Synopsis
Synopsis
0
CEP/COS
0
JDMF
0
EU WC
0
KDMF
0
VMF
0
EDQM
0
USP
0
JP
0
Others
0
Europe
0
Australia
0
South Africa
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS
Regulatory FDF Prices
NA
0
FDF
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers


1. Glyceroltriheptanoate
2. Glyceryl Triheptanoate
1. 620-67-7
2. Propane-1,2,3-triyl Triheptanoate
3. Trienanthoin
4. Trioenanthoin
5. Glyceryl Triheptanoate
6. Glycerol Triheptanoate
7. Triheptanoic Glyceride
8. Heptanoin, Tri-
9. Ux007
10. Dermofeel Tc 7
11. Dojolvi
12. Propane-1,2,3-triyl Trisheptanoate
13. 2,3-di(heptanoyloxy)propyl Heptanoate
14. Dub Thg
15. Heptanoic Acid, 1,2,3-propanetriyl Ester
16. Dermofeel Tc-7
17. Ux-007
18. Radiamuls 2375
19. Lanol 37 T
20. Triheptanoin [usan]
21. 2p6o7cfw5k
22. 3-02-00-00769 (beilstein Handbook Reference)
23. Heptanoic Acid, 1,1',1''-(1,2,3-propanetriyl) Ester
24. Triheptanoin (usan)
25. Triheptylin
26. 1,2,3-propanetriyl Triheptanoate
27. Glyceroltriheptanoate
28. Brn 1807724
29. Lanol 37t
30. Einecs 210-647-2
31. Unii-2p6o7cfw5k
32. Trienantin
33. Dojolvi (tn)
34. Glycerol Trienanthate
35. Glyceryl Trienanthate
36. Triheptanoin [mi]
37. Triheptanoin [inn]
38. Ec 210-647-2
39. Triheptanoin [inci]
40. Schembl525618
41. Triheptanoin [who-dd]
42. Glycerol Trienanthate, >=94%
43. Chembl4297585
44. Gtpl11431
45. Dtxsid40862306
46. Propane-1,2,3-triyltriheptanoate
47. Triheptanoin [orange Book]
48. Zinc4521897
49. Ind106011
50. Mfcd00042910
51. Ux 007
52. 1r,2s-(-)-norephedrinehydrochloride
53. Cs-w013852
54. Db11677
55. Hy-w013136
56. Ind 106011
57. Ind-106011
58. Ind106011; Ux007
59. Ls-15081
60. Ft-0757070
61. D11465
62. A868568
63. Q414576
64. W-109093
| Molecular Weight | 428.6 g/mol |
|---|---|
| Molecular Formula | C24H44O6 |
| XLogP3 | 7.3 |
| Hydrogen Bond Donor Count | 0 |
| Hydrogen Bond Acceptor Count | 6 |
| Rotatable Bond Count | 23 |
| Exact Mass | 428.31378912 g/mol |
| Monoisotopic Mass | 428.31378912 g/mol |
| Topological Polar Surface Area | 78.9 Ų |
| Heavy Atom Count | 30 |
| Formal Charge | 0 |
| Complexity | 421 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
Triheptanoin is a medium chain triglyceride indicated to provide calories and fatty acids to treat long chain fatty acid oxidation disorders (lc-FAODs).
FDA Label
Triheptanoin is a source of medium chain fatty acids for patients with lc-FAODs. It has a moderate duration of action and a wide therapeutic window. Patients should be counselled regarding the risk of feeding tube dysfunction and intestinal malabsorption due to pancreatic insufficiency.
A - Alimentary tract and metabolism
A16 - Other alimentary tract and metabolism products
A16A - Other alimentary tract and metabolism products
A16AX - Various alimentary tract and metabolism products
A16AX17 - Triheptanoin
Absorption
A single 0.3 g/kg dose of triheptanoin reaches a Cmax of 178.9 mol/L, with a Tmax 0.5 h, and an AUC of 336.5 mol\*h/L. A single 0.4 g/kg dose of triheptanoin reaches a Cmax of 259.1 mol/L, with a Tmax 0.8 h, and an AUC of 569.1 mol\*h/L.
Route of Elimination
Triheptanoin is minimally eliminated in the urine.
Clearance
A single dose of 0.3 g/kg results in a mean apparent clearance of 6.05 L/h/kg for heptanoate. A single dose of 0.4 g/kg results in a mean apparent clearance of 4.31 L/h/kg for heptanoate.
Triheptanoin is hydrolysed to heptanoate, which can be further metabolized to -hydroxypentanoate or -hydroxybutyrate.
Due to multiple peak concentrations of the heptanoate metabolite, the half life of triheptanoin could not be determined.
Triheptanoin is a source of heptanoate fatty acids, which can be metabolized without the enzymes of long chain fatty acid oxidation. In clinical trials, patients with lc-FAODs treated with triheptanoin experienced improvements in hypoglycemia, cardiomyopathy, and rhabdomyolysis.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
NDC Package Code : 15894-0041
Start Marketing Date : 2024-01-03
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2025-09-02
Pay. Date : 2025-07-09
DMF Number : 42237
Submission : 2025-07-06
Status : Active
Type : II

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-04-16
Pay. Date : 2024-03-22
DMF Number : 39441
Submission : 2024-03-26
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39145
Submission : 2024-02-07
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26895
Submission : 2013-03-01
Status : Active
Type : II

GDUFA
DMF Review : Reviewed
Rev. Date : 2024-04-16
Pay. Date : 2024-03-15
DMF Number : 39415
Submission : 2024-03-29
Status : Active
Type : II

GDUFA
DMF Review : Reviewed
Rev. Date : 2024-03-21
Pay. Date : 2024-01-25
DMF Number : 39430
Submission : 2024-02-08
Status : Active
Type : II
NDC Package Code : 59651-938
Start Marketing Date : 2024-01-23
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
GDUFA
DMF Review : Complete
Rev. Date : 2024-03-21
Pay. Date : 2024-01-25
DMF Number : 39430
Submission : 2024-02-08
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2024-04-16
Pay. Date : 2024-03-22
DMF Number : 39441
Submission : 2024-03-26
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2024-04-16
Pay. Date : 2024-03-15
DMF Number : 39415
Submission : 2024-03-29
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39145
Submission : 2024-02-07
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26895
Submission : 2013-03-01
Status : Active
Type : II

USDMF
GDUFA
DMF Review : Complete
Rev. Date : 2025-09-02
Pay. Date : 2025-07-09
DMF Number : 42237
Submission : 2025-07-06
Status : Active
Type : II

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
NDC Package Code : 15894-0041
Start Marketing Date : 2024-01-03
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 59651-938
Start Marketing Date : 2024-01-23
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long legacy of advancing health through innovation. Today, we offer one of the industry’s most comprehensive API portfolios ...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Details:
Triheptanoin is a Other Small Molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Medium chain acyl CoA dehydrogenase Deficiency.
Lead Product(s): Triheptanoin,Inapplicable
Therapeutic Area: Genetic Disease Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Ultragenyx Pharmaceutical
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 31, 2025

Lead Product(s) : Triheptanoin,Inapplicable
Therapeutic Area : Genetic Disease
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Ultragenyx Pharmaceutical
Deal Size : Inapplicable
Deal Type : Inapplicable
Study of Triheptanoin Use in Patients with Medium-Chain Acyl-CoA Dehydrogenase Deficiency
Details : Triheptanoin is a Other Small Molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Medium chain acyl CoA dehydrogenase Deficiency.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
July 31, 2025

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Details:
Triheptanoin is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Pyruvate Dehydrogenase Complex Deficiency Disease.
Lead Product(s): Triheptanoin,Inapplicable
Therapeutic Area: Rare Diseases and Disorders Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Jirair Krikor Bedoyan
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 01, 2024

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Lead Product(s) : Triheptanoin,Inapplicable
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Jirair Krikor Bedoyan
Deal Size : Inapplicable
Deal Type : Inapplicable
Triheptanoin for Children with Primary-Specific Pyruvate Dehydrogenase Complex (PDC) Deficiency
Details : Triheptanoin is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Pyruvate Dehydrogenase Complex Deficiency Disease.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 01, 2024

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Details:
Triheptanoin is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Medium chain acyl CoA dehydrogenase Deficiency.
Lead Product(s): Triheptanoin,Inapplicable
Therapeutic Area: Genetic Disease Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Jerry Vockley
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 05, 2023

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Lead Product(s) : Triheptanoin,Inapplicable
Therapeutic Area : Genetic Disease
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Jerry Vockley
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Triheptanoin is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Medium chain acyl CoA dehydrogenase Deficiency.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 05, 2023

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Details:
Triheptanoin is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Long-chain Fatty Acid Oxidation Disorders.
Lead Product(s): Triheptanoin,Inapplicable
Therapeutic Area: Genetic Disease Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 06, 2023

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Lead Product(s) : Triheptanoin,Inapplicable
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Triheptanoin is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Long-chain Fatty Acid Oxidation Disorders.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
July 06, 2023

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Details:
Orsini Pharmaceutical Services has been selected by Ultragenyx Pharmaceutical as a limited distribution specialty pharmacy partner for Dojolvi (triheptanoin). Dojolvi™ is indicated as a source of calories and fatty acids for the treatment of molecularly confirmed LC-FAOD.
Lead Product(s): Triheptanoin,Inapplicable
Therapeutic Area: Genetic Disease Brand Name: Dojolvi
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Ultragenyx Pharmaceutical
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership July 10, 2020

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Lead Product(s) : Triheptanoin,Inapplicable
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Ultragenyx Pharmaceutical
Deal Size : Undisclosed
Deal Type : Partnership
Orsini Pharmaceutical Services Expands Partnership With Ultragenyx To Provide Dojolvi™ (trihepta...
Details : Orsini Pharmaceutical Services has been selected by Ultragenyx Pharmaceutical as a limited distribution specialty pharmacy partner for Dojolvi (triheptanoin). Dojolvi™ is indicated as a source of calories and fatty acids for the treatment of molecularl...
Product Name : Dojolvi
Product Type : Miscellaneous
Upfront Cash : Undisclosed
July 10, 2020

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Details:
Triheptanoin is a Other Small Molecule drug candidate, which is currently being evaluated in clinical studies for the treatment of undefined medical condition.
Lead Product(s): Triheptanoin,Inapplicable
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 12, 2018

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Lead Product(s) : Triheptanoin,Inapplicable
Therapeutic Area : Undisclosed
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Expanded Access to Triheptanoin
Details : Triheptanoin is a Other Small Molecule drug candidate, which is currently being evaluated in clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 12, 2018

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Details:
Triheptanoin is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Glycogen Storage Disease Type I.
Lead Product(s): Triheptanoin,Inapplicable
Therapeutic Area: Genetic Disease Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Areeg El-Gharbawy
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 11, 2018

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Lead Product(s) : Triheptanoin,Inapplicable
Therapeutic Area : Genetic Disease
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Areeg El-Gharbawy
Deal Size : Inapplicable
Deal Type : Inapplicable
Anaplerotic Therapy Using Triheptanoin for Patients With Glycogen Storage Disease Type I
Details : Triheptanoin is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Glycogen Storage Disease Type I.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 11, 2018

Details:
Triheptanoin is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Glycogen Storage Disease Type VII.
Lead Product(s): Triheptanoin,Inapplicable
Therapeutic Area: Genetic Disease Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Ultragenyx Pharmaceutical
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 22, 2018

Lead Product(s) : Triheptanoin,Inapplicable
Therapeutic Area : Genetic Disease
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Ultragenyx Pharmaceutical
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Triheptanoin is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Glycogen Storage Disease Type VII.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 22, 2018

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Details:
Triheptanoin is a Other Small Molecule drug candidate, which is currently being evaluated in phase I/ phase II clinical studies for the treatment of Amyotrophic Lateral Sclerosis.
Lead Product(s): Triheptanoin,Inapplicable
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase I/ Phase IIProduct Type: Miscellaneous
Sponsor: Richard Bedlack, M.D., Ph.D.
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 24, 2018

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Lead Product(s) : Triheptanoin,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Richard Bedlack, M.D., Ph.D.
Deal Size : Inapplicable
Deal Type : Inapplicable
A Pilot Trial of Triheptanoin for People With Amyotrophic Lateral Sclerosis (PALS)
Details : Triheptanoin is a Other Small Molecule drug candidate, which is currently being evaluated in phase I/ phase II clinical studies for the treatment of Amyotrophic Lateral Sclerosis.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 24, 2018

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Details:
Triheptanoin is a Other Small Molecule drug candidate, which is currently being evaluated in clinical studies for the treatment of Glut1 Deficiency Syndrome.
Lead Product(s): Triheptanoin,Inapplicable
Therapeutic Area: Genetic Disease Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Miscellaneous
Sponsor: Jerry Vockley
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 21, 2016

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Lead Product(s) : Triheptanoin,Inapplicable
Therapeutic Area : Genetic Disease
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Jerry Vockley
Deal Size : Inapplicable
Deal Type : Inapplicable
Treatment With UX007 for a Single Patient With GLUT1 Deficiency Syndrome
Details : Triheptanoin is a Other Small Molecule drug candidate, which is currently being evaluated in clinical studies for the treatment of Glut1 Deficiency Syndrome.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 21, 2016

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Global Sales Information
Main Therapeutic Indication : Rare Disorders
Currency : USD
2019 Revenue in Millions : 3
2018 Revenue in Millions : 1
Growth (%) : 163

Main Therapeutic Indication : Rare Disorders
Currency : USD
2020 Revenue in Millions : 13
2019 Revenue in Millions : 3
Growth (%) : 295

Main Therapeutic Indication : Rare Disorders
Currency : USD
2021 Revenue in Millions : 40
2020 Revenue in Millions : 13
Growth (%) : 204

Main Therapeutic Indication : Rare Diseases
Currency : USD
2022 Revenue in Millions : 56
2021 Revenue in Millions : 40
Growth (%) : 41

Main Therapeutic Indication : Rare Diseases
Currency : USD
2023 Revenue in Millions : 71
2022 Revenue in Millions : 56
Growth (%) : 27

Main Therapeutic Indication : Rare Diseases and Disorders
Currency : USD
2024 Revenue in Millions : 88
2023 Revenue in Millions : 71
Growth (%) : 25

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
Patents & EXCLUSIVITIES
ABOUT THIS PAGE
62
PharmaCompass offers a list of Triheptanoin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Triheptanoin manufacturer or Triheptanoin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Triheptanoin manufacturer or Triheptanoin supplier.
A TRIHEPTANOIN ULTRAPURE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of TRIHEPTANOIN ULTRAPURE, including repackagers and relabelers. The FDA regulates TRIHEPTANOIN ULTRAPURE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. TRIHEPTANOIN ULTRAPURE API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of TRIHEPTANOIN ULTRAPURE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A TRIHEPTANOIN ULTRAPURE supplier is an individual or a company that provides TRIHEPTANOIN ULTRAPURE active pharmaceutical ingredient (API) or TRIHEPTANOIN ULTRAPURE finished formulations upon request. The TRIHEPTANOIN ULTRAPURE suppliers may include TRIHEPTANOIN ULTRAPURE API manufacturers, exporters, distributors and traders.
click here to find a list of TRIHEPTANOIN ULTRAPURE suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A TRIHEPTANOIN ULTRAPURE DMF (Drug Master File) is a document detailing the whole manufacturing process of TRIHEPTANOIN ULTRAPURE active pharmaceutical ingredient (API) in detail. Different forms of TRIHEPTANOIN ULTRAPURE DMFs exist exist since differing nations have different regulations, such as TRIHEPTANOIN ULTRAPURE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A TRIHEPTANOIN ULTRAPURE DMF submitted to regulatory agencies in the US is known as a USDMF. TRIHEPTANOIN ULTRAPURE USDMF includes data on TRIHEPTANOIN ULTRAPURE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The TRIHEPTANOIN ULTRAPURE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of TRIHEPTANOIN ULTRAPURE suppliers with USDMF on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing TRIHEPTANOIN ULTRAPURE as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for TRIHEPTANOIN ULTRAPURE API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture TRIHEPTANOIN ULTRAPURE as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain TRIHEPTANOIN ULTRAPURE and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a TRIHEPTANOIN ULTRAPURE NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of TRIHEPTANOIN ULTRAPURE suppliers with NDC on PharmaCompass.
TRIHEPTANOIN ULTRAPURE Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of TRIHEPTANOIN ULTRAPURE GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right TRIHEPTANOIN ULTRAPURE GMP manufacturer or TRIHEPTANOIN ULTRAPURE GMP API supplier for your needs.
A TRIHEPTANOIN ULTRAPURE CoA (Certificate of Analysis) is a formal document that attests to TRIHEPTANOIN ULTRAPURE's compliance with TRIHEPTANOIN ULTRAPURE specifications and serves as a tool for batch-level quality control.
TRIHEPTANOIN ULTRAPURE CoA mostly includes findings from lab analyses of a specific batch. For each TRIHEPTANOIN ULTRAPURE CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
TRIHEPTANOIN ULTRAPURE may be tested according to a variety of international standards, such as European Pharmacopoeia (TRIHEPTANOIN ULTRAPURE EP), TRIHEPTANOIN ULTRAPURE JP (Japanese Pharmacopeia) and the US Pharmacopoeia (TRIHEPTANOIN ULTRAPURE USP).