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    Chemistry

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    Also known as: 76963-41-2, Axid, Zanizal, Nizax, Ly-139037, Niaztidine
    Molecular Formula
    C12H21N5O2S2
    Molecular Weight
    331.5  g/mol
    InChI Key
    SGXXNSQHWDMGGP-IZZDOVSWSA-N
    Nizatidine
    A histamine H2 receptor antagonist with low toxicity that inhibits gastric acid secretion. The drug is used for the treatment of duodenal ulcers.
    1 2D Structure

    Nizatidine

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (E)-1-N'-[2-[[2-[(dimethylamino)methyl]-1,3-thiazol-4-yl]methylsulfanyl]ethyl]-1-N-methyl-2-nitroethene-1,1-diamine
    2.1.2 InChI
    InChI=1S/C12H21N5O2S2/c1-13-11(6-17(18)19)14-4-5-20-8-10-9-21-12(15-10)7-16(2)3/h6,9,13-14H,4-5,7-8H2,1-3H3/b11-6+
    2.1.3 InChI Key
    SGXXNSQHWDMGGP-IZZDOVSWSA-N
    2.1.4 Canonical SMILES
    CNC(=C[N+](=O)[O-])NCCSCC1=CSC(=N1)CN(C)C
    2.1.5 Isomeric SMILES
    CN/C(=C\[N+](=O)[O-])/NCCSCC1=CSC(=N1)CN(C)C
    2.2 Synonyms
    2.2.1 MeSH Synonyms

    1. Axid

    2. Ly 139037

    3. Ly-139037

    4. Ly139037

    5. N-(2-(((2-((dimethylamino)methyl)-4-thiazolyl)methyl)thio)ethyl)-n'-methyl-2-nitro-1,1-ethenediamine

    2.2.2 Depositor-Supplied Synonyms

    1. 76963-41-2

    2. Axid

    3. Zanizal

    4. Nizax

    5. Ly-139037

    6. Niaztidine

    7. Nizatidinum

    8. Nizatidina

    9. Ze-101

    10. Zl-101

    11. (e)-n-(2-(((2-((dimethylamino)methyl)thiazol-4-yl)methyl)thio)ethyl)-n'-methyl-2-nitroethene-1,1-diamine

    12. (e)-n-(2-(((2-((dimethylamino)methyl)thiazol-4-yl)methyl)thio)ethyl)-n-methyl-2-nitroethene-1,1-diamine

    13. Dimethyl[(4-{[(2-{[(e)-1-(methylamino)-2-nitroethenyl]amino}ethyl)sulfanyl]methyl}-1,3-thiazol-2-yl)methyl]amine

    14. N-(4-(6-methylamino-7-nitro-2-thia-5-aza-6-hepten-1-yl)-2-thiazolylmethyl)-n,n-dimethylamine

    15. Smr000466384

    16. Acinon (tn)

    17. Axid (tn)

    18. Chebi:7601

    19. Mfcd00865660

    20. Ncgc00016934-01

    21. Cas-76963-41-2

    22. Prestwick2_000921

    23. Schembl769

    24. Schembl770

    25. Chembl653

    26. Ly-139037, Nizatidine

    27. Mls000759518

    28. Mls001076680

    29. Mls001424001

    30. Bidd:gt0761

    31. Nizatidine, Analytical Standard

    32. Gtpl7248

    33. Nizatidine (jp17/usp/inn)

    34. Nizatidine For System Suitability

    35. Hms2051k04

    36. Hms2094a15

    37. Hms2235n05

    38. Pharmakon1600-01505985

    39. Hy-b0310

    40. Zinc1530736

    41. Nsc759289

    42. Akos015900643

    43. Ac-5272

    44. Ccg-100836

    45. Db00585

    46. Hs-0083

    47. Nc00086

    48. Ncgc00016934-02

    49. (e)-n-{2-[({2-[(dimethylamino)methyl]-1,3-thiazol-4-yl}methyl)thio]ethyl}-n'-methyl-2-nitroethene-1,1-diamine

    50. Bn166185

    51. Sbi-0206937.p001

    52. C07270

    53. D00440

    54. Ab00698253-07

    55. Ab00698253_09

    56. Benzenesulfonylchloride,4-hydroxy-3-nitro-(9ci)

    57. 963n412

    58. A838919

    59. L000761

    60. Sr-01000765410

    61. Q1188290

    62. Sr-01000765410-4

    63. Brd-k73589491-001-05-4

    64. Brd-k92193792-001-01-7

    65. (e)-1-n'-[2-[[2-[(dimethylamino)methyl]-1,3-thiazol-4-yl]methylsulfanyl]ethyl]-1-n-methyl-2-nitroethene-1,1-diamine

    66. (e)-n-(2-((2-((dimethylamino)methyl)thiazol-4-yl)methylthio)ethyl)-n-methyl-2-nitroethene-1,1-diamine

    67. (e)-n1'-[2-[[2-[(dimethylamino)methyl]-1,3-thiazol-4-yl]methylsulfanyl]ethyl]-n1-methyl-2-nitro-ethene-1,1-diamine

    68. (e)-n1'-[2-[[2-[(dimethylamino)methyl]-4-thiazolyl]methylthio]ethyl]-n1-methyl-2-nitroethene-1,1-diamine

    69. 1,1-ethenediamine, N'-[2-[[[2-[(dimethylamino)methyl]-4-thiazolyl]methyl]thio]ethyl]-n-methyl-2-nitro-

    70. N-(2-(((2-((dimethylamino)methyl)thiazol-4-yl)methyl)thio)ethyl)-n-methyl-2-nitroethene-1,1-diamine

    71. N-{2-[({2-[(dimethylamino)methyl]-1,3-thiazol-4-yl}methyl)sulfanyl]ethyl}-n'-methyl-2-nitroethene-1,1-diamine

    2.3 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 331.5 g/mol
    Molecular Formula C12H21N5O2S2
    XLogP31.6
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count9
    Exact Mass331.11366728 g/mol
    Monoisotopic Mass331.11366728 g/mol
    Topological Polar Surface Area140 Ų
    Heavy Atom Count21
    Formal Charge0
    Complexity349
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count1
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 6  
    Drug NameAxid
    PubMed HealthNizatidine (By mouth)
    Drug ClassesAntiulcer, Gastric Acid Secretion Inhibitor
    Drug LabelNizatidine (USP) is a histamine H2-receptor antagonist. Chemically, it is N-[2-[[[2-[(dimethylamino)methyl]-4-thiazolyl]methyl]thio]ethyl]-N'-methyl-2-nitro-1,1-ethenediamine. The structural formula is as follows: Nizatidine has the empirical formula
    Active IngredientNizatidine
    Dosage FormSolution
    RouteOral
    Strength15mg/ml
    Market StatusPrescription
    CompanyBraintree

    2 of 6  
    Drug NameAxid ar
    Active IngredientNizatidine
    Dosage FormTablet
    RouteOral
    Strength75mg
    Market StatusOver the Counter
    CompanyPfizer

    3 of 6  
    Drug NameNizatidine
    PubMed HealthNizatidine (By mouth)
    Drug ClassesAntiulcer, Gastric Acid Secretion Inhibitor
    Drug LabelNizatidine USP is a histamine H2-receptor antagonist. Chemically, it is N-[2-[[[2-[(Dimethylamino)methyl]-4-thiazolyl]methyl]thio]ethyl]-N'-methyl-2-nitro-1,1-ethenediamine. The structural formula is represented below:C12H21N5O2S2...
    Active IngredientNizatidine
    Dosage FormCapsule; Solution
    RouteOral
    Strength150mg; 300mg; 15mg/ml
    Market StatusPrescription
    CompanyAmneal Pharms; Mylan Pharms; Ani Pharms; Sandoz; Watson Labs; Glenmark Generics; Dr Reddys Labs

    4 of 6  
    Drug NameAxid
    PubMed HealthNizatidine (By mouth)
    Drug ClassesAntiulcer, Gastric Acid Secretion Inhibitor
    Drug LabelNizatidine (USP) is a histamine H2-receptor antagonist. Chemically, it is N-[2-[[[2-[(dimethylamino)methyl]-4-thiazolyl]methyl]thio]ethyl]-N'-methyl-2-nitro-1,1-ethenediamine. The structural formula is as follows: Nizatidine has the empirical formula
    Active IngredientNizatidine
    Dosage FormSolution
    RouteOral
    Strength15mg/ml
    Market StatusPrescription
    CompanyBraintree

    5 of 6  
    Drug NameAxid ar
    Active IngredientNizatidine
    Dosage FormTablet
    RouteOral
    Strength75mg
    Market StatusOver the Counter
    CompanyPfizer

    6 of 6  
    Drug NameNizatidine
    PubMed HealthNizatidine (By mouth)
    Drug ClassesAntiulcer, Gastric Acid Secretion Inhibitor
    Drug LabelNizatidine USP is a histamine H2-receptor antagonist. Chemically, it is N-[2-[[[2-[(Dimethylamino)methyl]-4-thiazolyl]methyl]thio]ethyl]-N'-methyl-2-nitro-1,1-ethenediamine. The structural formula is represented below:C12H21N5O2S2...
    Active IngredientNizatidine
    Dosage FormCapsule; Solution
    RouteOral
    Strength150mg; 300mg; 15mg/ml
    Market StatusPrescription
    CompanyAmneal Pharms; Mylan Pharms; Ani Pharms; Sandoz; Watson Labs; Glenmark Generics; Dr Reddys Labs

    4.2 Therapeutic Uses

    Anti-Ulcer Agents; Histamine H2 Antagonists

    National Library of Medicine's Medical Subject Headings online file (MeSH, 1999)

    In the Zollinger-Ellison syndrome and other acid peptic disorders, the efficacy of nizatidine would be expected to be similar to that of ranitidine, but confirmation in clinical studies is required. Nizatidine relieves symptoms and heals lesions in patients with mild to moderate reflux esophagitis.

    American Medical Association, Council on Drugs. AMA Drug Evaluations Annual 1994. Chicago, IL: American Medical Association, 1994., p. 903

    Histamine H2-receptor antagonists are indicated in the short-term treatment of active duodenal ulcer. They are also indicated (at reduced dosage) in the prevention of duodenal ulcer recurrence in selected patients. /Histamine H2-receptor antagonists; Included in US product labeling/

    USP Convention. USPDI - Drug Information for the Health Care Professional. 16th ed. Volume I. Rockville, MD: U.S. Pharmaceutical Convention, Inc. 1996 (Plus updates)., p. 1611

    Nizatidine ... /is/ indicated in the short-term treatment of active benign gastric ulcer. /Included in US product labeling/

    USP Convention. USPDI - Drug Information for the Health Care Professional. 16th ed. Volume I. Rockville, MD: U.S. Pharmaceutical Convention, Inc. 1996 (Plus updates)., p. 1611

    For more Therapeutic Uses (Complete) data for NIZATIDINE (8 total), please visit the HSDB record page.

    4.3 Drug Warning

    Nizatidine should be used with caution and the dose and/or frequency of administration reduced in patients with renal impairment (ie., creatinine clearance less than 50 ml/min), since the drug is excreted principally by the kidneys.

    McEvoy G.K. (ed.). American Hospital Formulary Service-Drug Information 96. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 1996 (Plus Supplements)., p. 2174

    Symptomatic response to nizatidine should not be interpreted as precluding the presence of gastric malignancy.

    McEvoy G.K. (ed.). American Hospital Formulary Service-Drug Information 96. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 1996 (Plus Supplements)., p. 2174

    Rhinitis, pharyngitis, sinusitis, or increased cough has occurred in about 2-10% of patients receiving nizatidine. Diaphoresis occurred more often with nizatidine therapy than with placebo but was not considered drug related because of its association with other concurrent adverse events (e.g., fever, anxiety). Pain, including back or chest pain, has been reported in approximately 2-4% of patients receiving nizatidine. Other adverse events reported in patients receiving nizatidine include myalgia, fever, infection, amblyopia, hyperuricemia, and impotence. In most studies, the incidence of these adverse effects, and of surgical procedures or accidental injuries, was similar in patients receiving nizatidine or placebo. Asymptomatic ventricular tachycardia, decreased libido, and gynecomastia have been reported rarely.

    McEvoy G.K. (ed.). American Hospital Formulary Service-Drug Information 96. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 1996 (Plus Supplements)., p. 2174

    Urticaria occurred more often with nizatidine therapy (0.5% of patients) than with placebo (0.1% of patients) in placebo-controlled clinical studies. Rash, pruritus, or exfoliative dermatitis has occurred in up to 2% of patients receiving nizatidine. Serum sickness-like reactions, anaphylaxis, bronchospasm, laryngeal edema, eosinophilia, vasculitis, and erythema multiforme also have been reported rarely.

    McEvoy G.K. (ed.). American Hospital Formulary Service-Drug Information 96. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 1996 (Plus Supplements)., p. 2174

    For more Drug Warnings (Complete) data for NIZATIDINE (7 total), please visit the HSDB record page.

    4.4 Drug Indication

    For the treatment of acid-reflux disorders (GERD), peptic ulcer disease, active benign gastric ulcer, and active duodenal ulcer.

    FDA Label

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Nizatidine is a competitive, reversible inhibitor of histamine at the histamine H2-receptors, particularly those in the gastric parietal cells. By inhibiting the action of histamine on stomach cells, nizatidine reduces stomach acid production. Nizatidine had no demonstrable antiandrogenic action. Full-dose therapy for the problems treated by nizatidine lasts no longer than 8 weeks. It has been demonstrated that treatment with a reduced dose of nizatidine is effective as maintenance therapy following healing of active duodenal ulcers.

    5.2 MeSH Pharmacological Classification

    Histamine H2 Antagonists

    Drugs that selectively bind to but do not activate histamine H2 receptors, thereby blocking the actions of histamine. Their clinically most important action is the inhibition of acid secretion in the treatment of gastrointestinal ulcers. Smooth muscle may also be affected. Some drugs in this class have strong effects in the central nervous system, but these actions are not well understood. (See all compounds classified as Histamine H2 Antagonists.)

    Anti-Ulcer Agents

    Various agents with different action mechanisms used to treat or ameliorate PEPTIC ULCER or irritation of the gastrointestinal tract. This has included ANTIBIOTICS to treat HELICOBACTER INFECTIONS; HISTAMINE H2 ANTAGONISTS to reduce GASTRIC ACID secretion; and ANTACIDS for symptomatic relief. (See all compounds classified as Anti-Ulcer Agents.)

    5.3 FDA Pharmacological Classification
    5.3.1 Pharmacological Classes
    Histamine-2 Receptor Antagonist [EPC]; Histamine H2 Receptor Antagonists [MoA]
    5.4 ATC Code

    A - Alimentary tract and metabolism

    A02 - Drugs for acid related disorders

    A02B - Drugs for peptic ulcer and gastro-oesophageal reflux disease (gord)

    A02BA - H2-receptor antagonists

    A02BA04 - Nizatidine

    5.5 Absorption, Distribution and Excretion

    Absorption

    Rapid (bioavailability of nizatidine exceeds 70%)

    Volume of Distribution

    0.8 to 1.5 L/kg

    Clearance

    40-60 L/h

    7 14 L/h [functionally anephric patients]

    Nizatidine has a duration of action of up to 10 hours. It is eliminated primarily by the kidneys; 90% of the administered dose (65% as unchanged drug) is recovered in the urine within 16 hours.

    American Medical Association, Council on Drugs. AMA Drug Evaluations Annual 1994. Chicago, IL: American Medical Association, 1994., p. 904

    Distribution of nizatidine into human body tissues and fluids has not been fully characterized. The apparent volume of distribution of the drug is reported to be 0.8-1.5 l/kg in adults and does not appear to be altered substantially in patients with renal dysfunction.

    McEvoy G.K. (ed.). American Hospital Formulary Service-Drug Information 96. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 1996 (Plus Supplements)., p. 2172

    In one study, the oral bioavailability of nizatidine exceeded 70% and was not affected by food or the anticholinergic drug, propantheline. Its apparent volume of distribution is 1.2 l/kg. Systemic clearance (10 ml/min/kg) is decreased in uremic patients and in the elderly.

    American Medical Association, Council on Drugs. AMA Drug Evaluations Annual 1994. Chicago, IL: American Medical Association, 1994., p. 904

    The safety and disposition of single oral doses of nizatidine were investigated in 8 young volunteers (aged 25-48 yr) who received 100-350 mg nizatidine and in 12 elderly volunteers (aged 66-79 yr) who received 100-300 mg. The nizatidine AUC was directly proportional to dose for both groups of volunteers. Calculated pharmacokinetic variables in the elderly versus the young were Tl/2 (1.9 versus 1.6 hr), apparent plasma clearance (32 versus 40 l/h) and apparent volume of distribution (1.2 versus 1.3 l/kg). The impaired renal function of some elderly volunteers prolonged nizatidine elimination and lowered its clearance. Renal impairment rather than advanced age per se was the predominant factor in decreasing the nizatidine elimination rate. No serious adverse effects occurred.

    PMID:2888796 Callaghan JT et al; J Clin Pharmacol 27 (Aug): 618-24 (1987)

    For more Absorption, Distribution and Excretion (Complete) data for NIZATIDINE (7 total), please visit the HSDB record page.

    5.6 Metabolism/Metabolites

    Hepatic. Less than 7% of an oral dose is metabolized as N2-monodes-methylnizatidine, an H2-receptor antagonist, which is the principal metabolite excreted in the urine. Other likely metabolites are the N2-oxide (less than 5% of the dose) and the S-oxide (less than 6% of the dose).

    Nizatidine is metabolized in the liver to N-desmethylnizatidine, nizatidine N-oxide, and nizatidine sulfoxide. Of these metabolites, only N-desmethylnizatidine has histamine H2-receptor blocking activity; studies in animals indicate that this metabolite is approximately 60% as active as nizatidine in blocking gastric acid secretion. Orally administered nizatidine undergoes minimal metabolism on first pass through the liver.

    McEvoy G.K. (ed.). American Hospital Formulary Service-Drug Information 96. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 1996 (Plus Supplements)., p. 2172

    5.7 Biological Half-Life

    1-2 hours

    Half life is 10 hours.

    American Medical Association, Council on Drugs. AMA Drug Evaluations Annual 1994. Chicago, IL: American Medical Association, 1994., p. 904

    5.8 Mechanism of Action

    Nizatidine competes with histamine for binding at the H2-receptors on the gastric basolateral membrane of parietal cells. Competitive inhibition results in reduction of basal and nocturnal gastric acid secretions. The drug also decreases the gastric acid response to stimuli such as food, caffeine, insulin, betazole, or pentagastrin.

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    10-Feb-2021
    17-Jan-2025
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    ABOUT THIS PAGE

    Looking for 76963-41-2 / Nizatidine API manufacturers, exporters & distributors?

    Nizatidine manufacturers, exporters & distributors 1

    24

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

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

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

    API | Excipient name

    Nizatidine

    Synonyms

    76963-41-2, Axid, Zanizal, Nizax, Ly-139037, Niaztidine

    Cas Number

    76963-41-2

    About Nizatidine

    A histamine H2 receptor antagonist with low toxicity that inhibits gastric acid secretion. The drug is used for the treatment of duodenal ulcers.

    Axid Manufacturers

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

    Axid Suppliers

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

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

    Axid USDMF

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

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

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

    Axid JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Axid Drug Master File in Japan (Axid JDMF) empowers Axid API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the Axid JDMF during the approval evaluation for pharmaceutical products. At the time of Axid JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of Axid suppliers with JDMF on PharmaCompass.

    Axid KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Axid Drug Master File in Korea (Axid KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Axid. The MFDS reviews the Axid KDMF as part of the drug registration process and uses the information provided in the Axid KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Axid KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Axid API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Axid suppliers with KDMF on PharmaCompass.

    Axid CEP

    A Axid CEP of the European Pharmacopoeia monograph is often referred to as a Axid Certificate of Suitability (COS). The purpose of a Axid CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Axid EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Axid to their clients by showing that a Axid CEP has been issued for it. The manufacturer submits a Axid CEP (COS) as part of the market authorization procedure, and it takes on the role of a Axid CEP holder for the record. Additionally, the data presented in the Axid CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Axid DMF.

    A Axid CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Axid CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

    click here to find a list of Axid suppliers with CEP (COS) on PharmaCompass.

    Axid WC

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

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

    Axid 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 Axid as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Axid GMP

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

    Axid CoA

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

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

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