Find Gabapentin Enacarbil manufacturers, exporters & distributors on PharmaCompass

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25 RELATED EXCIPIENT COMPANIES

41EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 478296-72-9, Horizant, Regnite, Xp-13512, Solzira, Xp13512
Molecular Formula
C16H27NO6
Molecular Weight
329.39  g/mol
InChI Key
TZDUHAJSIBHXDL-UHFFFAOYSA-N
FDA UNII
75OCL1SPBQ

Gabapentin Enacarbil
Gabapentin enacarbil is marketed under the name Horizant. It is a prodrug of gabapentin, and indicated in adults for the treatment of Restless Legs Syndrome (RLS) and postherpetic neuralgia (PHN).
1 2D Structure

Gabapentin Enacarbil

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-[1-[[1-(2-methylpropanoyloxy)ethoxycarbonylamino]methyl]cyclohexyl]acetic acid
2.1.2 InChI
InChI=1S/C16H27NO6/c1-11(2)14(20)22-12(3)23-15(21)17-10-16(9-13(18)19)7-5-4-6-8-16/h11-12H,4-10H2,1-3H3,(H,17,21)(H,18,19)
2.1.3 InChI Key
TZDUHAJSIBHXDL-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC(C)C(=O)OC(C)OC(=O)NCC1(CCCCC1)CC(=O)O
2.2 Other Identifiers
2.2.1 UNII
75OCL1SPBQ
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 1-(((alpha-isobutanoyloxyethoxy)carbonyl)aminomethyl)-1-cyclohexaneacetic Acid

2. Xp 10569

3. Xp 11084

4. Xp 11239

5. Xp 12464

6. Xp 13512

7. Xp-10569

8. Xp-11084

9. Xp-11239

10. Xp-12464

11. Xp-13512

12. Xp10569

13. Xp11084

14. Xp11239

15. Xp12464

16. Xp13512

2.3.2 Depositor-Supplied Synonyms

1. 478296-72-9

2. Horizant

3. Regnite

4. Xp-13512

5. Solzira

6. Xp13512

7. Asp8825

8. Xp 13512

9. Gsk1838262

10. Asp-8825

11. 75ocl1spbq

12. Gsk-1838262

13. Chebi:68840

14. 2-(1-((((1-(isobutyryloxy)ethoxy)carbonyl)amino)methyl)cyclohexyl)acetic Acid

15. 2-[1-[[1-(2-methylpropanoyloxy)ethoxycarbonylamino]methyl]cyclohexyl]acetic Acid

16. {1-[({[1-(isobutyryloxy)ethoxy]carbonyl}amino)methyl]cyclohexyl}acetic Acid

17. (1-(((((1rs)-1-((2-methylpropanoyl)oxy)ethoxy)carbonyl)amino)methyl)cyclohexyl)acetic Acid

18. (1-{[({(1rs)-1-[isobutyryloxy]ethoxy}carbonyl) Amino]methyl}cyclohexyl)acetic Acid

19. Cyclohexaneacetic Acid, 1-((((1-(2-methyl-1-oxopropoxy)ethoxy)carbonyl)amino)methyl)-

20. Gabapentin Encarbil

21. Unii-75ocl1spbq

22. Gsk 1838262

23. Gabapentin Enacarbil [usan:inn]

24. Gabapentin-encarbil

25. Horizant (tn)

26. Asp 8825

27. Gabapentine Enacarbil

28. Gabapentina Enacarbilo

29. Gabapentinum Enacarbilum

30. Schembl25455

31. Gtpl7560

32. Chembl1628502

33. Gabapentin Encarbil [mi]

34. Dtxsid30870359

35. Gabapentin Enacarbil [inn]

36. Gabapentin Enacarbil [jan]

37. Gabapentin Enacarbil [usan]

38. Bcp12845

39. Gabapentin Enacarbil [vandf]

40. Gabapentin Enacarbil [mart.]

41. Mfcd09954124

42. Xp-053

43. Gabapentin Enacarbil [who-dd]

44. Akos025290727

45. Gabapentin Enacarbil (jan/usan/inn)

46. Cs-1698

47. Db08872

48. Pb32822

49. 1-[[[[1-(2-methyl-1-oxopropoxy)ethoxy]carbonyl]amino]methyl]cyclohexaneacetic Acid

50. Ncgc00532500-01

51. Ac-27644

52. As-35192

53. Gabapentin Enacarbil [orange Book]

54. Hy-16216

55. Db-070861

56. Ft-0753836

57. A20372

58. D09539

59. 296g729

60. Q5515257

61. {[(1-isobutanoyloxyethoxy)carbonyl]aminomethyl}-1-cyclohexane Acetic Acid

62. {[(alpha-isobutanoyloxyethoxy)carbonyl]aminomethyl}-1-cyclohexane Acetic Acid

63. 1-{[(alpha-isobutanovloxyethoxy)carbonyl]aminomethyl}-1-cyclohexane Acetic Acid

64. 1-{[(alpha-isobutanoyloxyethoxy)carbonyl]aminomethyl}-1-cyclohexane Acetic Acid

65. 1-{[(alpha-isobutanoyloxyethoxy)carbonyl]aminomethyl}-1-cyclohexaneacetic Acid

66. 2-[1-[[[1-[(2-methylpropanoyl)oxy]ethoxy]carbonylamino]methyl]cyclohexyl]acetic Acid

2.4 Create Date
2006-10-25
3 Chemical and Physical Properties
Molecular Weight 329.39 g/mol
Molecular Formula C16H27NO6
XLogP33.1
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count6
Rotatable Bond Count9
Exact Mass329.18383758 g/mol
Monoisotopic Mass329.18383758 g/mol
Topological Polar Surface Area102 Ų
Heavy Atom Count23
Formal Charge0
Complexity428
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count1
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameHorizant
Drug LabelHORIZANT (gabapentin enacarbil) is a prodrug of gabapentin. Gabapentin enacarbil is described as (1-{[({(1RS)-1-[(2-Methylpropanoyl)oxy]ethoxy}carbonyl)amino]methyl} cyclohexyl) acetic acid. It has a molecular formula of C16H27NO6 and a molecular wei...
Active IngredientGabapentin enacarbil
Dosage FormTablet, extended release
RouteOral
Strength600mg; 300mg
Market StatusPrescription
CompanyXenoport

2 of 2  
Drug NameHorizant
Drug LabelHORIZANT (gabapentin enacarbil) is a prodrug of gabapentin. Gabapentin enacarbil is described as (1-{[({(1RS)-1-[(2-Methylpropanoyl)oxy]ethoxy}carbonyl)amino]methyl} cyclohexyl) acetic acid. It has a molecular formula of C16H27NO6 and a molecular wei...
Active IngredientGabapentin enacarbil
Dosage FormTablet, extended release
RouteOral
Strength600mg; 300mg
Market StatusPrescription
CompanyXenoport

4.2 Drug Indication

For the treatment of adult Restless Legs Syndrome (RLS) and postherpetic neuralgia (PHN).


FDA Label


5 Pharmacology and Biochemistry
5.1 Pharmacology

Since gabapentin enacarbil is a prodrug of gabapentin, it's physiological effects are the same as gabapentin. Concerning PHN, gabapentin prevents allodynia and hyperalgesia.


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]; Anti-epileptic Agent [EPC]
5.3 Absorption, Distribution and Excretion

Absorption

Gabapentin enacarbil is absorbed in the intestines by active transport through the proton-linked monocarboxylate transporter, MCT-1.


Route of Elimination

Gabapentin enacarbil is eliminated primarily in the urine (94%) and to a lesser extent in the feces (5%).


Volume of Distribution

The volume of distribution is 76L.


Clearance

Renal clearance of gabapentin is 5 to 7 L/hr.


5.4 Metabolism/Metabolites

Gabapentin enacarbil does not interact with any of the major cytochrome P450 enzymes.


5.5 Biological Half-Life

The elimination half-life of gabapentin is 5.1 to 6.0 hours.


5.6 Mechanism of Action

Although the exact mechanism of action of gabapentin in RLS and PHN is unknown, it is presumed to involve the descending noradrenergic system, resulting in the activation of spinal alpha2-adrenergic receptors.


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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 300M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 300MG

USFDA APPLICATION NUMBER - 22399

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 600M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 600MG

USFDA APPLICATION NUMBER - 22399

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Looking for 478296-72-9 / Gabapentin Enacarbil API manufacturers, exporters & distributors?

Gabapentin Enacarbil manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Gabapentin Enacarbil 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 Gabapentin Enacarbil manufacturer or Gabapentin Enacarbil supplier for your needs.

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

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

API | Excipient name

Gabapentin Enacarbil

Synonyms

478296-72-9, Horizant, Regnite, Xp-13512, Solzira, Xp13512

Cas Number

478296-72-9

Unique Ingredient Identifier (UNII)

75OCL1SPBQ

About Gabapentin Enacarbil

Gabapentin enacarbil is marketed under the name Horizant. It is a prodrug of gabapentin, and indicated in adults for the treatment of Restless Legs Syndrome (RLS) and postherpetic neuralgia (PHN).

Gabapentin Enacarbil Manufacturers

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

Gabapentin Enacarbil Suppliers

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

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

Gabapentin Enacarbil USDMF

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

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

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

Gabapentin Enacarbil WC

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

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

Gabapentin Enacarbil 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 Gabapentin Enacarbil as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Gabapentin Enacarbil 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 Gabapentin Enacarbil 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 Gabapentin Enacarbil and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Gabapentin Enacarbil NDC to their finished compounded human drug products, they may choose to do so.

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

Gabapentin Enacarbil GMP

Gabapentin Enacarbil 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 Gabapentin Enacarbil 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 Gabapentin Enacarbil GMP manufacturer or Gabapentin Enacarbil GMP API supplier for your needs.

Gabapentin Enacarbil CoA

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

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

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