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Chemistry

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Also known as: 4-methylpyrazole, 4-methyl-1h-pyrazole, 7554-65-6, Antizol, 1h-pyrazole, 4-methyl-, 4-methylpyrazol
Molecular Formula
C4H6N2
Molecular Weight
82.10  g/mol
InChI Key
RIKMMFOAQPJVMX-UHFFFAOYSA-N
FDA UNII
83LCM6L2BY

Fomepizole
A pyrazole and competitive inhibitor of ALCOHOL DEHYDROGENASE that is used for the treatment of poisoning by ETHYLENE GLYCOL or METHANOL.
Fomepizole is an Antidote.
1 2D Structure

Fomepizole

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
4-methyl-1H-pyrazole
2.1.2 InChI
InChI=1S/C4H6N2/c1-4-2-5-6-3-4/h2-3H,1H3,(H,5,6)
2.1.3 InChI Key
RIKMMFOAQPJVMX-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC1=CNN=C1
2.2 Other Identifiers
2.2.1 UNII
83LCM6L2BY
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 4 Methylpyrazole

2. 4 Methylpyrazole Monohydrochloride

3. 4-methylpyrazole

4. 4-methylpyrazole Monohydrochloride

5. Antizol

2.3.2 Depositor-Supplied Synonyms

1. 4-methylpyrazole

2. 4-methyl-1h-pyrazole

3. 7554-65-6

4. Antizol

5. 1h-pyrazole, 4-methyl-

6. 4-methylpyrazol

7. Fomepizol

8. Fomepizolum

9. Fomepizol [inn-spanish]

10. Fomepizolum [inn-latin]

11. Antizol-vet

12. 4-mp

13. 4-methyl Pyrazole

14. Pyrazole, 4-methyl-

15. Chebi:5141

16. Mfcd00005245

17. Nsc-760365

18. 83lcm6l2by

19. Fomepizole [usan:inn]

20. Antizol (tn)

21. Einecs 231-445-0

22. Unii-83lcm6l2by

23. Brn 0105204

24. Fomepizole [usan:inn:ban]

25. 4-methyl-pyrazole

26. Fomepizole, 99%

27. Fomepizole (antizol)

28. 4-methyl-1h_pyrazole

29. Fomepizole [mi]

30. Fomepizole [inn]

31. Fomepizole [jan]

32. Fomepizole [usan]

33. Lopac-m-1387

34. M0774

35. Fomepizole [vandf]

36. Ec 231-445-0

37. Fomepizole [mart.]

38. Chembl1308

39. Fomepizole [who-dd]

40. Lopac0_000723

41. 5-23-05-00031 (beilstein Handbook Reference)

42. Mls001335923

43. Fomepizole (jan/usan/inn)

44. Fomepizole [green Book]

45. Dtxsid3040649

46. Fomepizole [orange Book]

47. Gtpl11705

48. Hms3713h14

49. Hms3868m13

50. Pharmakon1600-01506159

51. Zinc897288

52. Act05848

53. Act08853

54. Albb-016317

55. Hy-b0876

56. Bdbm50226186

57. Cl3422

58. Nsc760365

59. S1717

60. Stk256626

61. Akos000265586

62. Ab00390

63. Ac-4833

64. Ccg-204808

65. Db01213

66. Nsc 760365

67. Sdccgsbi-0050701.p003

68. Ncgc00015646-01

69. Ncgc00015646-02

70. Ncgc00015646-03

71. Ncgc00015646-04

72. Ncgc00015646-10

73. Ncgc00162231-01

74. 615557-09-0

75. Smr000059088

76. Sy006499

77. 4-methyl-1h-pyrazole;4-methylpyrazole

78. Sbi-0050701.p002

79. Db-022514

80. Db-094915

81. A9615

82. Am20100737

83. Bb 0257933

84. Ft-0626518

85. En300-50246

86. C07837

87. D00707

88. Ab00918526_06

89. Ab00918526_07

90. 554m656

91. A855125

92. Q416410

93. Q-101886

94. Z969563038

95. 4pz

2.4 Create Date
2005-03-25
3 Chemical and Physical Properties
Molecular Weight 82.10 g/mol
Molecular Formula C4H6N2
XLogP31.4
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count1
Rotatable Bond Count0
Exact Mass82.053098200 g/mol
Monoisotopic Mass82.053098200 g/mol
Topological Polar Surface Area28.7 Ų
Heavy Atom Count6
Formal Charge0
Complexity44.8
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NameAntizol
PubMed HealthFomepizole (Injection)
Drug ClassesToxicology-Antidote Agent
Drug LabelAntizol (fomepizole) Injection is a competitive inhibitor of alcohol dehydrogenase.The chemical name of fomepizole is 4-methylpyrazole. It has the molecular formula C4H6N2 and a molecular weight of 82.1. The structural formula is:It is a clear to y...
Active IngredientFomepizole
Dosage FormInjectable
RouteInjection
Strength1.5gm/1.5ml (1gm/ml)
Market StatusPrescription
CompanyPaladin Labs

2 of 4  
Drug NameFomepizole
Drug LabelFomepizole Injection is a competitive inhibitor of alcohol dehydrogenase. The chemical name of fomepizole is 4-methylpyrazole. It has the molecular formula C4H6N2 and a molecular weight of 82.1. The structural formula is:It is a clear to yellow liqui...
Active IngredientFomepizole
Dosage FormInjectable
RouteInjection
Strength1.5gm/1.5ml (1gm/ml)
Market StatusPrescription
CompanyNavinta; Mylan Institutional; Luitpold

3 of 4  
Drug NameAntizol
PubMed HealthFomepizole (Injection)
Drug ClassesToxicology-Antidote Agent
Drug LabelAntizol (fomepizole) Injection is a competitive inhibitor of alcohol dehydrogenase.The chemical name of fomepizole is 4-methylpyrazole. It has the molecular formula C4H6N2 and a molecular weight of 82.1. The structural formula is:It is a clear to y...
Active IngredientFomepizole
Dosage FormInjectable
RouteInjection
Strength1.5gm/1.5ml (1gm/ml)
Market StatusPrescription
CompanyPaladin Labs

4 of 4  
Drug NameFomepizole
Drug LabelFomepizole Injection is a competitive inhibitor of alcohol dehydrogenase. The chemical name of fomepizole is 4-methylpyrazole. It has the molecular formula C4H6N2 and a molecular weight of 82.1. The structural formula is:It is a clear to yellow liqui...
Active IngredientFomepizole
Dosage FormInjectable
RouteInjection
Strength1.5gm/1.5ml (1gm/ml)
Market StatusPrescription
CompanyNavinta; Mylan Institutional; Luitpold

4.2 Drug Indication

Antizol is indicated as an antidote for ethylene glycol (such as antifreeze) or methanol poisoning, or for use in suspected ethylene glycol or methanol ingestion, either alone or in combination with hemodialysis


5 Pharmacology and Biochemistry
5.1 Pharmacology

Fomepizole is a competitive inhibitor of alcohol dehydrogenase, the enzyme that catalyzes the initial steps in the metabolism of ethylene glycol and methanol to their toxic metabolites. Ethylene glycol is first metabolized to glycoaldehyde which then undergoes further oxidation to glycolate, glyoxylate, and oxalate. Glycolate and oxalate are primarily responsible for metabolic acidosis and renal damage seen in ethylene glycol toxicity. {01}{03} Methanol is first metabolized to formaldehyde and then undergoes subsequent oxidation via formaldehyde dehydrogenase to become formic acid. It is formic acid that is primarily responsible for the metabolic acidosis and visual disturbances that are associated with methanol poisoning.


5.2 MeSH Pharmacological Classification

Antidotes

Agents counteracting or neutralizing the action of POISONS. (See all compounds classified as Antidotes.)


Enzyme Inhibitors

Compounds or agents that combine with an enzyme in such a manner as to prevent the normal substrate-enzyme combination and the catalytic reaction. (See all compounds classified as Enzyme Inhibitors.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
FOMEPIZOLE
5.3.2 FDA UNII
83LCM6L2BY
5.3.3 Pharmacological Classes
Antidote [EPC]
5.4 ATC Code

V - Various

V03 - All other therapeutic products

V03A - All other therapeutic products

V03AB - Antidotes

V03AB34 - Fomepizole


5.5 Absorption, Distribution and Excretion

Absorption

Rapid and complete


Route of Elimination

In healthy volunteers, only 1-3.5% of the administered dose of Antizol (7-20 mg/kg oral and IV) was excreted unchanged in the urine, indicating that metabolism is the major route of elimination. In humans, the primary metabolite of Antizol is 4-carboxypyrazole (approximately 80-85% of administered dose), which is excreted in the urine. The metabolites of Antizol are excreted renally.


Volume of Distribution

0.6 to 1.02 L/kg


5.6 Metabolism/Metabolites

Primarily hepatic. the primary metabolite is 4-carboxypyrazole (approximately 80 to 85% of an administered dose). Minor metabolites include 4-hydroxymethylpyrazole and the N -glucuronide conjugates of 4-carboxypyrazole and 4-hydroxymethylpyrazole.


5.7 Biological Half-Life

The plasma half-life of Antizol varies with dose, even in patients with normal renal function, and has not been calculated.


5.8 Mechanism of Action

Antizol (fomepizole) is a competitive inhibitor of alcohol dehydrogenase. Alcohol dehydrogenase catalyzes the oxidation of ethanol to acetaldehyde. Alcohol dehydrogenase also catalyzes the initial steps in the metabolism of ethylene glycol and methanol to their toxic metabolites.


API SUPPLIERS

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Navinta Llc

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Navinta Llc

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DMF Number : 19683

Submission : 2006-08-10

Status : Active

Type : II

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DMF Review : Complete

Rev. Date : 2024-09-17

Pay. Date : 2024-07-11

DMF Number : 40058

Submission : 2024-07-24

Status : Active

Type : II

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DMF Review : Complete

Rev. Date : 2021-06-15

Pay. Date : 2021-04-29

DMF Number : 35383

Submission : 2020-11-30

Status : Active

Type : II

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DMF Number : 20305

Submission : 2007-02-26

Status : Active

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DMF Review : Complete

Rev. Date : 2013-01-08

Pay. Date : 2012-12-18

DMF Number : 19472

Submission : 2006-05-24

Status : Active

Type : II

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NDC API

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FOMEPIZOLE

NDC Package Code : 14096-107

Start Marketing Date : 2010-08-01

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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FOMEPIZOLE

NDC Package Code : 65732-702

Start Marketing Date : 2008-06-01

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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Apicore

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Fomepizole

About the Company : Apicore LLC, a wholly owned subsidiary of RK Pharma Inc is a leading process R&D and API manufacturing service provider for the worldwide pharmaceutical industry. We offer a wide p...

Apicore LLC, a wholly owned subsidiary of RK Pharma Inc is a leading process R&D and API manufacturing service provider for the worldwide pharmaceutical industry. We offer a wide portfolio of services ranging from API’s for the generic industry to custom synthesis for early phase pharmaceutical research and branded products. Our USFDA approved facilities in India (Visakhapatnam, Andhra Pradesh and Vadodara, Gujarat) are both equipped with state-of-the-art analytical and research capabilities. While our worldwide network of locations seamlessly integrate with each other, each unit also independently houses a full
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About the Company : A globally renowned manufacturer of Small Volume Parenterals (SVPs), Gland Pharma was founded in 1978 at Hyderabad by a visionary, PVN Raju, who has always thought far ahead of his...

A globally renowned manufacturer of Small Volume Parenterals (SVPs), Gland Pharma was founded in 1978 at Hyderabad by a visionary, PVN Raju, who has always thought far ahead of his time. Since inception, Gland Pharma stands testimony to the founder’s exemplary commitment to Quality, having emerged as a global player with presence in about 90 countries in five continents. We have a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions and ophthalmic solutions.
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Viatris

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About the Company : In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (N...

In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020.
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  • Development Update

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N-Acetylcysteine is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Drug Overdose.


Lead Product(s): Acetylcysteine,Fomepizole

Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Johnson & Johnson

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 26, 2022

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Richard Dart, MD, PhD

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Product Name : Undisclosed

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Upfront Cash : Inapplicable

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CAS Number : 1653-16-3

End Use API : Fomepizole

About The Company : At Infinium Pharmachem Pvt. Ltd., we are well focused to Iodine chemistry & this is the only core area of ours. We are working as CRAMS, but our domain is very ...

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FOMEPIZOLE

Brand Name : FOMEPIZOLE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 1.5GM/1.5ML (1GM/ML)

Packaging :

Approval Date : 2007-12-14

Application Number : 78368

Regulatory Info : RX

Registration Country : USA

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Eusa Pharma

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Brand Name : Fomepizole Eusa Pharma

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Dosage Strength : 5 mg/ml

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Brand Name : FOMEPIZOLE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 1.5GM/1.5ML (1GM/ML)

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Approval Date : 2023-07-06

Application Number : 216791

Regulatory Info : RX

Registration Country : USA

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Navinta

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FOMEPIZOLE

Brand Name : FOMEPIZOLE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 1.5GM/1.5ML (1GM/ML)

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Approval Date : 2008-03-06

Application Number : 78537

Regulatory Info : RX

Registration Country : USA

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FOMEPIZOLE

Brand Name : ANTIZOL

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 1.5GM/1.5ML (1GM/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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Approval Date : 1997-12-04

Application Number : 20696

Regulatory Info : DISCN

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Brand Name : FOMEPIZOLE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 1.5GM/1.5ML (1GM/ML)

Packaging :

Approval Date : 2008-03-03

Application Number : 78639

Regulatory Info : RX

Registration Country : USA

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Farbe Firma

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Farbe Firma

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Registration Country : India

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Fomepizole manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Fomepizole

Synonyms

4-methylpyrazole, 4-methyl-1h-pyrazole, 7554-65-6, Antizol, 1h-pyrazole, 4-methyl-, 4-methylpyrazol

Cas Number

7554-65-6

Unique Ingredient Identifier (UNII)

83LCM6L2BY

About Fomepizole

A pyrazole and competitive inhibitor of ALCOHOL DEHYDROGENASE that is used for the treatment of poisoning by ETHYLENE GLYCOL or METHANOL.

Fomepizole Manufacturers

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

Fomepizole Suppliers

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

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

Fomepizole USDMF

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

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

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

Fomepizole 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 Fomepizole as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Fomepizole GMP

Fomepizole 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 Fomepizole 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 Fomepizole GMP manufacturer or Fomepizole GMP API supplier for your needs.

Fomepizole CoA

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

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

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