Catalent Indiana L L C

FDA Filings

This page includes the latest FDA filings for Catalent Indiana L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3005949964
FEI Number3005949964
NameCATALENT INDIANA, LLC
Owner & OperatorCatalent Indiana, LLC
Contact Address1300 S. Patterson Dr. PO BOX 970
Bloomington IN 47402 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1300 S Patterson Dr
Bloomington, IN 47403 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device
Company
DeviceDate
sanofi-aventis U.S. LLC, Regeneron Pharmaceuticals, Inc., Sanofi-Winthrop Industrie, Sanofi-Aventis Deutschland GmbH, Regeneron Ireland Designated Activity Company
Prescription Medication2024-04-24
Dyax Corp., Rentschler Biopharma SE, Catalent Indiana, LLC
Prescription Medication2024-04-18
Regeneron Pharmaceuticals, Inc., WuXi Advanced Therapies Inc., WuXi AppTec, BioReliance, Nitto, Sharp Corporation, Regn Ireland DAC, Catalent Indiana, LLC
Prescription Medication2024-04-15
Regeneron Pharmaceuticals, Inc., WuXi Advanced Therapies Inc., WuXi AppTec, BioReliance, Nitto, Sharp Corporation, Regn Ireland DAC, Catalent Indiana, LLC
Prescription Medication2024-03-05
Regeneron Pharmaceuticals, Inc., WuXi Advanced Therapies Inc., WuXi AppTec, BioReliance, Nitto, Sharp Corporation, Regn Ireland DAC, Catalent Indiana, LLC
Prescription Medication2024-03-02
sanofi-aventis U.S. LLC, Regeneron Pharmaceuticals, Inc., Sanofi-Winthrop Industrie, Sanofi-Aventis Deutschland GmbH, Regeneron Ireland Designated Activity Company
Prescription Medication2024-02-07
sanofi-aventis U.S. LLC, Regeneron Pharmaceuticals, Inc., Sanofi-Winthrop Industrie, Sanofi-Aventis Deutschland GmbH, Regeneron Ireland Designated Activity Company
Prescription Medication2024-01-25
Regeneron Pharmaceuticals, Inc., WuXi Advanced Therapies Inc., WuXi AppTec, BioReliance, Nitto, Sharp Corporation, Regn Ireland DAC, Catalent Indiana, LLC
Prescription Medication2024-01-05
LEO Pharma Inc., Catalent Indiana, LLC., Astra Zeneca Pharmaceuticals LP, LEO Pharma A/S
Prescription Medication2023-12-19
Catalent Indiana, LLC
Other Medication2023-12-08
Janssen Biotech, Inc., Eurofins Lancaster Laboratories, Inc, Charles River Laboratories, Bioreliance Corporation, Catalent Indiana, LLC, Biogen (Denmark) Manufacturing ApS, Janssen Biologics B.V., Cilag AG, Janssen Vaccines Corp., Janssen Sciences Ireland UC
Prescription Medication2023-11-29
sanofi-aventis U.S. LLC, Regeneron Pharmaceuticals, Inc., Sanofi-Winthrop Industrie, Sanofi-Aventis Deutschland GmbH, Regeneron Ireland Designated Activity Company
Prescription Medication2023-10-26
sanofi-aventis U.S. LLC, Regeneron Pharmaceuticals, Inc., Sanofi-Winthrop Industrie, Sanofi-Aventis Deutschland GmbH, Regeneron Ireland Designated Activity Company
Prescription Medication2023-10-11
Catalent Indiana, LLC
Prescription Medication2023-10-07
Moderna US, Inc., ModernaTX, Inc., Catalent Indiana, LLC, Rovi Pharma Industrial Services S.A., Catalent Anagni S.R.L., Patheon Manufacturing Services, LLC
Other Medication2023-10-06
Catalent Indiana, LLC
Other Medication2023-10-05
Catalent Indiana, LLC
Other Medication2023-10-03
Catalent Indiana, LLC
Other Medication2023-09-27
Moderna US, Inc., ModernaTX, Inc., Catalent Indiana, LLC, Rovi Pharma Industrial Services S.A., Catalent Anagni S.R.L., Patheon Manufacturing Services, LLC
Other Medication2023-09-13
Moderna US, Inc., ModernaTX, Inc., Catalent Indiana, LLC, Rovi Pharma Industrial Services S.A., Catalent Anagni S.R.L., Patheon Manufacturing Services, LLC
Other Medication2023-09-01
Janssen Biotech, Inc., Eurofins Lancaster Laboratories, Inc, Charles River Laboratories, Bioreliance Corporation, Catalent Indiana, LLC, Biogen (Denmark) Manufacturing ApS, Janssen Biologics B.V., Cilag AG, Janssen Vaccines Corp., Janssen Sciences Ireland UC
Prescription Medication2023-08-01
sanofi-aventis U.S. LLC, Regeneron Pharmaceuticals, Inc., Sanofi-Winthrop Industrie, Sanofi-Aventis Deutschland GmbH, Regeneron Ireland Designated Activity Company
Prescription Medication2023-07-28
Janssen Biotech, Inc., Eurofins Lancaster Laboratories, Inc, Charles River Laboratories, Bioreliance Corporation, Catalent Indiana, LLC, Biogen (Denmark) Manufacturing ApS, Janssen Biologics B.V., Cilag AG, Janssen Vaccines Corp., Janssen Sciences Ireland UC
Prescription Medication2023-07-28
Horizon Therapeutics USA, Inc.
Prescription Medication2023-07-26
Catalent Indiana, LLC
Prescription Medication2023-07-07
Catalent Indiana, LLC
Prescription Medication2023-07-07
Catalent Indiana, LLC
Prescription Medication2023-06-23
Catalent Indiana, LLC
Prescription Medication2023-06-15
Janssen Biotech, Inc., Eurofins Lancaster Laboratories, Inc, Charles River Laboratories, Bioreliance Corporation, Catalent Indiana, LLC, Biogen (Denmark) Manufacturing ApS, Janssen Biologics B.V., Cilag AG, Janssen Vaccines Corp., Janssen Sciences Ireland UC
Prescription Medication2023-05-27
LEO Pharma Inc., Catalent Indiana, LLC., Astra Zeneca Pharmaceuticals LP, LEO Pharma A/S
Prescription Medication2023-05-25
Moderna US, Inc., ModernaTX, Inc., Lonza Biologics, Inc., Catalent Indiana, LLC, Baxter Pharmaceutical Solutions, LLC
Other Medication2023-05-24
Regeneron Pharmaceuticals, Inc., WuXi Advanced Therapies Inc., WuXi AppTec, BioReliance, Nitto, Sharp Corporation, Regn Ireland DAC, Catalent Indiana, LLC
Prescription Medication2023-05-05
Catalent Indiana, LLC
Prescription Medication2023-05-05
Moderna US, Inc., ModernaTX, Inc., Catalent Indiana, LLC, Patheon Manufacturing Services, LLC
Other Medication2023-05-04
Horizon Therapeutics USA, Inc.
Prescription Medication2023-04-21
Janssen Products, LP, Janssen, Jannsen Biologics B.V., Grand River Aseptic Manufacturing, Inc., Emergent Manufacturing Operations Baltimore LLC, Packaging Coordinators, LLC, Catalent Indiana, LLC
Other Medication2023-03-17
sanofi-aventis U.S. LLC, Regeneron Pharmaceuticals, Inc., Sanofi-Winthrop Industrie, Sanofi-Aventis Deutschland GmbH, Regeneron Ireland Designated Activity Company
Prescription Medication2023-02-19
Dyax Corp., Rentschler Biopharma SE, Catalent Indiana, LLC
Prescription Medication2023-02-17
Moderna US, Inc., ModernaTX, Inc., Catalent Indiana, LLC, Patheon Manufacturing Services, LLC
Other Medication2023-02-09
Moderna US, Inc., ModernaTX, Inc., Catalent Indiana, LLC, Patheon Manufacturing Services, LLC
Other Medication2023-01-29
Moderna US, Inc., ModernaTX, Inc., Catalent Indiana, LLC, Patheon Manufacturing Services, LLC
Other Medication2023-01-27
Moderna US, Inc., ModernaTX, Inc., Lonza Biologics, Inc., Catalent Indiana, LLC, Baxter Pharmaceutical Solutions, LLC
Other Medication2023-01-18
Flexion Therapeutics, Inc., Packaging Coordinators, LLC (PCI), Catalent Indiana, LLC, Synergy Health Sterilisation UK Ltd, Patheon UK Limited, Farmabios S.p.A., Alcami Carolinas Corporation
Prescription Medication2023-01-01
Janssen Biotech, Inc., Eurofins Lancaster Laboratories, Inc, Charles River Laboratories, Bioreliance Corporation, Catalent Indiana, LLC, Biogen (Denmark) Manufacturing ApS, Janssen Biologics B.V., Cilag AG, Janssen Vaccines Corp., Janssen Sciences Ireland UC
Prescription Medication2022-12-24
BioMarin Pharmaceutical Inc., Catalent Indiana, LLC
Prescription Medication2022-12-23
Dyax Corp., Rentschler Biopharma SE, Catalent Indiana, LLC
Prescription Medication2022-12-23
Horizon Therapeutics USA, Inc.
Prescription Medication2022-12-17
Moderna US, Inc., ModernaTX, Inc., Catalent Indiana, LLC
Other Medication2022-12-17
LEO Pharma Inc., Catalent Indiana, LLC., Astra Zeneca Pharmaceuticals LP, LEO Pharma A/S
Prescription Medication2022-12-09
sanofi-aventis U.S. LLC, Regeneron Pharmaceuticals, Inc., Sanofi-Winthrop Industrie, Sanofi-Aventis Deutschland GmbH, Regeneron Ireland Designated Activity Company
Prescription Medication2022-11-12
Regeneron Pharmaceuticals, Inc., WuXi Advanced Therapies Inc., WuXi AppTec, BioReliance, Nitto, Sharp Corporation, Regn Ireland DAC, Catalent Indiana, LLC
Prescription Medication2022-11-12
Catalent Indiana, LLC
Prescription Medication2022-11-10
Moderna US, Inc., ModernaTX, Inc., Lonza Biologics, Inc., Catalent Indiana, LLC, Baxter Pharmaceutical Solutions, LLC
Other Medication2022-11-10
sanofi-aventis U.S. LLC, Regeneron Pharmaceuticals, Inc., Sanofi-Winthrop Industrie, Sanofi-Aventis Deutschland GmbH, Regeneron Ireland Designated Activity Company
Prescription Medication2022-11-09
Moderna US, Inc., ModernaTX, Inc., Catalent Indiana, LLC, Patheon Manufacturing Services, LLC
Other Medication2022-11-08
Janssen Biotech, Inc., Eurofins Lancaster Laboratories, Inc, Charles River Laboratories, Bioreliance Corporation, Catalent Indiana, LLC, Biogen (Denmark) Manufacturing ApS, Janssen Biologics B.V., Cilag AG, Janssen Vaccines Corp., Janssen Sciences Ireland UC
Prescription Medication2022-11-08
Catalent Indiana, LLC
Prescription Medication2022-11-01
Catalent Indiana, LLC
Prescription Medication2022-10-29
Moderna US, Inc., ModernaTX, Inc., Catalent Indiana, LLC, Patheon Manufacturing Services, LLC
Other Medication2022-10-27
Catalent Indiana, LLC
Prescription Medication2022-10-21
sanofi-aventis U.S. LLC, Regeneron Pharmaceuticals, Inc., Sanofi-Winthrop Industrie, Sanofi-Aventis Deutschland GmbH, Regeneron Ireland Designated Activity Company
Prescription Medication2022-10-05
Moderna US, Inc., ModernaTX, Inc., Catalent Indiana, LLC
Other Medication2022-09-27
Moderna US, Inc., ModernaTX, Inc., Lonza Biologics, Inc., Catalent Indiana, LLC, Baxter Pharmaceutical Solutions, LLC
Other Medication2022-09-24
Catalent Indiana, LLC
Prescription Medication2022-09-22
Moderna US, Inc., ModernaTX, Inc., Catalent Indiana, LLC, Patheon Manufacturing Services, LLC
Other Medication2022-09-20
Moderna US, Inc., ModernaTX, Inc., Catalent Indiana, LLC, Patheon Manufacturing Services, LLC
Other Medication2022-09-14
Moderna US, Inc., ModernaTX, Inc., Catalent Indiana, LLC, Patheon Manufacturing Services, LLC
Other Medication2022-09-11
sanofi-aventis U.S. LLC, Regeneron Pharmaceuticals, Inc., Sanofi-Winthrop Industrie, Sanofi-Aventis Deutschland GmbH, Regeneron Ireland Designated Activity Company
Prescription Medication2022-08-12
Moderna US, Inc., ModernaTX, Inc., Catalent Indiana, LLC, Patheon Manufacturing Services, LLC
Other Medication2022-08-04
LEO Pharma Inc., Catalent Indiana, LLC., Astra Zeneca Pharmaceuticals LP, LEO Pharma A/S
Prescription Medication2022-08-02
Moderna US, Inc., ModernaTX, Inc., Lonza Biologics, Inc., Catalent Indiana, LLC, Baxter Pharmaceutical Solutions, LLC
Other Medication2022-07-06
Moderna US, Inc., ModernaTX, Inc., Catalent Indiana, LLC, Patheon Manufacturing Services, LLC
Other Medication2022-07-01
sanofi-aventis U.S. LLC, Regeneron Pharmaceuticals, Inc., Sanofi-Winthrop Industrie, Sanofi-Aventis Deutschland GmbH, Regeneron Ireland Designated Activity Company
Prescription Medication2022-06-28
Moderna US, Inc., ModernaTX, Inc., Catalent Indiana, LLC, Patheon Manufacturing Services, LLC
Other Medication2022-06-26
Moderna US, Inc., ModernaTX, Inc., Lonza Biologics, Inc., Catalent Indiana, LLC, Baxter Pharmaceutical Solutions, LLC
Other Medication2022-06-26
Moderna US, Inc., ModernaTX, Inc., Catalent Indiana, LLC, Patheon Manufacturing Services, LLC
Other Medication2022-06-23
sanofi-aventis U.S. LLC, Regeneron Pharmaceuticals, Inc., Sanofi-Winthrop Industrie, Sanofi-Aventis Deutschland GmbH, Regeneron Ireland Designated Activity Company
Prescription Medication2022-06-14
sanofi-aventis U.S. LLC, Regeneron Pharmaceuticals, Inc., Sanofi-Winthrop Industrie, Sanofi-Aventis Deutschland GmbH, Regeneron Ireland Designated Activity Company
Prescription Medication2022-05-28
LEO Pharma Inc., Catalent Indiana, LLC., Astra Zeneca Pharmaceuticals LP, LEO Pharma A/S
Prescription Medication2022-05-14
Catalent Indiana, LLC, ModernaTX, Inc.
Other Medication2022-05-12
Janssen Products, LP, Janssen, Jannsen Biologics B.V., Grand River Aseptic Manufacturing, Inc., Emergent Manufacturing Operations Baltimore LLC, Packaging Coordinators, LLC, Catalent Indiana, LLC
Other Medication2022-05-12
sanofi-aventis U.S. LLC, Regeneron Pharmaceuticals, Inc., Sanofi-Winthrop Industrie, Sanofi-Aventis Deutschland GmbH, Regeneron Ireland Designated Activity Company
Prescription Medication2022-04-27
Catalent Indiana, LLC, ModernaTX, Inc.
Other Medication2022-04-24
Moderna US, Inc., ModernaTX, Inc., Lonza Biologics, Inc., Catalent Indiana, LLC, Baxter Pharmaceutical Solutions, LLC
Other Medication2022-04-22
Janssen Biotech, Inc., Eurofins Lancaster Laboratories, Inc, Charles River Laboratories, Bioreliance Corporation, Catalent Indiana, LLC, Biogen (Denmark) Manufacturing ApS, Janssen Biologics B.V., Cilag AG, Janssen Vaccines Corp., Janssen Sciences Ireland UC
Prescription Medication2022-04-22
Moderna US, Inc., ModernaTX, Inc., Catalent Indiana, LLC, Patheon Manufacturing Services, LLC
Other Medication2022-04-20
Moderna US, Inc., ModernaTX, Inc., Catalent Indiana, LLC, Patheon Manufacturing Services, LLC
Other Medication2022-04-20
Moderna US, Inc., ModernaTX, Inc., Lonza Biologics, Inc., Catalent Indiana, LLC, Baxter Pharmaceutical Solutions, LLC
Other Medication2022-04-12
Moderna US, Inc., ModernaTX, Inc., Lonza Biologics, Inc., Catalent Indiana, LLC, Baxter Pharmaceutical Solutions, LLC
Other Medication2022-04-09
Regeneron Pharmaceuticals, Inc., Catalent Indiana, LLC, Integrated commercial solutions, LLC, Regeneron Pharmaceuticals, Inc, EMERGENT BIOSOLUTIONS
Prescription Medication2022-04-08
Catalent Indiana, LLC
SPIKEVAX2022-04-01
LEO Pharma Inc., Catalent Indiana, LLC., Astra Zeneca Pharmaceuticals LP, LEO Pharma A/S
Prescription Medication2022-03-02
Dyax Corp., Rentschler Biopharma SE, Catalent Indiana, LLC
Prescription Medication2022-02-19
Horizon Therapeutics USA, Inc.
Prescription Medication2022-02-18
Moderna US, Inc., ModernaTX, Inc., Lonza Biologics, Inc., Catalent Indiana, LLC, Baxter Pharmaceutical Solutions, LLC
Other Medication2022-02-12
Regeneron Pharmaceuticals, Inc., Catalent Indiana, LLC, Integrated commercial solutions, LLC, Regeneron Pharmaceuticals, Inc, EMERGENT BIOSOLUTIONS
Prescription Medication2022-02-04
Janssen Products, LP, Janssen, Jannsen Biologics B.V., Grand River Aseptic Manufacturing, Inc., Emergent Manufacturing Operations Baltimore LLC, Packaging Coordinators, LLC, Catalent Indiana, LLC
Other Medication2022-02-03
Moderna US, Inc., ModernaTX, Inc., Lonza Biologics, Inc., Catalent Indiana, LLC, Baxter Pharmaceutical Solutions, LLC
Other Medication2022-01-29
Janssen Biotech, Inc., Eurofins Lancaster Laboratories, Inc, Charles River Laboratories, Bioreliance Corporation, Catalent Indiana, LLC, Biogen (Denmark) Manufacturing ApS, Janssen Biologics B.V., Cilag AG, Janssen Vaccines Corp., Janssen Sciences Ireland UC
Prescription Medication2022-01-29
Horizon Therapeutics USA, Inc.
Prescription Medication2022-01-26
Janssen Products, LP, Janssen, Jannsen Biologics B.V., Grand River Aseptic Manufacturing, Inc., Emergent Manufacturing Operations Baltimore LLC, Packaging Coordinators, LLC, Catalent Indiana, LLC
Other Medication2022-01-13
Catalent Indiana, LLC
2020-12-21
Catalent Indiana, LLC
2020-12-21
Catalent Indiana, LLC
2020-10-14
Catalent Indiana, LLC
2019-08-12
Catalent Indiana, LLC
2018-10-30
Catalent Indiana, LLC
2018-09-28
Catalent Indiana, LLC
2018-09-28
Catalent Indiana, LLC
2018-08-24
Catalent Indiana, LLC
2018-08-24
Catalent Indiana, LLC
2018-08-22
Catalent Indiana, LLC
2018-08-22
Catalent Indiana, LLC
2018-08-22
Catalent Indiana, LLC
2018-08-22
Catalent Indiana, LLC
2017-10-06
CATALENT INDIANA, LLC
Sydney IVF Gamete Buffer2017-05-18
CATALENT INDIANA, LLC
Sydney IVF Culture Oil2017-05-12
Catalent Indiana, LLC
2017-03-03
CATALENT INDIANA, LLC
Sydney IVF Sperm Cryopreservation Buffer2016-12-27
CATALENT INDIANA, LLC
Cook Sydney IVF Follicle Flushing Buffer, Cook Sydney IVF Oocyte Wash Buffer, Cook Sydney IVF Fertilization Medium, Cook2016-12-27
CATALENT INDIANA, LLC
Sydney IVF Embryo Biopsy Medium2016-12-27
CATALENT INDIANA, LLC
Cook IVF Sperm Buffer, Cook IVF Sperm Medium, Cook IVF Sperm Gradient Kit2016-12-27
CATALENT INDIANA, LLC
Sydney IVF Blastocyst Cryopreservation Kit and Sydney IVF Blastocyst Thaw Kit2016-12-27
CATALENT INDIANA, LLC
Cook IVF Cryopreservation Kit and the Cook IVF Thaw Kit2016-12-27
CATALENT INDIANA, LLC
Sydney IVF PVP2016-12-27
CATALENT INDIANA, LLC
Sydney IVF Hyaluronidase2016-12-27
CATALENT INDIANA, LLC
Cook Sydney IVF Blastocyst Vitrification Kit, Cook Sydney IVF Blastocyst Warming Kit2016-12-27
Catalent Indiana, LLC
2016-09-19
Catalent Indiana, LLC
2016-09-19
Catalent Indiana, LLC
2014-10-16

Similar & Related FDA Registered Companies

Related Finance Registrations
CAGE Code6VE15CATALENT INDIANA, LLC
S.A.M. Registration6VE15 [172209277]CATALENT INDIANA, LLC
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020091830663Genova,Italy -> New York/Newark Area, Newark, New JerseySYRINGE EZ-FILL 46 BOXES ON 25 PALLETS HS-CODE 9018319025 PKG
2020091830664Genova,Italy -> New York/Newark Area, Newark, New JerseySYRINGE EZ-FILL 78 BOXES ON 24 PALLETS HS-CODE 9018319024 PKG
2020091639747Genova,Italy -> New York/Newark Area, Newark, New JerseySYRINGE EZ-FILL 46 BOXES ON 25 PALLETS HS-CODE 9018319025 PKG
2020091639748Genova,Italy -> New York/Newark Area, Newark, New JerseySYRINGE EZ-FILL 78 BOXES ON 24 PALLETS HS-CODE 9018319024 PKG
2020091482353Genova,Italy -> New York/Newark Area, Newark, New JerseySYRINGE EZ-FILL 46 BOXES ON 25 PALLETS HS-CODE 9018319025 PKG
2020091498579Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia.11 PCS
2020091498579Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia.11 PCS
2020091498579Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia.11 PCS
2020091498579Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia1 ONE OPTIMA SVRINQE-FILLINQ LINE WITH M P ISOLATOR, COMPLETE WITH ACCESSONES PR-261511 PCS
2020091498579Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia.11 PCS
2020091482354Genova,Italy -> New York/Newark Area, Newark, New JerseySYRINGE EZ-FILL 78 BOXES ON 24 PALLETS HS-CODE 9018319024 PKG
2020090941758Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia1ST PARTIAL SHIPMENT OF WMR2400 AND SHT-15 I NCL. ELECTRICAL CABINETS, COMPLETE WITH ACCES6 PCS
2020090941758Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia.6 PCS
2020090941758Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia.6 PCS
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.