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Digital content
NEWS #PharmaBuzz
09 Dec 2025
// BUSINESSWIRE
https://www.businesswire.com/news/home/20251209571909/en/Tris-Pharma-Announces-FDA-Acceptance-of-NDA-for-Once-Nightly-Low-Sodium-Oxybate-Product-for-Narcolepsy-and-Idiopathic-Hypersomnia
20 Nov 2025
// FIERCE PHARMA
https://www.fiercepharma.com/pharma/pfizer-tris-pharma-ink-415m-deal-settle-adulterated-adhd-drug-allegations-texas
16 Oct 2025
// BUSINESSWIRE
https://www.businesswire.com/news/home/20251016627732/en/Tris-Pharma-Announces-Acceptance-of-New-Review-Article-Highlighting-Challenges-of-Treating-Moderate-to-Severe-Acute-Pain-with-Currently-Available-Drugs
28 Aug 2025
// BUSINESSWIRE
https://www.businesswire.com/news/home/20250828170321/en/Tris-Pharma-Showcases-a-Novel-Mechanism-of-Dual-NOPMOP-NMR-Agonism-for-the-Treatment-of-Moderate-to-Severe-Acute-Pain-and-Encores-Positive-Phase-3-Data-at-2025-Annual-PAINWeek-Meeting-in-Las-Vegas
27 Jun 2025
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219454
12 Jun 2025
// BUSINESSWIRE
https://www.businesswire.com/news/home/20250612665724/en/Tris-Pharma-to-Debut-Positive-Results-of-Intranasal-Snorting-Human-Abuse-Potential-Study-of-Cebranopadol-an-Investigational-First-In-Class-Oral-Dual-NMR-Agonist-for-the-Treatment-of-Moderate-to-Severe-Pain-at-the-2025-CPDD-Annual-Meeting
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Click Us!
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33626
Submission : 2019-11-04
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29361
Submission : 2015-07-17
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35599
Submission : 2021-02-19
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27314
Submission : 2013-07-26
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29687
Submission : 2015-11-03
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23870
Submission : 2010-07-20
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25909
Submission : 2012-04-18
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33094
Submission : 2018-09-11
Status : Active
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
Drugs in Development
Details:
Sodium Oxybate, a small molecule product targeting the GABAB receptor, shows promise in treating Cataplexy.
Lead Product(s): Sodium Oxybate
Therapeutic Area: Musculoskeletal Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 09, 2025
Lead Product(s) : Sodium Oxybate
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Tris Pharma's NDA for Low-Sodium Oxybate Product Accepted by FDA for Narcolepsy
Details : Sodium Oxybate, a small molecule product targeting the GABAB receptor, shows promise in treating Cataplexy.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 09, 2025
Details:
Clonidine is a Other Small Molecule drug candidate, which is currently being evaluated in Phase IV clinical studies for the treatment of Attention Deficit Disorder with Hyperactivity.
Lead Product(s): Clonidine
Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Recipient: Las Vegas Medical Research, LLC DBA Vector Clinical Trials
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 01, 2025
Lead Product(s) : Clonidine
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase IV
Recipient : Las Vegas Medical Research, LLC DBA Vector Clinical Trials
Deal Size : Inapplicable
Deal Type : Inapplicable
Study of Clonidine XR Safety & Effectiveness in Children with ADHD & ODD
Details : Clonidine is a Other Small Molecule drug candidate, which is currently being evaluated in Phase IV clinical studies for the treatment of Attention Deficit Disorder with Hyperactivity.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
July 01, 2025
Details:
TRN-228 (cebranopadol) is a first-in-class therapy, with a novel mechanism of action that targets both NOP and MOP receptor, called dual-NMR agonist for the treatment of multiple types of pain.
Lead Product(s): Cebranopadol
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Controlled Substance
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 06, 2025
Lead Product(s) : Cebranopadol
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Tris’ Cebranopadol Shows Positive Phase 3 Results in Acute Pain
Details : TRN-228 (cebranopadol) is a first-in-class therapy, with a novel mechanism of action that targets both NOP and MOP receptor, called dual-NMR agonist for the treatment of multiple types of pain.
Product Name : Undisclosed
Product Type : Controlled Substance
Upfront Cash : Inapplicable
March 06, 2025
Details:
TRN-228 (cebranopadol) is a first-in-class therapy, with a novel mechanism of action that targets both NOP and MOP receptor, called dual-NMR agonist for the treatment of multiple types of pain.
Lead Product(s): Cebranopadol
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Controlled Substance
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 28, 2025
Lead Product(s) : Cebranopadol
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Tris Pharma Reports Low Abusability for Cebranopadol Pain Therapy
Details : TRN-228 (cebranopadol) is a first-in-class therapy, with a novel mechanism of action that targets both NOP and MOP receptor, called dual-NMR agonist for the treatment of multiple types of pain.
Product Name : Undisclosed
Product Type : Controlled Substance
Upfront Cash : Inapplicable
January 28, 2025
Details:
TRN-228 (cebranopadol) is a first-in-class therapy, with a novel mechanism of action that targets both NOP and MOP receptor, called dual-NMR agonist for the treatment of multiple types of pain.
Lead Product(s): Cebranopadol
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Controlled Substance
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 22, 2025
Lead Product(s) : Cebranopadol
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Tris Pharma Presents Positive ALLEVIATE-1 Trial Data for Cebranopadol in Acute Pain
Details : TRN-228 (cebranopadol) is a first-in-class therapy, with a novel mechanism of action that targets both NOP and MOP receptor, called dual-NMR agonist for the treatment of multiple types of pain.
Product Name : Undisclosed
Product Type : Controlled Substance
Upfront Cash : Inapplicable
January 22, 2025
Details:
Quillivant (methylphenidate HCl) is a dopamine/norepinephrine reuptake inhibitor, which is indicated for the treatment of attention deficit hyperactivity disorder in patients aged 6 to 65 years.
Lead Product(s): Methylphenidate Hydrochloride
Therapeutic Area: Psychiatry/Psychology Brand Name: Quillivant XR
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 19, 2024
Lead Product(s) : Methylphenidate Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Tris Pharma Expands Global ADHD Drug Availability with New Approvals
Details : Quillivant (methylphenidate HCl) is a dopamine/norepinephrine reuptake inhibitor, which is indicated for the treatment of attention deficit hyperactivity disorder in patients aged 6 to 65 years.
Product Name : Quillivant XR
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 19, 2024
Details:
TRN-228 (cebranopadol) is a first-in-class therapy, with a novel mechanism of action that targets both NOP and MOP receptor, called dual-NMR agonist for the treatment of multiple types of pain.
Lead Product(s): Cebranopadol
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Controlled Substance
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 21, 2024
Lead Product(s) : Cebranopadol
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Tris Pharma Starts ALLEVIATE-1 and 2 Trials of Cebranopadol for Pain Treatment
Details : TRN-228 (cebranopadol) is a first-in-class therapy, with a novel mechanism of action that targets both NOP and MOP receptor, called dual-NMR agonist for the treatment of multiple types of pain.
Product Name : Undisclosed
Product Type : Controlled Substance
Upfront Cash : Inapplicable
August 21, 2024
Details:
Cebranopadol is a Controlled Substance drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Acute Pain.
Lead Product(s): Cebranopadol
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Controlled Substance
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 09, 2024
Lead Product(s) : Cebranopadol
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
A Study of Cebranopadol for the Treatment of Acute Pain After Abdominoplasty
Details : Cebranopadol is a Controlled Substance drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Acute Pain.
Product Name : Undisclosed
Product Type : Controlled Substance
Upfront Cash : Inapplicable
August 09, 2024
Details:
Cebranopadol is a Controlled Substance drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Substance-Related Disorders.
Lead Product(s): Cebranopadol
Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Controlled Substance
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 11, 2024
Lead Product(s) : Cebranopadol
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
A Study to Assess the Abuse Potential of Intranasal Cebranopadol
Details : Cebranopadol is a Controlled Substance drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Substance-Related Disorders.
Product Name : Undisclosed
Product Type : Controlled Substance
Upfront Cash : Inapplicable
June 11, 2024
Details:
FDA has approved ONYDA™ XR (clonidine hydrochloride), a once-a-day extended-release oral suspension for the treatment of ADHD in pediatric patients six years and older.
Lead Product(s): Clonidine
Therapeutic Area: Psychiatry/Psychology Brand Name: Onyda
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 29, 2024
Lead Product(s) : Clonidine
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Tris Pharma Gets FDA Approval for ONYDA XR, First Liquid ADHD Medication
Details : FDA has approved ONYDA™ XR (clonidine hydrochloride), a once-a-day extended-release oral suspension for the treatment of ADHD in pediatric patients six years and older.
Product Name : Onyda
Product Type : Miscellaneous
Upfront Cash : Inapplicable
May 29, 2024
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
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Tris Pharma Inc is a supplier offers 6 products (APIs, Excipients or Intermediates).
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