Register entry

Evonik Operations GmbH

Data as of · How to read this entry

Registered sites
11
Active NDC listings
18
Labeller names
2
Live patents
0
Countries
5
Base
Germany
Authorisation

Registered operations

Analytical testing6Active ingredient (API) manufacture5Finished drug manufacture2Packaging2sterilize1
Sites

Registered establishments

11
EstablishmentAddressRegistered forFEI / DUNS
Evonik Canada, Inc.Registrant: Evonik Operations GmbHVancouver Laboratories 8855 Northbrook Court, Burnaby, British Columbia V5J 5J1, Canada (CAN)Finished drug manufacture, Packaging, sterilize3012782320243203983
Evonik Rexim (Nanning) Pharmaceutical Co. Ltd.Registrant: Evonik Operations GmbH46 Wenjiang Road Wuming District, Nanning, Guangxi 530199, China (CHN)Active ingredient (API) manufacture3004268442544897861
Evonik Operations GmbHGutenbergstrasse 2, Dossenheim, Baden-Wuerttemberg 69221, Germany (DEU)Active ingredient (API) manufacture3002808332343170605
Evonik Operations GmbHRodenbacher Chaussee 4, Hanau, Hessen 63457, Germany (DEU)Active ingredient (API) manufacture3002806792332431464
Evonik Operations GmbHRegistrant: Evonik Industries AGRodenbacher Chaussee 4, Hanau, Hessen 63457, Germany (DEU)Analytical testing3008031763343230955
Evonik Operations GmbHRegistrant: Evonik Industries AGPaul-Baumann-Str. 1, Marl, Nordrhein-Westfalen 45764, Germany (DEU)Analytical testing3002911044313136733
Evonik Industries AGArthur Imhausen Strasse 92, Witten, North Rhine-Westphalia 58453, Germany (DEU)Analytical testing3008756383341517297
Evonik Rexim S.A.S.Registrant: Evonik Operations GmbH33 Rue De Verdun, Ham, Picardie 80400, France (FRA)Active ingredient (API) manufacture3002807994275258960
Evonik CorporationRegistrant: Evonik Operations GmbHBirmingham Laboratories 750 Lakeshore Parkway, Birmingham, Alabama (AL) 35211, United States (USA)Analytical testing, Finished drug manufacture, Packaging3012757951016858345
Evonik CorporationRegistrant: Evonik Operations GmbHTippecanoe Laboratories, 1650 Lilly Rd, Lafayette, Indiana (IN) 47909, United States (USA)Analytical testing, Active ingredient (API) manufacture1813682130890994
Evonik CorporationRegistrant: Evonik Industries AG2 Turner Place, Piscattaway, New Jersey (NJ) 08854, United States (USA)Analytical testing3006893691061101462
Catalogue

Drug listings by form and route

18

18 active NDC listings: 17 bulk ingredient, 1 drug for further processing. By marketing category: BULK INGREDIENT 15, EXPORT ONLY 2, DRUG FOR FURTHER PROCESSING 1.

Dosage formNDCs
powder14
liquid2
powder, for suspension1
suspension1
RouteNDCs
Labeller name on the listingNDCs
evonik corporation15
evonik operations gmbh3
Catalogue

Marketed products

18
BrandGeneric nameForm / routeNDC
-Alectinib HClpowder62128-0384BULK INGREDIENT
-Azelastine Hydrochloridepowder49274-1101BULK INGREDIENT
-Baloxavir marboxilpowder62128-0394BULK INGREDIENT
-Duloxetine hydrochloridepowder62128-0386BULK INGREDIENT
-Enzalutamidepowder62128-0388BULK INGREDIENT
-Gemcitabine hydrochloridepowder62128-0383EXPORT ONLY
-Linzagolix Cholinepowder62128-0395EXPORT ONLY
-Lorazepampowder52696-0002BULK INGREDIENT
-Lubabegron fumaratepowder62128-0393BULK INGREDIENT
-MGL-3196powder62128-0396BULK INGREDIENT
-Olanzapine Pamoatepowder, for suspension72309-004DRUG FOR FURTHER PROCESSING
-Ractopamine hydrochloric acidsuspension62128-0392BULK INGREDIENT
-Tadalafilpowder62128-0385BULK INGREDIENT
-Tilmicosinpowder62128-0390BULK INGREDIENT
-Tilmicosin Aqueousliquid62128-0389BULK INGREDIENT
-Tylosin Intermediateliquid62128-0391BULK INGREDIENT
-Vonoprazan Fumaratepowder52696-0010BULK INGREDIENT
-Vonoprazan Fumaratepowder62128-0397BULK INGREDIENT
Neighbours

Registered in the same town

9
Compare

Comparable companies in Germany

Enquiry

Common questions

Is Evonik Operations GmbH FDA approved?
Evonik Operations GmbH holds 11 FDA-registered establishments across 5 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 Evonik Operations GmbH's drugs manufactured?
At registered sites in Canada, China, Germany, France, the United States. The FDA register lists Burnaby; Nanning; Dossenheim; Hanau; Marl; Witten, and 4 more. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture, packaging, sterilize.
What drugs does Evonik Operations GmbH make?
18 products are listed under Evonik Operations GmbH in the openFDA NDC Directory, most often as powder; liquid; powder, for suspension. 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.