Register entry

Patheon Manufacturing Services LLC

Data as of · How to read this entry

Registered sites
19
Active NDC listings
318
Labeller names
10
Live patents
0
Countries
9
Base
United States
Authorisation

Registered operations

Analytical testing17Active ingredient (API) manufacture6Labelling11Finished drug manufacture15Packaging12sterilize3
Sites

Registered establishments

19
EstablishmentAddressRegistered forFEI / DUNS
Patheon Biologics Australia Pty LtdRegistrant: Patheon Manufacturing Services LLC37 Kent Street, Woolloongabba, Queensland 4102, Australia (AUS)Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging3010976475743194888
Patheon Austria GmbH & CoKGRegistrant: Patheon Manufacturing Services LLCSt.-Peter-Strasse 25, Linz, 4020, Austria (AUT)Analytical testing, Active ingredient (API) manufacture3002806853300398976
Patheon Inc.Registrant: Patheon Manufacturing Services LLC95 Market Dr, Milton, Ontario L9T 4Z7, Canada (CAN)Finished drug manufacture3047706967243370117
Patheon Inc.Registrant: Patheon Manufacturing Services LLC2100 Syntex Court, Mississauga, Ontario L5N 7K9, Canada (CAN)Analytical testing, Labelling, Finished drug manufacture, Packaging3000264888240769596
Patheon Inc.Registrant: Patheon Manufacturing Services LLC111 Consumers Drive, Whitby, Ontario L1N 5Z5, Canada (CAN)Analytical testing, Labelling, Finished drug manufacture, Packaging3003516812205475333
Patheon France S.A.SRegistrant: Patheon Manufacturing Services LLC40 Boulevard de Champaret, Bourgoin Jallieu, - 38 300, France (FRA)Analytical testing, Labelling, Finished drug manufacture, Packaging3004468553543127229
Patheon UK LimitedRegistrant: Patheon Manufacturing Services LLCKingfisher Drive, Swindon, Sn3 5bz, United Kingdom (GBR)Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize3002807216237710418
Thermo Fisher Scientific Cork LimitedRegistrant: Patheon Manufacturing Services LLCCurrabinny, Carrigaline, Cork P43 AY66, Ireland (IRL)Analytical testing, Active ingredient (API) manufacture1000170338985745028
Patheon Italia S.p.ARegistrant: Patheon Manufacturing Services LLC2� Trav. SX Via Morolense, 5, Ferentino, - 03013, Italy (ITA)Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize3004110157434078638
Patheon Italia S.p.A.Registrant: Patheon Manufacturing Services LLCViale Gian Battista Stucchi 110, Monza, - 20900, Italy (ITA)Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize3003065803338336589
Patheon Biologics B.V.Registrant: Patheon Manufacturing Services LLCZuiderweg 72/2, Groningen, AP 9744, Netherlands (NLD)Analytical testing, Active ingredient (API) manufacture3002608687419364153
Patheon Softgels B.V.Registrant: Patheon Manufacturing Services LLCDe Posthoornstraat 7, Tilburg, Tilburg 5048 AS, Netherlands (NLD)Analytical testing, Finished drug manufacture1000384811417524097
Patheon Pharmaceuticals Inc.Registrant: Patheon Manufacturing Services LLC2110 E Galbraith Rd., Cincinnati, Ohio (OH) 45237, United States (USA)Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging1510437005286822
Patheon Biologics LLC13600 Shoreline Drive, Earth City, Missouri (MO) 63045-1203, United States (USA)Finished drug manufacture3032073937119085689
Patheon Manufacturing Services LLC5900 Martin Luther King Jr. Highway, Greenville, North Carolina (NC) 27834, United States (USA)Analytical testing, Labelling, Finished drug manufacture, Packaging1018495079415560
Patheon Softgels Inc.Registrant: Patheon Manufacturing Services LLC4125 Premier Dr, High Point, North Carolina (NC) 27265, United States (USA)Analytical testing, Finished drug manufacture, Packaging3001451366002193829
Patheon Puerto Rico, Inc.Registrant: Patheon Manufacturing Services LLCState Road #670 Km. 2.7, Manati, Puerto Rico (PR) 00674, United States (USA)Analytical testing, Labelling, Finished drug manufacture, Packaging3003113148174050377
Patheon Manufacturing Services LLC1125 Pleasantview Ter, Ridgefield, New Jersey (NJ) 07657, United States (USA)Analytical testing, Labelling, Finished drug manufacture, Packaging2246315062331516
Patheon Biologics LLC4766 LaGuardia Drive, Saint Louis, Missouri (MO) 63134-3116, United States (USA)Analytical testing, Active ingredient (API) manufacture3003418999965750420
Catalogue

Drug listings by form and route

318

318 active NDC listings: 316 drug for further processing, 2 vaccine. By marketing category: DRUG FOR FURTHER PROCESSING 317, BLA 1.

Dosage formNDCs
tablet, film coated85
tablet54
capsule40
injection21
injection, powder, lyophilized, for solution14
solution14
tablet, coated13
injection, solution12
capsule, gelatin coated9
kit9
tablet, extended release7
tablet, film coated, extended release7
capsule, coated pellets4
granule, for suspension3
tablet, chewable3
RouteNDCs
intramuscular1
Labeller name on the listingNDCs
patheon inc.111
patheon manufacturing services llc99
patheon pharmaceuticals inc.40
patheon france s.a.s.26
patheon, inc.18
patheon france s.a.s17
patheon biologics llc3
patheon uk limited2
patheon biologics b.v.1
patheon france s.a.s1
Catalogue

Marketed products

319

Showing 150 of 319.

BrandGeneric nameForm / routeNDC
-.ALPHA.1-PROTEINASE INHIBITOR HUMANinjection63552-187DRUG FOR FURTHER PROCESSING
-.ALPHA.1-PROTEINASE INHIBITOR HUMANinjection63552-210DRUG FOR FURTHER PROCESSING
-.ALPHA.1-PROTEINASE INHIBITOR HUMANinjection63552-213DRUG FOR FURTHER PROCESSING
-ACETAZOLAMIDE SODIUMinjection, powder, lyophilized, for solution63552-116DRUG FOR FURTHER PROCESSING
-AFLIBERCEPT-JBVFinjection63552-281DRUG FOR FURTHER PROCESSING
-ALTEPLASEinjection, powder, lyophilized, for solution63552-041DRUG FOR FURTHER PROCESSING
-ANAGRELIDE HYDROCHLORIDEcapsule63552-005DRUG FOR FURTHER PROCESSING
-APREMILASTtablet, film coated66406-0240DRUG FOR FURTHER PROCESSING
-APREMILASTtablet, film coated66406-0241DRUG FOR FURTHER PROCESSING
-APREMILASTtablet, film coated66406-0242DRUG FOR FURTHER PROCESSING
-AVACOPANcapsule67651-0363DRUG FOR FURTHER PROCESSING
-AVACOPANcapsule67651-0364DRUG FOR FURTHER PROCESSING
-Adagrasibtablet, coated47049-043DRUG FOR FURTHER PROCESSING
-Avapritinibtablet, film coated63285-868DRUG FOR FURTHER PROCESSING
-Avapritinibtablet, film coated63285-869DRUG FOR FURTHER PROCESSING
-CARBAMAZEPINEtablet63552-060DRUG FOR FURTHER PROCESSING
-COLISTIMETHATE SODIUMinjection, powder, lyophilized, for solution63552-010DRUG FOR FURTHER PROCESSING
-Carfilzomibinjection, powder, lyophilized, for solution63552-009DRUG FOR FURTHER PROCESSING
-Carfilzomibinjection, powder, lyophilized, for solution63552-035DRUG FOR FURTHER PROCESSING
-Carfilzomibinjection, powder, lyophilized, for solution63552-214DRUG FOR FURTHER PROCESSING
-DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATEcapsule, extended release63552-129DRUG FOR FURTHER PROCESSING
-DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATEcapsule, extended release63552-130DRUG FOR FURTHER PROCESSING
-DEXTROMETHORPHAN HYDROBROMIDE and BUPROPION HYDROCHLORIDEtablet, multilayer, extended release66406-0336DRUG FOR FURTHER PROCESSING
-DEXTROMETHORPHAN HYDROBROMIDE and BUPROPION HYDROCHLORIDEtablet, multilayer, extended release66406-0467DRUG FOR FURTHER PROCESSING
-Darunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamidetablet, film coated63285-816DRUG FOR FURTHER PROCESSING
-EMTRICITABINEsolution66406-0209DRUG FOR FURTHER PROCESSING
-EPHEDRINE SULFATEinjection63552-282DRUG FOR FURTHER PROCESSING
-ERYTHROPOIETINsolution63552-135DRUG FOR FURTHER PROCESSING
-ERYTHROPOIETINsolution63552-136DRUG FOR FURTHER PROCESSING
-ERYTHROPOIETINsolution63552-137DRUG FOR FURTHER PROCESSING
-ERYTHROPOIETINsolution63552-138DRUG FOR FURTHER PROCESSING
-ERYTHROPOIETINsolution63552-139DRUG FOR FURTHER PROCESSING
-ERYTHROPOIETINsolution63552-140DRUG FOR FURTHER PROCESSING
-ERYTHROPOIETINsolution63552-141DRUG FOR FURTHER PROCESSING
-ESLICARBAZEPINE ACETATEtablet66406-0203DRUG FOR FURTHER PROCESSING
-ESLICARBAZEPINE ACETATEtablet66406-0204DRUG FOR FURTHER PROCESSING
-ESLICARBAZEPINE ACETATEtablet66406-0222DRUG FOR FURTHER PROCESSING
-ETANERCEPT, LICENSE HOLDER UNSPECIFIEDinjection, powder, lyophilized, for solution63552-102DRUG FOR FURTHER PROCESSING
-ETELCALCETIDE HYDROCHLORIDEsolution63552-029DRUG FOR FURTHER PROCESSING
-ETELCALCETIDE HYDROCHLORIDEsolution63552-030DRUG FOR FURTHER PROCESSING
-ETELCALCETIDE HYDROCHLORIDEsolution63552-031DRUG FOR FURTHER PROCESSING
-FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITEinjection63552-026DRUG FOR FURTHER PROCESSING
FLUZONE HIGH DOSE NORTHERN HEMISPHEREinfluenza a virus a/victoria/4897/2022 ivr-238 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/croatia/10136/rv/2023 (h3n2) antigen (formaldehyde inactivated), and influenza b virus b/michigan/01/2021 antigen (formaldehyde inactivated)injection, suspension, intramuscular63552-722BLA
-FOSAPREPITANT DIMEGLUMINEinjection, powder, lyophilized, for solution63552-011DRUG FOR FURTHER PROCESSING
-Famotidinetablet, film coated66406-0100DRUG FOR FURTHER PROCESSING
-Famotidinetablet, film coated66406-0101DRUG FOR FURTHER PROCESSING
-Famotidinetablet, film coated66406-0446DRUG FOR FURTHER PROCESSING
-GUANFACINE HYDROCHLORIDEtablet, extended release63552-021DRUG FOR FURTHER PROCESSING
-GUANFACINE HYDROCHLORIDEtablet, extended release63552-022DRUG FOR FURTHER PROCESSING
-GUANFACINE HYDROCHLORIDEtablet, extended release63552-023DRUG FOR FURTHER PROCESSING
-GUANFACINE HYDROCHLORIDEtablet, extended release63552-024DRUG FOR FURTHER PROCESSING
-IVABRADINE HYDROCHLORIDEtablet, film coated63552-044DRUG FOR FURTHER PROCESSING
-IVABRADINE HYDROCHLORIDEtablet, film coated63552-045DRUG FOR FURTHER PROCESSING
-Iloperidonekit63285-923DRUG FOR FURTHER PROCESSING
-LORATADINEtablet, chewable63552-038DRUG FOR FURTHER PROCESSING
-LORATADINE and pseudoephedrine sulfatetablet, film coated, extended release63552-039DRUG FOR FURTHER PROCESSING
-LORATADINE and pseudoephedrine sulfatetablet, film coated, extended release63552-040DRUG FOR FURTHER PROCESSING
-MELPHALAN HYDROCHLORIDEinjection, powder, lyophilized, for solution63552-076DRUG FOR FURTHER PROCESSING
-MESALAMINEcapsule63552-042DRUG FOR FURTHER PROCESSING
-MESALAMINEcapsule63552-043DRUG FOR FURTHER PROCESSING
-Milsaperidonekit63285-937DRUG FOR FURTHER PROCESSING
-Milsaperidonekit63285-938DRUG FOR FURTHER PROCESSING
-Milsaperidonekit63285-939DRUG FOR FURTHER PROCESSING
-Milsaperidonekit63285-940DRUG FOR FURTHER PROCESSING
-Minoxidiltablet66406-0045DRUG FOR FURTHER PROCESSING
-Minoxidiltablet66406-0046DRUG FOR FURTHER PROCESSING
-Montelukast Sodiumgranule63552-027DRUG FOR FURTHER PROCESSING
-NAXITAMABsolution, concentrate83266-0000DRUG FOR FURTHER PROCESSING
-Naxitamabinjection63552-209DRUG FOR FURTHER PROCESSING
-Nirogacestattablet, film coated47049-037DRUG FOR FURTHER PROCESSING
-Nirogacestattablet, film coated47049-038DRUG FOR FURTHER PROCESSING
-Nirsevimabinjection63552-207DRUG FOR FURTHER PROCESSING
-Nirsevimabinjection63552-208DRUG FOR FURTHER PROCESSING
-OXCARBAZEPINEtablet66406-0244DRUG FOR FURTHER PROCESSING
-OXCARBAZEPINEtablet66406-0245DRUG FOR FURTHER PROCESSING
-OXCARBAZEPINEtablet66406-0246DRUG FOR FURTHER PROCESSING
-OXYMORPHONE HYDROCHLORIDEtablet63552-090DRUG FOR FURTHER PROCESSING
-OXYMORPHONE HYDROCHLORIDEtablet63552-091DRUG FOR FURTHER PROCESSING
-OXYMORPHONE HYDROCHLORIDEtablet63552-092DRUG FOR FURTHER PROCESSING
-OXYMORPHONE HYDROCHLORIDEtablet63552-093DRUG FOR FURTHER PROCESSING
-OXYMORPHONE HYDROCHLORIDEtablet63552-094DRUG FOR FURTHER PROCESSING
-OXYMORPHONE HYDROCHLORIDEtablet63552-095DRUG FOR FURTHER PROCESSING
-OXYMORPHONE HYDROCHLORIDEtablet63552-096DRUG FOR FURTHER PROCESSING
-Omadacyclinetablet, film coated67651-0375DRUG FOR FURTHER PROCESSING
-Oteseconazolecapsule, gelatin coated66406-0334DRUG FOR FURTHER PROCESSING
-PRUCALOPRIDE SUCCINATEtablet, film coated67651-0330DRUG FOR FURTHER PROCESSING
-PRUCALOPRIDE SUCCINATEtablet, film coated67651-0331DRUG FOR FURTHER PROCESSING
-Peramivirsolution63552-077DRUG FOR FURTHER PROCESSING
-Pitolisant hydrochloridetablet, film coated47049-035DRUG FOR FURTHER PROCESSING
-Pitolisant hydrochloridetablet, film coated47049-036DRUG FOR FURTHER PROCESSING
-QUIZARTINIB DIHYDROCHLORIDEtablet, film coated47049-031DRUG FOR FURTHER PROCESSING
-QUIZARTINIB DIHYDROCHLORIDEtablet, film coated47049-032DRUG FOR FURTHER PROCESSING
-RALTEGRAVIR POTASSIUMgranule, for suspension67651-0274DRUG FOR FURTHER PROCESSING
-RALTEGRAVIR POTASSIUMtablet, chewable67651-0275DRUG FOR FURTHER PROCESSING
-RALTEGRAVIR POTASSIUMtablet, chewable67651-0276DRUG FOR FURTHER PROCESSING
-ROLAPITANT HYDROCHLORIDEtablet63285-828DRUG FOR FURTHER PROCESSING
-RUCAPARIB CAMSYLATEtablet, film coated63285-883DRUG FOR FURTHER PROCESSING
-RUCAPARIB CAMSYLATEtablet, film coated63285-884DRUG FOR FURTHER PROCESSING
-RUCAPARIB CAMSYLATEtablet, film coated63285-885DRUG FOR FURTHER PROCESSING
-RUXOLITINIBtablet63552-049DRUG FOR FURTHER PROCESSING
-RUXOLITINIBtablet63552-050DRUG FOR FURTHER PROCESSING
-RUXOLITINIBtablet63552-051DRUG FOR FURTHER PROCESSING
-RUXOLITINIBtablet63552-052DRUG FOR FURTHER PROCESSING
-RUXOLITINIBtablet63552-053DRUG FOR FURTHER PROCESSING
-Repotrectinibcapsule63285-905DRUG FOR FURTHER PROCESSING
-Repotrectinibcapsule63285-934DRUG FOR FURTHER PROCESSING
-Risperidoneinjection, powder, for solution63552-179DRUG FOR FURTHER PROCESSING
-Risperidoneinjection, powder, for solution63552-180DRUG FOR FURTHER PROCESSING
-SITAGLIPTIN PHOSPHATE and METFORMIN HYDROCHLORIDEtablet, film coated, extended release66406-0323DRUG FOR FURTHER PROCESSING
-SITAGLIPTIN PHOSPHATE and METFORMIN HYDROCHLORIDEtablet, film coated, extended release66406-0324DRUG FOR FURTHER PROCESSING
-SITAGLIPTIN PHOSPHATE and METFORMIN HYDROCHLORIDEtablet, film coated, extended release66406-0325DRUG FOR FURTHER PROCESSING
-SONIDEGIB PHOSPHATEcapsule63285-836DRUG FOR FURTHER PROCESSING
-Sugammadexinjection63552-003DRUG FOR FURTHER PROCESSING
-Sugammadexinjection63552-004DRUG FOR FURTHER PROCESSING
-Suvorexanttablet, film coated67651-0382DRUG FOR FURTHER PROCESSING
-Suvorexanttablet, film coated67651-0383DRUG FOR FURTHER PROCESSING
-Suvorexanttablet, film coated67651-0384DRUG FOR FURTHER PROCESSING
-Suvorexanttablet, film coated67651-0385DRUG FOR FURTHER PROCESSING
-TASIMELTEONcapsule67651-0307DRUG FOR FURTHER PROCESSING
-TENOFOVIR ALAFENAMIDE FUMARATEtablet63285-797DRUG FOR FURTHER PROCESSING
-TENOFOVIR DISOPROXIL FUMARATEtablet, coated63285-735DRUG FOR FURTHER PROCESSING
-TENOFOVIR DISOPROXIL FUMARATEtablet, coated63285-736DRUG FOR FURTHER PROCESSING
-TENOFOVIR DISOPROXIL FUMARATEtablet, coated63285-737DRUG FOR FURTHER PROCESSING
-TENOFOVIR DISOPROXIL FUMARATEtablet, coated66406-0103DRUG FOR FURTHER PROCESSING
-TETRAFERRIC TRICITRATE DECAHYDRATEtablet, coated66406-0280DRUG FOR FURTHER PROCESSING
-TOBRAMYCIN SULFATEinjection, powder, lyophilized, for solution63552-025DRUG FOR FURTHER PROCESSING
-TRASTUZUMABinjection, powder, lyophilized, for solution63552-037DRUG FOR FURTHER PROCESSING
-Teclistamabinjection63552-197DRUG FOR FURTHER PROCESSING
-Teclistamabinjection63552-198DRUG FOR FURTHER PROCESSING
-VIGABATRINpowder, for solution67651-0294DRUG FOR FURTHER PROCESSING
-Valbenazinecapsule47049-008DRUG FOR FURTHER PROCESSING
-Valbenazinecapsule47049-009DRUG FOR FURTHER PROCESSING
-Valbenazinecapsule47049-021DRUG FOR FURTHER PROCESSING
-Voxelotortablet, film coated66406-0301DRUG FOR FURTHER PROCESSING
-Voxelotortablet, film coated66406-0442DRUG FOR FURTHER PROCESSING
-WATERinjection63552-134DRUG FOR FURTHER PROCESSING
-Waterinjection63552-286DRUG FOR FURTHER PROCESSING
-Waterinjection63552-287DRUG FOR FURTHER PROCESSING
-Ziftomenibcapsule63285-928DRUG FOR FURTHER PROCESSING
-abiraterone acetatetablet47049-061DRUG FOR FURTHER PROCESSING
-abiraterone acetatetablet47049-062DRUG FOR FURTHER PROCESSING
-acoramidis hydrochloridetablet, film coated66406-0460DRUG FOR FURTHER PROCESSING
-adagrasibtablet, coated63285-894DRUG FOR FURTHER PROCESSING
-amifampridine phosphatetablet67651-0328DRUG FOR FURTHER PROCESSING
-arimoclomol citratecapsule47049-049DRUG FOR FURTHER PROCESSING
-arimoclomol citratecapsule47049-050DRUG FOR FURTHER PROCESSING
-arimoclomol citratecapsule47049-051DRUG FOR FURTHER PROCESSING
-arimoclomol citratecapsule47049-052DRUG FOR FURTHER PROCESSING
-armodafiniltablet63285-030DRUG FOR FURTHER PROCESSING
-armodafiniltablet63285-032DRUG FOR FURTHER PROCESSING
Neighbours

Registered in the same town

12
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Enquiry

Common questions

Is Patheon Manufacturing Services LLC FDA approved?
Patheon Manufacturing Services LLC holds 19 FDA-registered establishments across 9 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 Patheon Manufacturing Services LLC's drugs manufactured?
At registered sites in Australia, Austria, Canada, France, the United Kingdom, Ireland and 3 other countries. The FDA register lists Woolloongabba; Linz; Milton; Mississauga; Whitby; Bourgoin Jallieu, and 13 more. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, sterilize.
What drugs does Patheon Manufacturing Services LLC make?
319 products are listed under Patheon Manufacturing Services LLC in the openFDA NDC Directory, most often as tablet, film coated; tablet; capsule. 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.