Register entry

Catalent Indiana, LLC

Data as of · How to read this entry

Registered sites
1
Active NDC listings
27
Live patents
0
Countries
1
Base
United States
Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1Labelling1Finished drug manufacture1Packaging1
Sites

Registered establishments

1
EstablishmentAddressRegistered forFEI / DUNS
Catalent Indiana, LLC1300 S. Patterson Drive, Bloomington, Indiana (IN) 47403, United States (USA)Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging3005949964172209277
Catalogue

Drug listings by form and route

27

27 active NDC listings: 17 human prescription drug, 9 drug for further processing, 1 bulk ingredient. By marketing category: DRUG FOR FURTHER PROCESSING 23, EXPORT ONLY 3, BULK INGREDIENT 1.

Dosage formNDCs
injection, solution17
injection7
injection, powder, lyophilized, for solution2
solution1
RouteNDCs
Labeller name on the listingNDCs
catalent indiana, llc27
Catalogue

Marketed products

27
BrandGeneric nameForm / routeNDC
-Afliberceptinjection, solution61434-077EXPORT ONLY
-Benralizumabinjection, solution61434-066DRUG FOR FURTHER PROCESSING
-Cemiplimabinjection61434-021DRUG FOR FURTHER PROCESSING
-Diluentsolution61434-011DRUG FOR FURTHER PROCESSING
-Durvalumabinjection, solution61434-038DRUG FOR FURTHER PROCESSING
-Epinephrineinjection61434-040DRUG FOR FURTHER PROCESSING
-Epinephrineinjection61434-041DRUG FOR FURTHER PROCESSING
-Imetelstat sodiuminjection, powder, lyophilized, for solution61434-069DRUG FOR FURTHER PROCESSING
-Odronextamabinjection, solution61434-064EXPORT ONLY
-Odronextamabinjection, solution61434-072EXPORT ONLY
-adalimumabinjection, solution61434-020DRUG FOR FURTHER PROCESSING
-afliberceptinjection, solution61434-007DRUG FOR FURTHER PROCESSING
-afliberceptinjection, solution61434-062DRUG FOR FURTHER PROCESSING
-afliberceptinjection, solution61434-073DRUG FOR FURTHER PROCESSING
-afliberceptinjection, solution61434-074DRUG FOR FURTHER PROCESSING
-ansuvimab-zyklinjection61434-070DRUG FOR FURTHER PROCESSING
-ansuvimab-zyklinjection, powder, lyophilized, for solution61434-071DRUG FOR FURTHER PROCESSING
-atoltivimab, maftivimab, and odesivimabinjection, solution61434-052DRUG FOR FURTHER PROCESSING
-durvalumab injection, solutioninjection, solution61434-002DRUG FOR FURTHER PROCESSING
-eteplirseninjection61434-003DRUG FOR FURTHER PROCESSING
-eteplirseninjection61434-035DRUG FOR FURTHER PROCESSING
-nivolumabinjection, solution61434-075DRUG FOR FURTHER PROCESSING
-pozelimabinjection, solution61434-063DRUG FOR FURTHER PROCESSING
-rHuPH20injection61434-024BULK INGREDIENT
-ravulizumabinjection, solution61434-076DRUG FOR FURTHER PROCESSING
-semaglutideinjection, solution61434-067DRUG FOR FURTHER PROCESSING
-semaglutideinjection, solution61434-068DRUG FOR FURTHER PROCESSING
Neighbours

Registered in the same town

2
Compare

Comparable companies in United States

Enquiry

Common questions

Is Catalent Indiana, LLC FDA approved?
Catalent Indiana, LLC holds 1 FDA-registered establishment in the United States. 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 Catalent Indiana, LLC's drugs manufactured?
The FDA register lists Bloomington, IN. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
What drugs does Catalent Indiana, LLC make?
27 products are listed under Catalent Indiana, LLC in the openFDA NDC Directory, most often as injection, solution; injection; 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.