmyeong 2-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do 28162, Korea, South (KOR)Analytical testing, Labelling, Finished drug manufacture, Packaging3013514300689851296
Daewoong Bio Inc.29, Jeyakdanji-ro, Hyangnam-Eup, Hwaseong-si, Gyeonggi-do 18608, Korea, South (KOR)Analytical testing, Active ingredient (API) manufacture3011083160557815704
Daewoong Pharmaceutical Co. Ltd.Registrant: Daewoong Pharmaceutical Co., Ltd.35-14, Jeyakgongdan 4-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do 18623, Korea, South (KOR)Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging3012333115688309579
Catalogue

Marketed products

1
BrandGeneric nameForm / routeNDC
-Ursodiol (Process IV)powder70294-103BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Neighbours

Registered in the same town

12
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Comparable companies in South Korea

Enquiry

Common questions

Is Daewoong Pharmaceutical Co., Ltd. FDA approved?
Daewoong Pharmaceutical Co., Ltd. holds 4 FDA-registered establishments across 2 countries. 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 Daewoong Pharmaceutical Co., Ltd.'s drugs manufactured?
At registered sites in India, South Korea. The FDA register lists Hyderabad; Chungcheongbuk-do 28162; Gyeonggi-do 18608; Gyeonggi-do 18623. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
What drugs does Daewoong Pharmaceutical Co., Ltd. make?
1 product is listed under Daewoong Pharmaceutical Co., Ltd. in the openFDA NDC Directory, most often as 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.