Find Stiripentol manufacturers, exporters & distributors on PharmaCompass

PharmaCompass

Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

0

CEP/COS

CEP/COS Certifications

0

JDMF

JDMFs Filed

0

KDMF

KDMF

0

VMF

NDC API

0INTERMEDIATES

REF. STANDARDS OR IMPURITIES

0

EDQM

0

USP

0

JP

0

Others

FINISHED DOSAGE FORMULATIONS

0

South Africa

South Africa

0

Listed Dossiers

Listed Dossiers

FDF Dossiers

DRUG PRODUCT COMPOSITIONS

0RELATED EXCIPIENT COMPANIES

0EXCIPIENTS BY APPLICATIONS

PATENTS & EXCLUSIVITIES

0

US Patents

0

Health Canada Patents

API REF. PRICE (USD/KG)

GLOBAL SALES INFORMATION

Annual Reports

NA

API/FDF Prices: Book a Demo to
explore the features and consider
upgrading later

MARKET PLACE

DIGITAL CONTENT

0

Data Compilation #PharmaFlow

0

Stock Recap #PipelineProspector

0

Weekly News Recap #Phispers

Chemistry

Click the arrow to open the dropdown
read-moreClick the button for full data set
Also known as: 49763-96-4, Diacomit, Bcx 2600, 1-(1,3-benzodioxol-5-yl)-4,4-dimethyl-1-penten-3-ol, 137767-55-6, Bcx-2600
Molecular Formula
C14H18O3
Molecular Weight
234.29  g/mol
InChI Key
IBLNKMRFIPWSOY-FNORWQNLSA-N
FDA UNII
R02XOT8V8I

Stiripentol
Stiripentol is an anticonvulsant drug used in the treatment of epilepsy as an adjunct therapy along with [DB00349] and [DB00313]. This drug is currently approved in the USA, Canada, and European countries as oral tablets marketed as Diacomit. FDA approval of this drug was granted on August 20, 2018,. Unrelated to other anticonvulsants, stiripentol belongs to the group of aromatic allylic alcohols and may potentiate the effect of other antiepileptic drugs (AEDs) due to pharmacokinetic interactions. It elevates the levels of gamma-aminobutyric acid (GABA), a major inhibitory neurotransmitter that regulates electrical activity in the central nervous system.
1 2D Structure

Stiripentol

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(E)-1-(1,3-benzodioxol-5-yl)-4,4-dimethylpent-1-en-3-ol
2.1.2 InChI
InChI=1S/C14H18O3/c1-14(2,3)13(15)7-5-10-4-6-11-12(8-10)17-9-16-11/h4-8,13,15H,9H2,1-3H3/b7-5+
2.1.3 InChI Key
IBLNKMRFIPWSOY-FNORWQNLSA-N
2.1.4 Canonical SMILES
CC(C)(C)C(C=CC1=CC2=C(C=C1)OCO2)O
2.1.5 Isomeric SMILES
CC(C)(C)C(/C=C/C1=CC2=C(C=C1)OCO2)O
2.2 Other Identifiers
2.2.1 UNII
R02XOT8V8I
2.3 Synonyms
2.3.1 MeSH Synonyms

1. D-306

2. Diacomit

2.3.2 Depositor-Supplied Synonyms

1. 49763-96-4

2. Diacomit

3. Bcx 2600

4. 1-(1,3-benzodioxol-5-yl)-4,4-dimethyl-1-penten-3-ol

5. 137767-55-6

6. Bcx-2600

7. 1-(benzo[d][1,3]dioxol-5-yl)-4,4-dimethylpent-1-en-3-ol

8. 4,4-dimethyl-1-((3,4-methylenedioxy)phenyl)-1-penten-3-ol

9. (1e)-1-(2h-1,3-benzodioxol-5-yl)-4,4-dimethylpent-1-en-3-ol

10. Ncgc00185769-01

11. Estiripentol

12. 1-penten-3-ol, 4,4-dimethyl-1-(3,4-methylenedioxyphenyl)-

13. (e)-1-(benzo[d][1,3]dioxol-5-yl)-4,4-dimethylpent-1-en-3-ol

14. 1-penten-3-ol, 1-(1,3-benzodioxol-5-yl)-4,4-dimethyl-

15. Stiripentolum

16. Stiripentol [mi]

17. Stiripentol [inn]

18. Stiripentol [jan]

19. Stiripentol [usan:inn]

20. Stiripentol [usan]

21. Stiripentolum [inn-latin]

22. Estiripentol [inn-spanish]

23. Stiripentol [mart.]

24. 4,4-dimethyl-1-(3,4-methylenedioxyphenyl)-1-penten-3-ol

25. Smr000449279

26. Stiripentol [who-dd]

27. Stiripentol [ema Epar]

28. R02xot8v8i

29. Einecs 256-480-9

30. Mfcd00869310

31. Brn 1313047

32. (e)-1-(1,3-benzodioxol-5-yl)-4,4-dimethylpent-1-en-3-ol

33. Diacomit (tn)

34. Me-2080

35. Cpd000449279

36. Dsstox_cid_28994

37. Dsstox_rid_83259

38. Dsstox_gsid_49068

39. 5-19-02-00640 (beilstein Handbook Reference)

40. Mls000758313

41. Mls001424144

42. Schembl216436

43. Stiripentol (jan/usan/inn)

44. Gtpl5469

45. Schembl2533815

46. Chembl1983350

47. Chebi:94435

48. Stiripentol, >=98% (hplc)

49. Dtxsid80860609

50. Stiripentol [orange Book]

51. Hms2052k07

52. Hms2232p06

53. Hms3886m17

54. Bcp10434

55. Tox21_113622

56. Bdbm50504273

57. S5266

58. Akos025149123

59. Akos027255159

60. Ccg-101092

61. Ccg-266819

62. Cs-7801

63. Db09118

64. Nc00342

65. Ncgc00185769-02

66. Bs-16863

67. Cas-49763-96-4

68. Hy-103392

69. D05928

70. W10731

71. Bcx2600; Bcx-2600; Bcx 2600

72. 763s964

73. Q412182

74. (1e)-1-(1,3-benzodioxol-5-yl)-4,4-dimethyl-1-penten-3-ol

75. (e)-1-(3,4-methylenedioxyphenyl)-4,4-dimethyl-1-penten-3-ol

76. 131206-47-8

2.4 Create Date
2005-09-13
3 Chemical and Physical Properties
Molecular Weight 234.29 g/mol
Molecular Formula C14H18O3
XLogP33.6
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count3
Rotatable Bond Count3
Exact Mass234.125594432 g/mol
Monoisotopic Mass234.125594432 g/mol
Topological Polar Surface Area38.7 Ų
Heavy Atom Count17
Formal Charge0
Complexity280
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count1
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

Indicated for use in conjunction with clobazam and valproate as adjunctive therapy of refractory generalized tonic-clonic seizures in patients with severe myoclonic epilepsy in infancy (SMEI, Dravets syndrome) whose seizures are not adequately controlled with clobazam and valproate.


Diacomit is indicated for use in conjunction with clobazam and valproate as adjunctive therapy of refractory generalized tonic-clonic seizures in patients with severe myoclonic epilepsy in infancy (SMEI, Dravet's syndrome) whose seizures are not adequately controlled with clobazam and valproate.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Stiripentol is an orphan drug that effectively reduces seizure frequency in infantile epilepsy as an adjunct therapy and also exhibits a therapeutic advantage in improving the efficacy of other antiepileptic drugs. It potentiates GABA transmission by elevating the levels of the inhibitory neurotransmitters in the brain. Stiripentol is a positive allosteric modulator of GABA-A receptors in the brain that enhances the opening duration of the channel by binding to a site different than the benzodiazepine binding site. Reduced synaptosomal uptake of GABA and/or inhibition of GABA transaminase may also explain the role of stiripentol in reducing the events of seizure. The anticonvulsant activity of stiripentol is age-dependent, with increased efficacy in younger patients.


5.2 MeSH Pharmacological Classification

Anticonvulsants

Drugs used to prevent SEIZURES or reduce their severity. (See all compounds classified as Anticonvulsants.)


5.3 ATC Code

N03AX17


N - Nervous system

N03 - Antiepileptics

N03A - Antiepileptics

N03AX - Other antiepileptics

N03AX17 - Stiripentol


5.4 Absorption, Distribution and Excretion

Absorption

Absorption of stiripentol is quick with the peak plasma concentration reached within 1.5 hours following oral administration. The systemic exposure increases in a dose-proportional relationship. It is rapidly taken up into the brain and enters the cerebellum and medulla. It displays low bioavailability due to water insolubility and metabolism.


Route of Elimination

Renal elimination is mainly responsible for excretion of stiripentol. About 73% of total administered dose is found in urine as metabolites, while further 13-24% of the total dose is recovered in faeces as unchanged substance.


Volume of Distribution

The average volume of distribution is 1.03 L/kg but does not display a dose-dependent relationship. It is expected to be distributed into the extravascular space and with a high degree of tissue binding.


Clearance

Plasma clearance decreases markedly at high doses; it falls from approximately 40 L/kg/day at the dose of 600 mg/day to about 8 L/kg/day at the dose of 2,400 mg. Decreased clearance is probably explained by inhibition of the cytochrome P450 isoenzymes that catalyzes stiripentol metabolism.


5.5 Metabolism/Metabolites

There are 13 metabolites from extensive metabolism stiripentol that are found in urine. The predominant metabolic pathways involve demethylenation and glucuronidation. Other metabolic pathways are oxidative cleavage of the methylenedioxy ring system, O-methylation of catechol metabolites, hydroxylation of the t-butyl group and conversion of the allylic alcohol side-chain to the isomeric 3-pentanone structure. Based on in vitro studies, phase I metabolism of stiripentol involves enzymatic activity of CYP1A2, CYP2C19 and CYP3A4.


5.6 Biological Half-Life

Elimination half life is approximately ranges from 4.5 to 13 hours, in a dose-dependent manner.


5.7 Mechanism of Action

Stiripentol enhances GABAergic inhibition and prolongs the open duration of GABA-A receptor chloride channels by a barbiturate-like mechanism. It binds to GABA-A receptors containing any of the , , , or -subunits but displays strongest potency when bound to receptors containing 3 or subunits. Stiripentol is an inhibitor of lactate dehydrogenase (LDH), which plays a physiological role in energy metabolism of neurons and regulation of neuronal excitation. It binds to the site separate from lactate and pyruvate binding sites of the enzyme and inhibits both pyruvate-to-lactate conversion and lactate-to-pyruvate conversion. LDH inhibitors including stiripentol as antiepileptic treatments mimic ketogenic diet, where the energy source in the brain is switched from glucose to mainly ketone bodies. The ketone bodies directly regulate neuronal excitation and seizures via ATP-sensitive potassium channels and vesicular glutamate transporters. As a potent inhibitor of hepatic cytochrome P450 enzymes, mainly CYP3A4 and CYP2C19, stiripentol co-administration with other antiepileptic drugs elevates the free unchanged active drugs (such as carbamazepine, sodium valproate, phenytoin, phenobarbital and many benzodiazepines) in the circulation to mediate their therapeutic actions.


API SUPPLIERS

read-more
read-more

01

Nuray Chemicals Private Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.

Flag India
Digital Content Digital Content
USDMF arrow-down Click Us! arrow-down
CEP/COS JDMF EU-WCarrow-down NDC arrow-down KDMF VMF Others AUDIT
Nuray Chemicals

02

Metrochem API Private Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

Flag India
Digital Content Digital Content
USDMF arrow-down CEP/COS JDMF EU-WC NDC arrow-down KDMF VMF Others AUDIT
Metrochem

03

HRV Global Life Sciences

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

Flag India
Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF AU arrow-down AUDIT
HRV Global Life Sciences

04

Torrent Pharmaceuticals Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Hospitalar
Not Confirmed
arrow

Torrent Pharmaceuticals Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

arrow
Hospitalar
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
blank

05

ALP Pharm

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Hospitalar
Not Confirmed
arrow

ALP Pharm

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

arrow
Hospitalar
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
blank

06

MSN Laboratories

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Hospitalar
Not Confirmed
arrow

MSN Laboratories

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

arrow
Hospitalar
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WC NDC arrow-down KDMF VMF Others AUDIT
blank

07

SMS Pharmaceuticals

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Hospitalar
Not Confirmed
arrow

08

Cohesion Biotec

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Hospitalar
Not Confirmed
arrow
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

API Reference Price

read-more
read-more
[{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734460200,"product":"STIRIPENTOL IHS","address":"FLAT NO.302, BHANU ENCLAVE","city":"HYDERABAD.AP","supplier":"METROCHEM API PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"SHEREMETYEVO","customer":"LIFE SCIENCES OCPC LIMITED,","customerCountry":"RUSSIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"2129.4","totalValueFC":"4205.3","currency":"USD","unitRateINR":178659.60000000001,"date":"18-Dec-2024","totalValueINR":"357319.2","totalValueInUsd":"4205.3","indian_port":"Hyderabad Air","hs_no":"29329990","bill_no":"6549142","productDescription":"API","marketType":"","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"FLAT NO.302, BHANU ENCLAVE, HYDERABAD.AP","customerAddress":""}]
18-Dec-2024
18-Dec-2024
KGS
overview
Loading...

Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API/FDF Prices: Book a Demo to explore the features and consider upgrading later

API Imports and Exports

Importing Country Total Quantity
(KGS)
Average Price
(USD/KGS)
Number of Transactions

Upgrade, download data, analyse, strategize, subscribe with us contact

Drugs in Development

read-more
read-more

Details:

Diacomit (stiripentol) a GABA-A receptor inhibitor oral suspension, a new formulation is being investigated to aid in the treatment of dravet syndrome in young children.


Lead Product(s): Stiripentol

Therapeutic Area: Neurology Brand Name: Diacomit

Study Phase: Phase IProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 14, 2024

blank

01

Biocodex

France
arrow
STLE Annual Meeting
Not Confirmed

Biocodex

France
arrow
STLE Annual Meeting
Not Confirmed

Details : Diacomit (stiripentol) a GABA-A receptor inhibitor oral suspension, a new formulation is being investigated to aid in the treatment of dravet syndrome in young children.

Product Name : Diacomit

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

November 14, 2024

blank

Details:

DIACOMIT (stiripentol) is an effective treatment for seizures that are often resistant to other antiepileptic drugs. In two clinical studies, DIACOMIT reduced generalized clonic or tonic-clonic seizures by a median of 84% compared with 5.8% on placebo after two months.


Lead Product(s): Stiripentol

Therapeutic Area: Neurology Brand Name: Diacomit

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 21, 2022

blank

02

Biocodex

France
arrow
STLE Annual Meeting
Not Confirmed

Biocodex

France
arrow
STLE Annual Meeting
Not Confirmed

Details : DIACOMIT (stiripentol) is an effective treatment for seizures that are often resistant to other antiepileptic drugs. In two clinical studies, DIACOMIT reduced generalized clonic or tonic-clonic seizures by a median of 84% compared with 5.8% on placebo af...

Product Name : Diacomit

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

September 21, 2022

blank

Details:

DIACOMIT (stiripentol), is a molecular entity approved by the FDA for the adjunctive treatment of seizures associated with Dravet syndrome in 2 years of age and older taking clobazam. An orally administered, DIACOMIT is given as either a capsule or powder for suspension.


Lead Product(s): Stiripentol

Therapeutic Area: Neurology Brand Name: Diacomit

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: PANTHERx Rare Pharmacy

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Partnership June 27, 2022

blank

03

Biocodex

France
arrow
STLE Annual Meeting
Not Confirmed

Biocodex

France
arrow
STLE Annual Meeting
Not Confirmed

Details : DIACOMIT (stiripentol), is a molecular entity approved by the FDA for the adjunctive treatment of seizures associated with Dravet syndrome in 2 years of age and older taking clobazam. An orally administered, DIACOMIT is given as either a capsule or powde...

Product Name : Diacomit

Product Type : Other Small Molecule

Upfront Cash : Undisclosed

June 27, 2022

blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Digital Content read-more

Create Content with PharmaCompass, ask us

NEWS #PharmaBuzz

read-more
read-more

Global Sales Information

Do you need Business Intel? Ask us

US Medicaid Prescriptions

read-more
read-more

01

arrow
STLE Annual Meeting
Not Confirmed
arrow
STLE Annual Meeting
Not Confirmed

Company :

Stiripentol

Drug Cost (USD) : 854,407

Year : 2022

Prescribers : 21

Prescriptions : 205

blank

02

arrow
STLE Annual Meeting
Not Confirmed
arrow
STLE Annual Meeting
Not Confirmed

Company :

Stiripentol

Drug Cost (USD) : 468,575

Year : 2021

Prescribers : 12

Prescriptions : 112

blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Market Place

Do you need sourcing support? Ask us

Patents & EXCLUSIVITIES

Check the patents & exclusivity for this product

US Exclusivities

read-more
read-more

01

arrow
STLE Annual Meeting
Not Confirmed

BIOCODEX SA

France
arrow
STLE Annual Meeting
Not Confirmed

STIRIPENTOL

Exclusivity Code : M-281

Exclusivity Expiration Date : 2025-07-14

Application Number : 206709

Product Number : 1

Exclusivity Details :

blank

02

arrow
STLE Annual Meeting
Not Confirmed

BIOCODEX SA

France
arrow
STLE Annual Meeting
Not Confirmed

STIRIPENTOL

Exclusivity Code : ODE-198

Exclusivity Expiration Date : 2025-08-20

Application Number : 206709

Product Number : 1

Exclusivity Details :

blank

03

arrow
STLE Annual Meeting
Not Confirmed

BIOCODEX SA

France
arrow
STLE Annual Meeting
Not Confirmed

STIRIPENTOL

Exclusivity Code : ODE-403

Exclusivity Expiration Date : 2029-07-14

Application Number : 206709

Product Number : 1

Exclusivity Details :

blank

04

arrow
STLE Annual Meeting
Not Confirmed

BIOCODEX SA

France
arrow
STLE Annual Meeting
Not Confirmed

STIRIPENTOL

Exclusivity Code : M-281

Exclusivity Expiration Date : 2025-07-14

Application Number : 206709

Product Number : 2

Exclusivity Details :

blank

05

arrow
STLE Annual Meeting
Not Confirmed

BIOCODEX SA

France
arrow
STLE Annual Meeting
Not Confirmed

STIRIPENTOL

Exclusivity Code : ODE-198

Exclusivity Expiration Date : 2025-08-20

Application Number : 206709

Product Number : 2

Exclusivity Details :

blank

06

arrow
STLE Annual Meeting
Not Confirmed

BIOCODEX SA

France
arrow
STLE Annual Meeting
Not Confirmed

STIRIPENTOL

Exclusivity Code : ODE-403

Exclusivity Expiration Date : 2029-07-14

Application Number : 206709

Product Number : 2

Exclusivity Details :

blank

07

arrow
STLE Annual Meeting
Not Confirmed

BIOCODEX SA

France
arrow
STLE Annual Meeting
Not Confirmed

STIRIPENTOL

Exclusivity Code : NPP

Exclusivity Expiration Date : 2025-07-14

Application Number : 207223

Product Number : 1

Exclusivity Details :

blank

08

arrow
STLE Annual Meeting
Not Confirmed

BIOCODEX SA

France
arrow
STLE Annual Meeting
Not Confirmed

STIRIPENTOL

Exclusivity Code : ODE-198

Exclusivity Expiration Date : 2025-08-20

Application Number : 207223

Product Number : 1

Exclusivity Details :

blank

09

arrow
STLE Annual Meeting
Not Confirmed

BIOCODEX SA

France
arrow
STLE Annual Meeting
Not Confirmed

STIRIPENTOL

Exclusivity Code : ODE-403

Exclusivity Expiration Date : 2029-07-14

Application Number : 207223

Product Number : 1

Exclusivity Details :

blank

10

arrow
STLE Annual Meeting
Not Confirmed

BIOCODEX SA

France
arrow
STLE Annual Meeting
Not Confirmed

STIRIPENTOL

Exclusivity Code : NPP

Exclusivity Expiration Date : 2025-07-14

Application Number : 207223

Product Number : 2

Exclusivity Details :

blank
click full view
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

ABOUT THIS PAGE

Looking for 131206-47-8 / Stiripentol API manufacturers, exporters & distributors?

Stiripentol manufacturers, exporters & distributors 1

72

PharmaCompass offers a list of Stiripentol API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Stiripentol manufacturer or Stiripentol supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Stiripentol manufacturer or Stiripentol supplier.

PharmaCompass also assists you with knowing the Stiripentol API Price utilized in the formulation of products. Stiripentol API Price is not always fixed or binding as the Stiripentol Price is obtained through a variety of data sources. The Stiripentol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Stiripentol

Synonyms

49763-96-4, Diacomit, Bcx 2600, 1-(1,3-benzodioxol-5-yl)-4,4-dimethyl-1-penten-3-ol, 137767-55-6, Bcx-2600

Cas Number

131206-47-8

Unique Ingredient Identifier (UNII)

R02XOT8V8I

About Stiripentol

Stiripentol is an anticonvulsant drug used in the treatment of epilepsy as an adjunct therapy along with [DB00349] and [DB00313]. This drug is currently approved in the USA, Canada, and European countries as oral tablets marketed as Diacomit. FDA approval of this drug was granted on August 20, 2018,. Unrelated to other anticonvulsants, stiripentol belongs to the group of aromatic allylic alcohols and may potentiate the effect of other antiepileptic drugs (AEDs) due to pharmacokinetic interactions. It elevates the levels of gamma-aminobutyric acid (GABA), a major inhibitory neurotransmitter that regulates electrical activity in the central nervous system.

Stiripentol Manufacturers

A Stiripentol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Stiripentol, including repackagers and relabelers. The FDA regulates Stiripentol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Stiripentol 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 Stiripentol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Stiripentol Suppliers

A Stiripentol supplier is an individual or a company that provides Stiripentol active pharmaceutical ingredient (API) or Stiripentol finished formulations upon request. The Stiripentol suppliers may include Stiripentol API manufacturers, exporters, distributors and traders.

click here to find a list of Stiripentol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Stiripentol USDMF

A Stiripentol DMF (Drug Master File) is a document detailing the whole manufacturing process of Stiripentol active pharmaceutical ingredient (API) in detail. Different forms of Stiripentol DMFs exist exist since differing nations have different regulations, such as Stiripentol USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Stiripentol DMF submitted to regulatory agencies in the US is known as a USDMF. Stiripentol USDMF includes data on Stiripentol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Stiripentol USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Stiripentol suppliers with USDMF on PharmaCompass.

Stiripentol WC

A Stiripentol written confirmation (Stiripentol WC) is an official document issued by a regulatory agency to a Stiripentol manufacturer, verifying that the manufacturing facility of a Stiripentol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Stiripentol APIs or Stiripentol finished pharmaceutical products to another nation, regulatory agencies frequently require a Stiripentol WC (written confirmation) as part of the regulatory process.

click here to find a list of Stiripentol suppliers with Written Confirmation (WC) on PharmaCompass.

Stiripentol NDC

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 Stiripentol as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Stiripentol API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Stiripentol 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Stiripentol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Stiripentol NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Stiripentol suppliers with NDC on PharmaCompass.

Stiripentol GMP

Stiripentol 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 Stiripentol GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Stiripentol GMP manufacturer or Stiripentol GMP API supplier for your needs.

Stiripentol CoA

A Stiripentol CoA (Certificate of Analysis) is a formal document that attests to Stiripentol's compliance with Stiripentol specifications and serves as a tool for batch-level quality control.

Stiripentol CoA mostly includes findings from lab analyses of a specific batch. For each Stiripentol 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.

Stiripentol may be tested according to a variety of international standards, such as European Pharmacopoeia (Stiripentol EP), Stiripentol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Stiripentol USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
Ask Us for Pharmaceutical Supplier and Partner
Ask Us, Find A Supplier / Partner
No Commissions, No Strings Attached, Get Connected for FREE

What are you looking for?

How can we help you?

The request can't be empty

Please read our Privacy Policy carefully

You must agree to the privacy policy

The name can't be empty
The company can't be empty.
The email can't be empty Please enter a valid email.
The mobile can't be empty