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19 Dec 2025
// FIERCE PHARMA
https://www.fiercepharma.com/manufacturing/fda-outlined-concerns-elevidys-manufacturing-catalents-maryland-manufacturing-sites

17 Dec 2025
// FIERCE PHARMA
https://www.fiercepharma.com/manufacturing/novo-gets-fda-warning-letter-troubled-indiana-site-formerly-owned-catalent

02 Dec 2025
// BIOSPACE
https://www.biospace.com/business/biotechs-secure-alternative-fill-finish-capacity-amid-scrutiny-of-novo-site

04 Nov 2025
// BUSINESSWIRE
https://www.businesswire.com/news/home/20251104076968/en/Catalents-SMARTag-ADC-Pipeline-and-New-Enhanced-Conjugates-Offering-Featured-at-16th-World-ADC-San-Diego

04 Nov 2025
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2025/11/04/3180798/18623/en/Lisata-Therapeutics-Highlights-Positive-Preclinical-Data-of-Certepetide-as-Part-of-Antibody-Drug-Conjugate-Combinations-as-Reported-by-Licensing-Partner-Catalent.html

28 Oct 2025
// BUSINESSWIRE
https://www.businesswire.com/news/home/20251027751926/en/Catalent-Debuts-New-Corporate-Brand-Elevating-Customer-Service-Excellence-by-Championing-the-Missions-that-Matter
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DMF Number : 15275
Submission : 2001-02-02
Status : Inactive
Type : II

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DMF Number : 15520
Submission : 2001-06-29
Status : Inactive
Type : II

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DMF Number : 22207
Submission : 2008-11-21
Status : Inactive
Type : II

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DMF Number : 15552
Submission : 2001-07-27
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DMF Number : 13060
Submission : 1998-07-07
Status : Inactive
Type : II

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DMF Number : 25289
Submission : 2011-09-12
Status : Inactive
Type : II

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DMF Number : 17686
Submission : 2004-09-05
Status : Inactive
Type : II

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DMF Number : 16974
Submission : 2003-11-20
Status : Inactive
Type : II

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DMF Number : 15564
Submission : 2001-08-02
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DMF Number : 15533
Submission : 2001-07-13
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Registration Number : 302MF10030
Registrant's Address : 1300 South Patterson Drive, Bloomington, Indiana 47403 USA
Initial Date of Registration : 2020-02-20
Latest Date of Registration : 2025-03-26

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JDMF
Registration Number : 307MF10071
Registrant's Address : 1180 E. Ellsworth Rd, Ann Arbor, MI 48108, USA
Initial Date of Registration : 2025-06-18
Latest Date of Registration : 2025-06-18

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Through the licensing deal, an undisclosed antibody-drug conjugate for cancer is being advanced.
Lead Product(s): Undisclosed
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: DiscoveryProduct Type: Antibody-drug Conjugate
Recipient: Lisata Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement October 08, 2025

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Lead Product(s) : Undisclosed
Therapeutic Area : Oncology
Highest Development Status : Discovery
Recipient : Lisata Therapeutics
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Lisata Therapeutics and Catalent Announce Global ]ADC License Agreement
Details : Through the licensing deal, an undisclosed antibody-drug conjugate for cancer is being advanced.
Product Name : Undisclosed
Product Type : Antibody-drug Conjugate
Upfront Cash : Undisclosed
October 08, 2025

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The upstream phase of the manufacturing process for Lumevoq, the Company’s gene therapy candidate for the rare mitochondrial disease LHON, has been successfully transferred to Catalent.
Lead Product(s): Lenadogene Nolparvovec
Therapeutic Area: Ophthalmology Brand Name: Lumevoq
Study Phase: Phase IIIProduct Type: Cell & Gene Therapy
Sponsor: GenSight Biologics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership June 26, 2025

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Lead Product(s) : Lenadogene Nolparvovec
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : GenSight Biologics
Deal Size : Undisclosed
Deal Type : Partnership
GenSight Biologics Announces Milestone in Manufacturing Partnership with Catalent
Details : The upstream phase of the manufacturing process for Lumevoq, the Company’s gene therapy candidate for the rare mitochondrial disease LHON, has been successfully transferred to Catalent.
Product Name : Lumevoq
Product Type : Cell & Gene Therapy
Upfront Cash : Undisclosed
June 26, 2025

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The collaboration aims to advnace the clinical development of Silexion's SIL-204, which is a next-generation siRNA candidate. It is being evaluated for KRAS-mutated cancers.
Lead Product(s): SIL-204
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: PreclinicalProduct Type: Oligonucleotide
Sponsor: Silexion Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration April 23, 2025

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Lead Product(s) : SIL-204
Therapeutic Area : Oncology
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Silexion Therapeutics
Deal Size : Undisclosed
Deal Type : Collaboration
Silexion Partners with Catalent on Advanced siRNA Development
Details : The collaboration aims to advnace the clinical development of Silexion's SIL-204, which is a next-generation siRNA candidate. It is being evaluated for KRAS-mutated cancers.
Product Name : Undisclosed
Product Type : Oligonucleotide
Upfront Cash : Undisclosed
April 23, 2025

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Lisata and Catalent will evaluate the combination of certepetide and the SMARTag ADC platform, dual-payload technology platform for the treatment of advanced solid tumors.
Lead Product(s): Undisclosed
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: PreclinicalProduct Type: Undisclosed
Recipient: Lisata Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement April 15, 2025

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Lead Product(s) : Undisclosed
Therapeutic Area : Oncology
Highest Development Status : Preclinical
Recipient : Lisata Therapeutics
Deal Size : Undisclosed
Deal Type : Agreement
Lisata Therapeutics Announces Research License with Catalent
Details : Lisata and Catalent will evaluate the combination of certepetide and the SMARTag ADC platform, dual-payload technology platform for the treatment of advanced solid tumors.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Undisclosed
April 15, 2025

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Under the agreement, Catalent Pharma will be responsible for the production of Jotrol (resveratrol) softgel capsules to support Jupiter’s upcoming Phase 2a clinical trial in Parkinson’s disease.
Lead Product(s): Resveratrol
Therapeutic Area: Neurology Brand Name: Jotrol
Study Phase: Phase IProduct Type: Plant Extract/Herbal
Sponsor: Jupiter Neurosciences
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement February 03, 2025

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Lead Product(s) : Resveratrol
Therapeutic Area : Neurology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Jupiter Neurosciences
Deal Size : Undisclosed
Deal Type : Agreement
Jupiter, Catalent Sign JOTROL Manufacturing Deal for Parkinson’s Phase 2a
Details : Under the agreement, Catalent Pharma will be responsible for the production of Jotrol (resveratrol) softgel capsules to support Jupiter’s upcoming Phase 2a clinical trial in Parkinson’s disease.
Product Name : Jotrol
Product Type : Plant Extract/Herbal
Upfront Cash : Undisclosed
February 03, 2025

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The partnership aims to support the development and manufacturing of Siren Biotechnology’s AAV immuno-gene therapies, being developed for the treatment of cancer.
Lead Product(s): Undisclosed
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: PreclinicalProduct Type: Undisclosed
Sponsor: Siren Biotechnology
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership May 08, 2024

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Lead Product(s) : Undisclosed
Therapeutic Area : Oncology
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Siren Biotechnology
Deal Size : Undisclosed
Deal Type : Partnership
Siren Biotechnology and Catalent Partner to Manufacture AAV Gene Therapies for Cancer
Details : The partnership aims to support the development and manufacturing of Siren Biotechnology’s AAV immuno-gene therapies, being developed for the treatment of cancer.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Undisclosed
May 08, 2024

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Under the agreement, Melt Pharmaceuticals will utilize Catalent’s proprietary Zydis® orally disintegrating tablet fast-dissolve technology with MELT-300 (midazolam), a sublingual, needle- and opioid-free patented formulation for procedural sedation during cataract surgery.
Lead Product(s): Midazolam,Ketamine Hydrochloride
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Controlled Substance
Sponsor: Melt Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement September 26, 2023

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Lead Product(s) : Midazolam,Ketamine Hydrochloride
Therapeutic Area : Neurology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Melt Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Details : Under the agreement, Melt Pharmaceuticals will utilize Catalent’s proprietary Zydis® orally disintegrating tablet fast-dissolve technology with MELT-300 (midazolam), a sublingual, needle- and opioid-free patented formulation for procedural sedation du...
Product Name : Undisclosed
Product Type : Controlled Substance
Upfront Cash : Undisclosed
September 26, 2023

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Under the agreement, Catalent has granted MindMed access to its Zydis technology for the development of MindMed’s lead candidate MM-120 (lysergide D-tartrate), which is currently in Phase 2 for generalized anxiety disorder.
Lead Product(s): Lysergide D-tartrate
Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Controlled Substance
Sponsor: Mind Medicine
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement August 03, 2023

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Lead Product(s) : Lysergide D-tartrate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Mind Medicine
Deal Size : Undisclosed
Deal Type : Licensing Agreement
MindMed Announces Exclusive License Agreement with Catalent for its Patented Zydis® Fast-Dissolve...
Details : Under the agreement, Catalent has granted MindMed access to its Zydis technology for the development of MindMed’s lead candidate MM-120 (lysergide D-tartrate), which is currently in Phase 2 for generalized anxiety disorder.
Product Name : Undisclosed
Product Type : Controlled Substance
Upfront Cash : Undisclosed
August 03, 2023

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Under the agreement, Catalent will manufacture Harm Reduction Therapeutics’ naloxone nasal spray, RiVive™, for the emergency treatment of known or suspected opioid overdose.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Brand Name: Rivive
Study Phase: Phase IIIProduct Type: Controlled Substance
Sponsor: Harm Reduction Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement March 23, 2023

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Lead Product(s) : Naloxone Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Harm Reduction Therapeutics
Deal Size : Undisclosed
Deal Type : Agreement
Details : Under the agreement, Catalent will manufacture Harm Reduction Therapeutics’ naloxone nasal spray, RiVive™, for the emergency treatment of known or suspected opioid overdose.
Product Name : Rivive
Product Type : Controlled Substance
Upfront Cash : Undisclosed
March 23, 2023

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The collaboration leads to the successful reformulation of an investigational, orally dosed small molecule in Grünenthal’s pipeline to improve its bioavailability. Phase 1 studies of the molecule will be supported by using the Catalent Xpress Pharmaceutics™ platform.
Lead Product(s): Undisclosed
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: PreclinicalProduct Type: Undisclosed
Sponsor: Grunenthal
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration March 15, 2023

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Lead Product(s) : Undisclosed
Therapeutic Area : Neurology
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Grunenthal
Deal Size : Undisclosed
Deal Type : Collaboration
Catalent and Grünenthal Announce Successful Collaboration to Facilitate Expedited Clinical Develo...
Details : The collaboration leads to the successful reformulation of an investigational, orally dosed small molecule in Grünenthal’s pipeline to improve its bioavailability. Phase 1 studies of the molecule will be supported by using the Catalent Xpress Pharmace...
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Undisclosed
March 15, 2023

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City/Region : Buenos Aires
Audit Date : 2025-07-08
Audit Type : On-Site
Country : U.S.A
City/Region : Winchester
Audit Date : 2023-09-12
Audit Type : On-Site
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Catalent Pharma Solutions is a supplier offers 111 products (APIs, Excipients or Intermediates).
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