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    Chemistry

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    Also known as: Clorazepic acid, Chlorazepate, 23887-31-2, 7-chloro-2,3-dihydro-2,2-dihydroxy-5-phenyl-1h-1,4-benzodiazepine-3-carboxylic acid, 7-chloro-2-oxo-5-phenyl-1,3-dihydro-1,4-benzodiazepine-3-carboxylic acid, 149128-44-9
    Molecular Formula
    C16H11ClN2O3
    Molecular Weight
    314.72  g/mol
    InChI Key
    XDDJGVMJFWAHJX-UHFFFAOYSA-N
    FDA UNII
    D51WO0G0L4
    Clorazepate Dipotassium
    A water-soluble benzodiazepine derivative effective in the treatment of anxiety. It has also muscle relaxant and anticonvulsant actions.
    Clorazepic acid is a Benzodiazepine.
    1 2D Structure

    Clorazepate Dipotassium

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    7-chloro-2-oxo-5-phenyl-1,3-dihydro-1,4-benzodiazepine-3-carboxylic acid
    2.1.2 InChI
    InChI=1S/C16H11ClN2O3/c17-10-6-7-12-11(8-10)13(9-4-2-1-3-5-9)19-14(16(21)22)15(20)18-12/h1-8,14H,(H,18,20)(H,21,22)
    2.1.3 InChI Key
    XDDJGVMJFWAHJX-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    C1=CC=C(C=C1)C2=NC(C(=O)NC3=C2C=C(C=C3)Cl)C(=O)O
    2.2 Other Identifiers
    2.2.1 UNII
    D51WO0G0L4
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 4306-cb

    2. Chlorazepate

    3. Clorazepate Dipotassium

    4. Clorazepate Monopotassium

    5. Clorazepic Acid

    6. Dipotassium Chlorazepate

    7. Tranxene

    8. Tranxilium

    2.3.2 Depositor-Supplied Synonyms

    1. Clorazepic Acid

    2. Chlorazepate

    3. 23887-31-2

    4. 7-chloro-2,3-dihydro-2,2-dihydroxy-5-phenyl-1h-1,4-benzodiazepine-3-carboxylic Acid

    5. 7-chloro-2-oxo-5-phenyl-1,3-dihydro-1,4-benzodiazepine-3-carboxylic Acid

    6. 149128-44-9

    7. 7-chloro-2-oxo-5-phenyl-2,3-dihydro-1h-1,4-benzodiazepine-3-carboxylic Acid

    8. 1h-1,4-benzodiazepine-3-carboxylic Acid, 7-chloro-2,3-dihydro-2-oxo-5-phenyl-

    9. 4306-cb Free Acid

    10. Chebi:3761

    11. D51wo0g0l4

    12. Abbott-35616 Free Acid

    13. Cchlorazepic Acid

    14. Clorazepic Acid [ban]

    15. Dea No. 2768

    16. 7-chloro-2,3-dihydro-2-oxo-5-phenyl-1h-1,4-benzodiazepine-3-carboxylic Acid

    17. Hsdb 3041

    18. 4306 Cb

    19. Einecs 245-926-8

    20. Unii-d51wo0g0l4

    21. Tranxene®

    22. (chloromethyl)(dimethyl)(tridecyloxy)silane

    23. Clorazepate [vandf]

    24. Clorazepic Acid [mi]

    25. Clorazepic Acid [hsdb]

    26. Gtpl7548

    27. Schembl1649064

    28. Chembl1213252

    29. Clorazepic Acid [mart.]

    30. Schembl21244066

    31. Clorazepic Acid [who-dd]

    32. Dtxsid20863674

    33. 23887-31-2 (free Acid)

    34. Db00628

    35. C06921

    36. Q418850

    37. 149128-42-7

    2.4 Create Date
    2005-03-25
    3 Chemical and Physical Properties
    Molecular Weight 314.72 g/mol
    Molecular Formula C16H11ClN2O3
    XLogP33.3
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count4
    Rotatable Bond Count2
    Exact Mass314.0458199 g/mol
    Monoisotopic Mass314.0458199 g/mol
    Topological Polar Surface Area78.8 Ų
    Heavy Atom Count22
    Formal Charge0
    Complexity488
    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 6  
    Drug NameClorazepate dipotassium
    PubMed HealthClorazepate (By mouth)
    Drug ClassesAntianxiety, Anticonvulsant
    Drug LabelThe compound occurs as a fine, light yellow, practically odorless powder. It is insoluble in the common organic solvents, but very soluble in water. Aqueous solutions are unstable, clear, light yellow, and alkaline.Clorazepate dipotassium tablets con...
    Active IngredientClorazepate dipotassium
    Dosage FormTablet
    RouteOral
    Strength3.75mg; 7.5mg; 15mg
    Market StatusPrescription
    CompanyRanbaxy; Taro; Mylan

    2 of 6  
    Drug NameGen-xene
    PubMed HealthClorazepate (By mouth)
    Drug ClassesAntianxiety, Anticonvulsant
    Drug LabelChemically, TRANXENE is a benzodiazepine. The empirical formula is C16H11ClK2N2O4; the molecular weight is 408.92; 1H-1, 4-Benzodiazepine-3-carboxylic acid, 7-chloro-2,3-dihydro-2-oxo-5-phenyl-, potassium salt compound with potassium hydroxide (1:1)...
    Active IngredientClorazepate dipotassium
    Dosage FormTablet
    RouteOral
    Strength7.5mg; 15mg; 3.75mg
    Market StatusPrescription
    CompanyAlra

    3 of 6  
    Drug NameTranxene
    Active IngredientClorazepate dipotassium
    Dosage FormTablet
    RouteOral
    Strength7.5mg; 15mg; 3.75mg
    Market StatusPrescription
    CompanyRecordati Rare

    4 of 6  
    Drug NameClorazepate dipotassium
    PubMed HealthClorazepate (By mouth)
    Drug ClassesAntianxiety, Anticonvulsant
    Drug LabelThe compound occurs as a fine, light yellow, practically odorless powder. It is insoluble in the common organic solvents, but very soluble in water. Aqueous solutions are unstable, clear, light yellow, and alkaline.Clorazepate dipotassium tablets con...
    Active IngredientClorazepate dipotassium
    Dosage FormTablet
    RouteOral
    Strength3.75mg; 7.5mg; 15mg
    Market StatusPrescription
    CompanyRanbaxy; Taro; Mylan

    5 of 6  
    Drug NameGen-xene
    PubMed HealthClorazepate (By mouth)
    Drug ClassesAntianxiety, Anticonvulsant
    Drug LabelChemically, TRANXENE is a benzodiazepine. The empirical formula is C16H11ClK2N2O4; the molecular weight is 408.92; 1H-1, 4-Benzodiazepine-3-carboxylic acid, 7-chloro-2,3-dihydro-2-oxo-5-phenyl-, potassium salt compound with potassium hydroxide (1:1)...
    Active IngredientClorazepate dipotassium
    Dosage FormTablet
    RouteOral
    Strength7.5mg; 15mg; 3.75mg
    Market StatusPrescription
    CompanyAlra

    6 of 6  
    Drug NameTranxene
    Active IngredientClorazepate dipotassium
    Dosage FormTablet
    RouteOral
    Strength7.5mg; 15mg; 3.75mg
    Market StatusPrescription
    CompanyRecordati Rare

    4.2 Therapeutic Uses

    FOR SYMPTOMATIC RELIEF OF ANXIETY ASSOCIATED WITH NEUROSIS, PSYCHONEUROSES WITH SYMPTOMS OF ANXIETY, & AS ADJUNCT IN DISEASE STATES IN WHICH ANXIETY IS PROMINENT FEATURE. /DIPOTASSIUM SALT/

    Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 1010

    RESULTS SUGGEST THAT CLORAZEPATE DIPOTASSIUM WHEN ADDED TO STD REGIMEN IN LOW DOSES, IS USEFUL IN TREATMENT OF INTRACTABLE MINOR SEIZURES. /CLORAZEPATE DIPOTASSIUM/

    BOOKER HE; J AM MED ASSOC 229 (JUL): 552-5 (1974)

    RESULTS SHOWED NO DIFFERENCE BETWEEN THE TWO & RESPONSE DID NOT DIFFER ACCORDING TO TYPE OF ANXIETY--PSYCHOLOGICAL OR SOMATIC. /FROM ABSTRACT/

    PMID:23489 BURROW ET AL; MED J AUST 2 (OCT): 525-8 (1977)

    Management of alcohol withdrawal /Clorazepate dipotassium from table/

    Gilman, A.G., T.W. Rall, A.S. Nies and P. Taylor (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 8th ed. New York, NY. Pergamon Press, 1990., p. 357

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

    4.3 Drug Warning

    THIS DRUG SHOULD NOT BE DISCONTINUED ABRUPTLY, ALTHOUGH NO SERIOUS ADVERSE EFFECTS WERE OBSERVED UPON ABRUPT DISCONTINUATION OF 6 WK COURSE OF 120 MG DAILY. LONG-TERM THERAPY WITH LARGER THAN USUAL DOSES MAY RESULT IN PSYCHIC & PHYSICAL DEPENDENCE. /CLORAZEPATE DIPOTASSIUM SALT/

    American Medical Association, AMA Department of Drugs, AMA Drug Evaluations. 3rd ed. Littleton, Massachusetts: PSG Publishing Co., Inc., 1977., p. 414

    CLORAZEPATE POTASSIUM REQUIRES SAME WARNINGS & PRECAUTIONS REGARDING USE WITH OTHER DRUGS, USE IN HYPERSENSITIVE INDIVIDUALS, USE DURING PREGNANCY & IN YOUNG CHILDREN, USE IN ELDERLY & EXCESSIVELY DEPRESSED PATIENT ... AS WITH OTHER BENZODIAZEPINES ... . /CLORAZEPATE DIPOTASSIUM/

    Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 1010

    CLORAZEPATE POTASSIUM REQUIRES ... PRECAUTIONS ... IN PATIENT WITH IMPAIRED RENAL OR HEPATIC FUNCTION, & USE IN PATIENT WITH HISTORY OF DRUG ADDICTION AS WITH OTHER BENZODIAZEPINES ... . /CLORAZEPATE DIPOTASSIUM/

    Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 1010

    PATIENTS RECEIVING ANY BENZODIAZEPINE CMPD SHOULD BE WARNED TO AVOID ALCOHOL, SINCE CONCURRENT INGESTION COULD RESULT IN AN IMPAIRMENT OF THEIR ABILITY TO DRIVE AUTOMOBILE OR OPERATE HAZARDOUS MACHINERY. /BENZODIAZEPINE CMPD/

    Evaluations of Drug Interactions. 2nd ed. and supplements. Washington, DC: American Pharmaceutical Assn., 1976, 1978., p. 47

    For more Drug Warnings (Complete) data for CLORAZEPATE (10 total), please visit the HSDB record page.

    4.4 Drug Indication

    For the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Also used as adjunctive therapy in the management of partial seizures and for the symptomatic relief of acute alcohol withdrawal.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Clorazepate is a member of the group of drugs called benzodiazepines. Pharmacologically, clorazepate has the characteristics of the benzodiazepines. It has depressant effects on the central nervous system. The primary metabolite, nordiazepam, quickly appears in the blood stream. Studies in healthy men have shown that clorazenate has depressant effects on the central nervous system. Since orally administered clorazepate dipotassium is rapidly decarboxylated to form nordiazepam, there is essentially no circulating parent drug.

    5.2 MeSH Pharmacological Classification

    Anticonvulsants

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

    GABA Modulators

    Substances that do not act as agonists or antagonists but do affect the GAMMA-AMINOBUTYRIC ACID receptor-ionophore complex. GABA-A receptors (RECEPTORS, GABA-A) appear to have at least three allosteric sites at which modulators act: a site at which BENZODIAZEPINES act by increasing the opening frequency of GAMMA-AMINOBUTYRIC ACID-activated chloride channels; a site at which BARBITURATES act to prolong the duration of channel opening; and a site at which some steroids may act. GENERAL ANESTHETICS probably act at least partly by potentiating GABAergic responses, but they are not included here. (See all compounds classified as GABA Modulators.)

    Anti-Anxiety Agents

    Agents that alleviate ANXIETY, tension, and ANXIETY DISORDERS, promote sedation, and have a calming effect without affecting clarity of consciousness or neurologic conditions. ADRENERGIC BETA-ANTAGONISTS are commonly used in the symptomatic treatment of anxiety but are not included here. (See all compounds classified as Anti-Anxiety Agents.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    CLORAZEPIC ACID
    5.3.2 FDA UNII
    D51WO0G0L4
    5.3.3 Pharmacological Classes
    Chemical Structure [CS] - Benzodiazepines
    5.4 Absorption, Distribution and Excretion

    Absorption

    Rapidly absorbed following oral administration (bioavailability is 91%).

    Route of Elimination

    The drug is metabolized in the liver and excreted primarily in the urine.

    PRIMARY METABOLITE, NORDIAZEPAM, REACHES PEAK LEVELS IN PLASMA IN 1 HR; PLASMA HALF-LIFE IS ABOUT 24 HR.

    Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 1010

    PLASMA HALF-LIFE ELIMINATION COEF, CONCN, & APPARENT VOL OF DISTRIBUTION CALCULATED & MEAN VALUES WERE 53 HR, 0.0147 HR-1, 884 NG/ML, & 1.13 L/KG.

    POST ET AL; PSYCHOPHARMACOLOGY (BERLIN) 53 (2): 105-9 (1977)

    TIME REQUIRED TO REACH PEAK SERUM CONCN OF N-DIMETHYLDIAZEPAM, METABOLITE OF CHLORAZEPATE, WAS 80 MIN. MEAN HALF-LIFE 62 HR. DATA FOR OTHERS GIVEN.

    WRETLIND M ET AL; ACTA PHARMACOL TOXICOL, SUPPL 40 (1): 28-39 (1977)

    WHEN ADMIN IM, CLORAZEPATE WAS RAPIDLY ABSORBED & PEAK CONCN REACHED IN 2 HR. ABSORPTION HALF-LIFE WAS 0.77 HR IN PREGNANT WOMEN & 0.56 HR IN NONPREGNANT WOMEN.

    PMID:37089 REY ET AL; EUR J CLIN PHARMACOL 15 (3): 175-80 (1979)

    For more Absorption, Distribution and Excretion (Complete) data for CLORAZEPATE (12 total), please visit the HSDB record page.

    5.5 Metabolism/Metabolites

    The drug is metabolized in the liver and excreted primarily in the urine. The primary metabolite, nordiazepam, is further metabolized by hydroxylation. The major urinary metabolite is conjugated oxazepam (3-hydroxynordiazepam), and smaller amounts of conjugated p-hydroxynordiazepam and nordiazepam are also found in the urine.

    CHLORAZEPATE IS PROBABLY CONVERTED TO N-DIMETHYL DIAZEPAM, WHICH IS THEN OXIDIZED TO OXAZEPAM. /CHLORAZEPATE/

    Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 189

    PRIMARY METABOLITE /IS/ NORDIAZEPAM ... .

    Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 1010

    Following oral administration of clorazepate dipotassium, it appears that most of the drug is rapidly decarboxylated in the GI tract and is absorbed as desmethyldiazepam (nordiazepam). The rate of decarboxylation of clorazepate decreases as gastric pH increases. /Clorazepate dipotassium/

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 92. Bethesda, MD: American Society of Hospital Pharmacists, Inc., 1992 (Plus Supplements 1992)., p. 1331

    Clorazepate active metabolites in liver are desmethyldiazepam, and oxazepam; active substances in blood include desmethyldiazepam. /From table/

    Ellenhorn, M.J. and D.G. Barceloux. Medical Toxicology - Diagnosis and Treatment of Human Poisoning. New York, NY: Elsevier Science Publishing Co., Inc. 1988., p. 582

    For more Metabolism/Metabolites (Complete) data for CLORAZEPATE (8 total), please visit the HSDB record page.

    5.6 Biological Half-Life

    The serum half-life is about 2 days. Nordiazepam, the primary metabolite, quickly appears in the blood and is eliminated from the plasma with an apparent half-life of about 40 to 50 hours.

    PLASMA HALF-LIFE ... 53 HR ... .

    POST ET AL; PSYCHOPHARMACOLOGY (BERLIN) 53 (2): 105-9 (1977)

    PRIMARY METABOLITE, NORDIAZEPAM, ... PLASMA HALF-LIFE IS ABOUT 24 HR.

    Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 1010

    N-DIMETHYLDIAZEPAM, METABOLITE OF CHLORAZEPATE: MEAN HALF-LIFE 62 HR.

    WRETLIND M ET AL; ACTA PHARMACOL TOXICOL, SUPPL 40 (1): 28-39 (1977)

    CLORAZEPATE ADMIN IM TO PREGNANT & NONPREGNANT WOMEN. ELIMINATION HALF-LIFE WERE 1.3 HR IN PREGNANT WOMEN & 2.0 HR IN NONPREGNANT WOMEN. ITS METABOLITE, NORDIAZEPAM, REACHED PEAK CONCN WITHIN 12 HR. HALF-LIFE OF ELIMINATION FOR METABOLITE WAS 180 IN PREGNANT & 60 HR IN NONPREGNANT WOMEN.

    PMID:37089 REY ET AL; EUR J CLIN PHARMACOL 15 (3): 175-80 (1979)

    Elimination half-lives for metabolites: desmethyldiazepam (30-200 hr) and oxazepam (3-21 hr)

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 92. Bethesda, MD: American Society of Hospital Pharmacists, Inc., 1992 (Plus Supplements 1992)., p. 1331

    5.7 Mechanism of Action

    Benzodiazepines bind nonspecifically to benzodiazepine receptors BNZ1, which mediates sleep, and BNZ2, which affects affects muscle relaxation, anticonvulsant activity, motor coordination, and memory. As benzodiazepine receptors are thought to be coupled to gamma-aminobutyric acid-A (GABAA) receptors, this enhances the effects of GABA by increasing GABA affinity for the GABA receptor. Binding of the inhibitory neurotransmitter GABA to the site opens the chloride channel, resulting in a hyperpolarized cell membrane that prevents further excitation of the cell.

    The effects of benzodiazepines on the waking EEG resemble those of other sedative-hypnotic drugs. Alpha activity is decreased, and there is an increase in low-voltage fast activity, especially beta activity. /Benzodiazepines/

    Gilman, A.G., T.W. Rall, A.S. Nies and P. Taylor (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 8th ed. New York, NY. Pergamon Press, 1990., p. 349

    Acticonvulsant actions of the benzodiazepines, as well as other effects that occur at nonsedating doses, result in large part from their ability to enhance GABA-induced increases in the conductance of chloride. /Benzodiazepines/

    Gilman, A.G., T.W. Rall, A.S. Nies and P. Taylor (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 8th ed. New York, NY. Pergamon Press, 1990., p. 454

    Benzodiazepines appear to produce their sedative, hypnotic, anxiolytic, and anticonvulsant actions by binding to specific pharmacologic receptors in the central nervous system. Benzodiazepine receptors are most concentrated in the cerebral cortex but are also found in the cerebellum, amygdala, hippocampus, hypothalamus, and spinal cord. Receptors have also been identified outside CNS, although peripheral receptors do not appear to have significant physiologic effects. The molecular receptor for the benzodiazepine molecule is a glycoprotein located on the lipid membranes of both neural and glial cells. It is speculated that there are at least two classes of benzodiazepine receptor believed to mediate different specific effects. Type I receptors predominate in the cerebelar cortex, and both type I and type II receptors are found in the cerebral cortex and hippocampus. Type I rceptors are postulated to mediate anxiolytic effects, and type II receptors mediate the sedative and other actions of benzodiazepines. No endogenous ligand or neurotransmitter for these receptors has been identified. /Benzodiazepines/

    Haddad, L.M., Clinical Management of Poisoning and Drug Overdose. 2nd ed. Philadelphia, PA: W.B. Saunders Co., 1990., p. 806

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    NDC Package Code : 69037-0067

    Start Marketing Date : 1982-01-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

     KDMF VMF Others AUDIT
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    04

    Taro Pharmaceutical Industries

    U.S.A

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Taro Pharmaceutical Industries

    U.S.A

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 14169

    Submission : 1999-06-02

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2009-386 - Rev 01

    Issue Date : 2020-06-22

    Type : Chemical

    Substance Number : 898

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Not Available For Sales AUDIT
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    05

    Cambrex Corporation

    U.S.A

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Cambrex Corporation

    U.S.A

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2018-09-27

    Pay. Date : 2018-09-21

    DMF Number : 4240

    Submission : 1981-06-26

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 219MF10063

    Registrant's Address : Via Curiel 34, 20067 Paulo, Milano, ITALY

    Initial Date of Registration : 2007-03-05

    Latest Date of Registration : --

     EU-WC NDC arrow-down
    ✖

    NDC Package Code : 12828-0019

    Start Marketing Date : 1987-03-26

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

     KDMF VMF Others AUDIT
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    06

    RANBAXY LABORATORIES LIMITED

    India

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    RANBAXY LABORATORIES LIMITED

    India

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16980

    Submission : 2003-11-25

    Status : Inactive

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    07

    F.I.S. Fabbrica Italiana Sintetici

    Italy

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    F.I.S. Fabbrica Italiana Sintetici

    Italy

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 5922

    Submission : 1985-07-24

    Status : Inactive

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    08

    Industriale Chimica

    Italy

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Industriale Chimica

    Italy

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 3978

    Submission : 1980-11-04

    Status : Inactive

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    Digital Content

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    09

    R L Fine Chem

    India

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    R L Fine Chem

    India

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    blank

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    Product Web Link

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    Digital Content

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    10

    Hoventa Pharma

    India

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Hoventa Pharma

    India

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    USDMF

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    01

    Sanofi Sa

    France
    arrow
    Pharmatech Expo 2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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    Digital Content Digital Content

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 4252

    Submission : 1981-08-10

    Status : Inactive

    Type : II

    Sanofi Company Banner

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    02

    Pharmatech Expo 2025
    Not Confirmed

    02

    Cambrex Profarmaco Milano Srl

    U.S.A
    arrow
    Pharmatech Expo 2025
    Not Confirmed

    GDUFA

    DMF Review : Complete

    Rev. Date : 2018-09-27

    Pay. Date : 2018-09-21

    DMF Number : 4240

    Submission : 1981-06-26

    Status : Active

    Type : II

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    03

    Pharmatech Expo 2025
    Not Confirmed

    03

    Fabbrica Italiana Sintetici Spa

    Italy
    arrow
    Pharmatech Expo 2025
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 5922

    Submission : 1985-07-24

    Status : Inactive

    Type : II

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    04

    Honour Lab Ltd

    India

    USDMF

    arrow
    Pharmatech Expo 2025
    Not Confirmed

    04

    Honour Lab Ltd

    India
    arrow
    Pharmatech Expo 2025
    Not Confirmed

    GDUFA

    DMF Review : Complete

    Rev. Date : 2023-02-14

    Pay. Date : 2023-01-23

    DMF Number : 37475

    Submission : 2022-09-20

    Status : Active

    Type : II

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    05

    Pharmatech Expo 2025
    Not Confirmed

    05

    Industria Chimica Profarmaco Spa

    Italy
    arrow
    Pharmatech Expo 2025
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 3978

    Submission : 1980-11-04

    Status : Inactive

    Type : II

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    06

    Pharmatech Expo 2025
    Not Confirmed

    06

    Sun Pharmaceutical Industries Ltd

    India
    arrow
    Pharmatech Expo 2025
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16980

    Submission : 2003-11-25

    Status : Inactive

    Type : II

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    07

    Pharmatech Expo 2025
    Not Confirmed

    07

    Taro Pharmaceutical Industries Ltd

    U.S.A
    arrow
    Pharmatech Expo 2025
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 14169

    Submission : 1999-06-02

    Status : Active

    Type : II

    blank

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    CEP/COS

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    SANOFI WINTHROP INDUSTRIE Gentilly ...

    Contact Supplier
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    • EDQM
    • WHO-GMP
    • fda
    • EDQM
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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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    Flag France
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Dipotassium clorazepate monohydrate

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    CEP 2008-170 - Rev 02
    Valid
    Chemical
    2024-03-28
    898
    Sanofi Company Banner

    01

    SANOFI WINTHROP INDUSTRIE Gentilly ...

    France
    arrow
    Pharmatech Expo 2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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    Flag France
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    Digital Content Digital Content

    Dipotassium Clorazepate Monohydrate

    Certificate Number : CEP 2008-170 - Rev 02

    Status : Valid

    Issue Date : 2024-03-28

    Type : Chemical

    Substance Number : 898

    Sanofi Company Banner

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    TARO PHARMACEUTICAL INDUSTRIES, LTD...

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    • EDQM
    • fda
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    Dipotassium clorazepate monohydrate

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    R1-CEP 2009-386 - Rev 01
    Valid
    Chemical
    2020-06-22
    898
    blank

    02

    TARO PHARMACEUTICAL INDUSTRIES, LTD...

    U.S.A
    Pharmatech Expo 2025
    Not Confirmed
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    NDC API

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    01

    NURAY CHEMICALS PRIVATE LIMITED

    India
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    Pharmatech Expo 2025
    Not Confirmed
    • 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.

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    Digital Content Digital Content

    CLORAZEPATE DIPOTASSIUM

    NDC Package Code : 58159-097

    Start Marketing Date : 2023-06-09

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (35kg/35kg)

    Marketing Category : BULK INGREDIENT

    Nuray Chemicals

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    02

    Cambrex Profarmaco Milano Srl

    U.S.A
    Pharmatech Expo 2025
    Not Confirmed
    arrow

    Cambrex Profarmaco Milano Srl

    U.S.A
    arrow
    Pharmatech Expo 2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    CLORAZEPATE DIPOTASSIUM

    NDC Package Code : 12828-0019

    Start Marketing Date : 1987-03-26

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    03

    Honour Lab Limited

    India
    Pharmatech Expo 2025
    Not Confirmed
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    Honour Lab Limited

    India
    arrow
    Pharmatech Expo 2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Digital Content Digital Content

    CLORAZEPATE DIPOTASSIUM

    NDC Package Code : 69037-0067

    Start Marketing Date : 1982-01-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    Listed Suppliers

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    01

    Nuray Chemicals Private Limited

    India
    arrow
    Pharmatech Expo 2025
    Not Confirmed
    • 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.

    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Clorazepate Dipotassium

    About the Company : Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in th...

    Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in the Indian state of Tamil Nadu. Nuray’s expertise and experience lie in developing the chemistry requirements of the pharmaceutical industry, including the synthesis of NCEs, impurities, metabolites, method development, advanced intermediates and APIs for commercial launch. With its focus on maintaining the highest levels of quality, reliability and transparency, Nuray has emerged as a trusted partner in the global generic market.
    Nuray Chemicals

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    02

    Cambrex Corporation

    U.S.A
    Pharmatech Expo 2025
    Not Confirmed
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    Cambrex Corporation

    U.S.A
    arrow
    Pharmatech Expo 2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Flag U.S.A
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Clorazepate Dipotassium

    About the Company : Driven by passion, our pharmaceutical products, expertise and technologies accelerate our customers’ small molecule therapeutics into markets across the world. With over 35 years...

    Driven by passion, our pharmaceutical products, expertise and technologies accelerate our customers’ small molecule therapeutics into markets across the world. With over 35 years of API development and manufacturing expertise, a growing team of more than 1,200 experts and a strong presence in the USA and Europe, we are tried and trusted across branded and generic API markets. We put all of our energy and experience into being your partner of choice. We create value for customers through manufacturing excellence, reliable quality and innovative science. Our people are the experts that our customers enjoy working with.
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    03

    Hetero Drugs

    India
    Pharmatech Expo 2025
    Not Confirmed
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    Hetero Drugs

    India
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    Clorazepate Dipotassium

    About the Company : Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & F...

    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.
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    04

    Hoventa Pharma

    India
    Pharmatech Expo 2025
    Not Confirmed
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    Hoventa Pharma

    India
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    Clorazepate Dipotassium

    About the Company : Hoventa Pharma is in the business of manufacturing APIs for over three decades.We offer various kinds of services in addition to supplies of APIs, we undertake long-term contracts ...

    Hoventa Pharma is in the business of manufacturing APIs for over three decades.We offer various kinds of services in addition to supplies of APIs, we undertake long-term contracts for manufacturing intermediates and development of new Active Pharmaceutical Ingredients as per your requirement. We have a sharp focus on giving value added services to our customers cost effectively. We are supplying APIs to the global pharmaceutical companies in India and abroad since the last 3 decades. Some of our major customers operate in India and export to their products to other countries.
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    05

    R L Fine Chem

    India
    Pharmatech Expo 2025
    Not Confirmed
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    R L Fine Chem

    India
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    Clorazepate Dipotassium

    About the Company : Established in 1984, R L Fine Chem Pvt. Ltd. is one of the fastest growing API companies, with a leadership position in several APIs such as antihistamines, antidepressants and mus...

    Established in 1984, R L Fine Chem Pvt. Ltd. is one of the fastest growing API companies, with a leadership position in several APIs such as antihistamines, antidepressants and muscle relaxants. Acquired by private equity groups in 2016, it is one of India’s leading manufacturers of psychotropic substances. It supplies over 60 APIs to customers in more than 62 countries from FDA and EU-approved locations. R L Fine Chem is a technology-driven company with a focus on the in-house manufacture of key intermediates for our APIs. The company currently operates out of four facilities in the Indian states of Karnataka and Andhra Pradesh.
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    API Reference Price

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    [{"dataSource":"API Import","activeIngredients":"CLORAZEPATE DIPOTASSIUM","year":"2021","qtr":"Q2","strtotime":1619980200,"product":"CLORAZEPATE DIPOTASSIUM","address":"304,ATLANTA ARCADE,MAROL CHURCH RD,ANDHERI(E)","city":"MUMBAI","supplier":"CAMBREX CORPORATION","supplierCountry":"ITALY","foreign_port":"MILAN","customer":"MACLEODS PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"0.50","actualQuantity":"0.5","unit":"KGS","unitRateFc":"6500","totalValueFC":"4070.9","currency":"EUR","unitRateINR":"596375","date":"03-May-2021","totalValueINR":"298187.5","totalValueInUsd":"4070.9","indian_port":"BOMBAY AIR","hs_no":"29339990","bill_no":"3796398","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN","supplierAddress":"","customerAddress":"304,ATLANTA ARCADE,MAROL CHURCH RD,ANDHERI(E)"},{"dataSource":"API Import","activeIngredients":"CLORAZEPATE DIPOTASSIUM","year":"2021","qtr":"Q2","strtotime":1621276200,"product":"CLORAZEPATE DIPOTASSIUM USP","address":"PLOT NO.2, MAITRIVIHAR,BEHIND MAITRIVANAM, AMEERPET,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"AUROBINDO PHARMA LIMITED","supplierCountry":"UNITED STATES","foreign_port":"NEW YORK - JOHN F. K","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"3.50","actualQuantity":"3.5","unit":"KGS","unitRateFc":"4000","totalValueFC":"14286.8","currency":"USD","unitRateINR":"299000","date":"18-May-2021","totalValueINR":"1046500","totalValueInUsd":"14286.8","indian_port":"HYDERABAD AIR","hs_no":"29339100","bill_no":"3991097","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NEW YORK - JOHN F. K","supplierAddress":"","customerAddress":"PLOT NO.2, MAITRIVIHAR,BEHIND MAITRIVANAM, AMEERPET,"}]
    03-May-2021
    18-May-2021
    KGS
    overview
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    Average Price (USD/KGS)

    Number of Transactions

    Total Quantity (KGS)

    Total Value (USD)

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

    API Imports and Exports

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

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    INTERMEDIATES SUPPLIERS

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    01

    Acharya Chemicals

    India
    Pharmatech Expo 2025
    Not Confirmed
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    Acharya Chemicals

    India
    Pharmatech Expo 2025
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    2-Amino-5-chlorobenzonitrile

    CAS Number : 5922-60-1

    End Use API : Clorazepate Dipotassium

    About The Company : Established in 1975, Acharya Group is a trusted and well-established chemical manufacturing company renowned for its commitment to technological excellence. Ach...

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    DOSAGE - TABLET;ORAL - 11.25MG **Federal Regi...DOSAGE - TABLET;ORAL - 11.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 17105

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    DOSAGE - CAPSULE;ORAL - 15MG **Federal Regist...DOSAGE - CAPSULE;ORAL - 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 17105

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    DOSAGE - TABLET;ORAL - 22.5MG **Federal Regis...DOSAGE - TABLET;ORAL - 22.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 17105

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    DOSAGE - CAPSULE;ORAL - 3.75MG **Federal Regi...DOSAGE - CAPSULE;ORAL - 3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 17105

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    DOSAGE - CAPSULE;ORAL - 7.5MG **Federal Regis...DOSAGE - CAPSULE;ORAL - 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 17105

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    ABOUT THIS PAGE

    Clorazepate Dipotassium Manufacturers

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

    Clorazepate Dipotassium Suppliers

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

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

    Clorazepate Dipotassium USDMF

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

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

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

    Clorazepate Dipotassium 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 Clorazepate Dipotassium Drug Master File in Japan (Clorazepate Dipotassium JDMF) empowers Clorazepate Dipotassium 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 Clorazepate Dipotassium JDMF during the approval evaluation for pharmaceutical products. At the time of Clorazepate Dipotassium 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 Clorazepate Dipotassium suppliers with JDMF on PharmaCompass.

    Clorazepate Dipotassium CEP

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

    A Clorazepate Dipotassium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Clorazepate Dipotassium 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 Clorazepate Dipotassium suppliers with CEP (COS) on PharmaCompass.

    Clorazepate Dipotassium 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 Clorazepate Dipotassium as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Clorazepate Dipotassium GMP

    Clorazepate Dipotassium 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 Clorazepate Dipotassium 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 Clorazepate Dipotassium GMP manufacturer or Clorazepate Dipotassium GMP API supplier for your needs.

    Clorazepate Dipotassium CoA

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

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

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