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    Chemistry

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    Also known as: 304-20-1, 1-hydrazinophthalazine hydrochloride, Hydralazine hcl, Apresoline, 1-hydrazinylphthalazine hydrochloride, Aiselazine
    Molecular Formula
    C8H9ClN4
    Molecular Weight
    196.64  g/mol
    InChI Key
    ZUXNZUWOTSUBMN-UHFFFAOYSA-N
    FDA UNII
    FD171B778Y
    Hydralazine Hydrochloride
    A direct-acting vasodilator that is used as an antihypertensive agent.
    1 2D Structure

    Hydralazine Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    phthalazin-1-ylhydrazine;hydrochloride
    2.1.2 InChI
    InChI=1S/C8H8N4.ClH/c9-11-8-7-4-2-1-3-6(7)5-10-12-8;/h1-5H,9H2,(H,11,12);1H
    2.1.3 InChI Key
    ZUXNZUWOTSUBMN-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    C1=CC=C2C(=C1)C=NN=C2NN.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    FD171B778Y
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Apresoline

    2. Apressin

    3. Apressoline

    4. Hydralazine

    5. Hydralazine Mono Hydrochloride

    6. Hydralazine Mono-hydrochloride

    7. Hydrallazin

    8. Hydrazinophthalazine

    9. Hydrochloride, Hydralazine

    10. Mono-hydrochloride, Hydralazine

    11. Nepresol

    2.3.2 Depositor-Supplied Synonyms

    1. 304-20-1

    2. 1-hydrazinophthalazine Hydrochloride

    3. Hydralazine Hcl

    4. Apresoline

    5. 1-hydrazinylphthalazine Hydrochloride

    6. Aiselazine

    7. Dralzine

    8. Hydralazine Chloride

    9. Hyperazin

    10. Hyperex

    11. Lopress

    12. Slow-apresolin

    13. Hydralazine Monohydrochloride

    14. Apresoline Hydrochloride

    15. 1-hydrazinophthalazine Monohydrochloride

    16. Hydralazine (hydrochloride)

    17. 1(2h)-phthalazinone, Hydrazone, Monohydrochloride

    18. Phthalazin-1-ylhydrazine;hydrochloride

    19. Praparat 5968

    20. Nsc-89394

    21. Phthalazine, 1-hydrazino-, Monohydrochloride

    22. Chebi:31672

    23. Fd171b778y

    24. Mc-1101

    25. Apresine

    26. Rolazine

    27. Apresoline-esidrix

    28. Dsstox_cid_24645

    29. Dsstox_rid_80373

    30. Dsstox_gsid_44645

    31. Phthalazine, 1-hydrazinyl-, Hydrochloride (1:1)

    32. 1044569-46-1

    33. Nor-press 25

    34. Hydrallazine Hydrochloride

    35. Ccris 334

    36. Hsdb 434

    37. Hydralazine Hydrochloride [jan]

    38. Sr-01000075903

    39. Ncgc00015501-02

    40. 1(2h)-phthalazinone, Hydrazone, Hydrochloride

    41. Cas-304-20-1

    42. Einecs 206-151-0

    43. Nsc 89394

    44. Apressinum

    45. Phthalazinone, Hydrazone, Monohydrochloride

    46. Unii-fd171b778y

    47. Apresoline (tn)

    48. Prestwick_610

    49. Hydralazine Hydrochloride [usp:jan]

    50. Hydralazinhydrochlorid

    51. Mfcd00135998

    52. 1-hydrazinyl-phthalazine Hydrochloride

    53. Ophthazin Impurity 2

    54. Hydralazinehydrochloride

    55. Hydralazini Hydrochloridum

    56. 1-hydrazinophthalazine Hcl

    57. Apressinum [who-ip]

    58. Schembl36271

    59. Phthalazine, Monohydrochloride

    60. Spectrum1500334

    61. Chembl542541

    62. Phthalazinone, Monohydrochloride

    63. Dtxsid1044645

    64. Bpi-103

    65. Pra 027

    66. Hms1568b19

    67. Hms1920d17

    68. Pharmakon1600-01500334

    69. Hy-b0464

    70. Nsc89394

    71. Wln: T66 Cnnj Bmz & Gh

    72. 1(2h)-phthalazinone, Hydrochloride

    73. Tox21_110163

    74. Tox21_302496

    75. Tox21_500593

    76. Ccg-40185

    77. Nsc757058

    78. S2562

    79. 1-hydrazinophthalazinemonohydrochloride

    80. Hydralazine Hydrochloride [mi]

    81. Akos008968535

    82. Akos025116605

    83. Akos028109609

    84. Hydralazine Hydrochloride (jp17/usp)

    85. Tox21_110163_1

    86. 1(2h)-phthalazinone, Monohydrochloride

    87. Ccg-266561

    88. Lp00593

    89. Nsc-757058

    90. Hydralazine Hydrochloride [hsdb]

    91. Phthalazinone Hydrazone Monohydrochloride

    92. Hydralazine Hydrochloride [mart.]

    93. Hydralazine Hydrochloride [vandf]

    94. Ncgc00015501-09

    95. Ncgc00093972-01

    96. Ncgc00093972-02

    97. Ncgc00093972-03

    98. Ncgc00093972-04

    99. Ncgc00256719-01

    100. Ncgc00261278-01

    101. Ac-18050

    102. Hydralazine Hydrochloride [usp-rs]

    103. Hydralazine Hydrochloride [who-dd]

    104. Hydralazine Hydrochloride [who-ip]

    105. 1(2h)-phthalazinone Hydrazone Hydrochloride

    106. Eu-0100593

    107. Ft-0669283

    108. H0409

    109. En300-03637

    110. Bidil Component Hydralazine Hydrochloride

    111. D01302

    112. H 1753

    113. Hydralazine Hydrochloride [orange Book]

    114. Hydralazine Hydrochloride [usp Impurity]

    115. Hydralazine Hydrochloride [usp Monograph]

    116. Hydralazini Hydrochloridum [who-ip Latin]

    117. A820366

    118. Dralserp Component Hydralazine Hydrochloride

    119. Hydralazine Hydrochloride Component Of Bidil

    120. Unipres Component Hydralazine Hydrochloride

    121. Apresazide Component Hydralazine Hydrochloride

    122. Cam-ap-es Component Hydralazine Hydrochloride

    123. Hydrap-es Component Hydralazine Hydrochloride

    124. Q-201208

    125. Ser-a-gen Component Hydralazine Hydrochloride

    126. Ser-ap-es Component Hydralazine Hydrochloride

    127. Sr-01000075903-1

    128. Sr-01000075903-5

    129. (z)-1-hydrazono-1,2-dihydrophthalazine Hydrochloride

    130. Hydra-zide Component Hydralazine Hydrochloride

    131. Hydralazine Hydrochloride Component Of Dralserp

    132. Hydralazine Hydrochloride Component Of Unipres

    133. Q27114606

    134. Z57980178

    135. Hydralazine Hydrochloride Component Of Apresazide

    136. Hydralazine Hydrochloride Component Of Cam-ap-es

    137. Hydralazine Hydrochloride Component Of Hydra-zide

    138. Hydralazine Hydrochloride Component Of Hydrap-es

    139. Hydralazine Hydrochloride Component Of Ser-a-gen

    140. Hydralazine Hydrochloride Component Of Ser-ap-es

    141. Apresoline-esidrix Component Hydralazine Hydrochloride

    142. Hydralazine Hydrochloride Component Of Apresoline-esidrix

    143. Serpasil-apresoline Component Hydralazine Hydrochloride

    144. Hydralazine Hydrochloride Component Of Serpasil-apresoline

    145. Hydroserpine Plus (r-h-h) Component Hydralazine Hydrochloride

    146. Hydralazine Hydrochloride Component Of Hydroserpine Plus (r-h-h)

    147. Hydralazine Hydrochloride Component Of Hydralazine Hydrochloride-hydrochlorothiazide-reserpine

    148. Hydralazine Hydrochloride-hydrochlorothiazide-reserpine Component Hydralazine Hydrochloride

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 196.64 g/mol
    Molecular Formula C8H9ClN4
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count4
    Rotatable Bond Count1
    Exact Mass196.0515740 g/mol
    Monoisotopic Mass196.0515740 g/mol
    Topological Polar Surface Area63.8 Ų
    Heavy Atom Count13
    Formal Charge0
    Complexity150
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameHydralazine hydrochloride
    Drug LabelHydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is:C8H8N4HClHydrALAZINE hydrochloride, USP is a white to off-white, odorless cr...
    Active IngredientHydralazine hydrochloride
    Dosage FormTablet; Injectable
    RouteInjection; Oral
    Strength20mg/ml; 25mg; 100mg; 50mg; 10mg
    Market StatusPrescription
    CompanyNavinta; Glenmark Pharms; Cadila Pharms; Alkem Labs; Hetero Labs Ltd Iii; Invagen Pharms; Par Pharm; Actavis Grp Ptc; Strides Pharma; Fresenius Kabi Usa; Luitpold; Pliva; Mylan; Heritage Pharms; Akorn

    2 of 2  
    Drug NameHydralazine hydrochloride
    Drug LabelHydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is:C8H8N4HClHydrALAZINE hydrochloride, USP is a white to off-white, odorless cr...
    Active IngredientHydralazine hydrochloride
    Dosage FormTablet; Injectable
    RouteInjection; Oral
    Strength20mg/ml; 25mg; 100mg; 50mg; 10mg
    Market StatusPrescription
    CompanyNavinta; Glenmark Pharms; Cadila Pharms; Alkem Labs; Hetero Labs Ltd Iii; Invagen Pharms; Par Pharm; Actavis Grp Ptc; Strides Pharma; Fresenius Kabi Usa; Luitpold; Pliva; Mylan; Heritage Pharms; Akorn

    4.2 Therapeutic Uses

    Antihypertensive Agents; Vasodilator Agents

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

    MEDICATION (VET): Use in exptl medicine and surgery. Use in dogs with hydrocortisone in hemorrhagic Shock or endotoxic shock markedly promoted survival. Increases renal blood flow.

    Rossoff, I.S. Handbook of Veterinary Drugs. New York: Springer Publishing Company, 1974., p. 263

    Hydralazine is indicated orally in the treatment of hypertension. Hydralazine is indicated intravenously when oral therapy cannot be given or when there is an urgent need to lower blood pressure, such as in hypertensive crisis or pre-eclampsia or eclampsia. /Included in US product labeling/

    MICROMEDEX Thomson Health Care. USPDI - Drug Information for the Health Care Professional. 22nd ed. Volume 1. MICROMEDEX Thomson Health Care, Greenwood Village, CO. 2002. Content Reviewed and Approved by the U.S. Pharmacopeial Convention, Inc., p. 1661

    Hydralazine combined with isosorbide dinitrate (nonspecific vasodilator therapy) has been used as a supplement to the traditional congestive heart failure treatment of digitalis and diuretics. /NOT included in US or Canadian product labeling/

    MICROMEDEX Thomson Health Care. USPDI - Drug Information for the Health Care Professional. 22nd ed. Volume 1. MICROMEDEX Thomson Health Care, Greenwood Village, CO. 2002. Content Reviewed and Approved by the U.S. Pharmacopeial Convention, Inc., p. 1661

    For more Therapeutic Uses (Complete) data for HYDRALAZINE HYDROCHLORIDE (6 total), please visit the HSDB record page.

    4.3 Drug Warning

    Following parenteral administration to patients with coronary artery disease, the myocardial ischemia may be sufficiently severe and protracted to cause frank myocardial infarction. For this reason, parenteral administration of hydralazine is contraindicated in hypertensive patients with coronary artery disease and inadvisable for most hypertensive patients over 40 years old. In addition, if the drug is used alone, there may be salt retention with development of high-output congestive heart failure.

    Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 886

    VET: Chronic use may cause various collagen diseases & a lupus erythematosus syndrome (rats, dogs).

    Rossoff, I.S. Handbook of Veterinary Drugs. New York: Springer Publishing Company, 1974., p. 263

    Maternal Medication usually Compatible with Breast-Feeding: Hydralazine: Reported Sign or Symptom in Infant or Effect on Lactation: None. /from Table 6/

    Report of the American Academy of Pediatrics Committee on Drugs in Pediatrics 93 (1): 141 (1994)

    Use of hydralazine alone /for congestive heart failure/ is not recommended, although it may improve cardiac performance in some patients with intractable left ventricular failure.

    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. 1629

    For more Drug Warnings (Complete) data for HYDRALAZINE HYDROCHLORIDE (18 total), please visit the HSDB record page.

    4.4 Minimum/Potential Fatal Human Dose

    Highest known dose survived: adults, 10 g orally.

    Medical Economics Co; Physicians Desk Reference Generics 2nd ed p. 1553 (1996)

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Antihypertensive Agents

    Drugs used in the treatment of acute or chronic vascular HYPERTENSION regardless of pharmacological mechanism. Among the antihypertensive agents are DIURETICS; (especially DIURETICS, THIAZIDE); ADRENERGIC BETA-ANTAGONISTS; ADRENERGIC ALPHA-ANTAGONISTS; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; CALCIUM CHANNEL BLOCKERS; GANGLIONIC BLOCKERS; and VASODILATOR AGENTS. (See all compounds classified as Antihypertensive Agents.)

    Vasodilator Agents

    Drugs used to cause dilation of the blood vessels. (See all compounds classified as Vasodilator Agents.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Arteriolar Vasodilator [EPC]; Arteriolar Vasodilation [PE]
    5.3 Absorption, Distribution and Excretion

    Hydralazine is well absorbed through the GI tract, but the systemic bioavailability is low (16% in fast acetylators and 35% in slow acetylators).

    Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 886

    The peak concentration of hydralazine in plasma and the peak hypotensive effect of the drug occur within 30 to 120 minutes of ingestion. Although its half-life in plasma is about an hour, the duration of the hypotensive effect of hydralazine can last as long as 12 hours. There is no clear explanation for this discrepancy.

    Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 886

    5.4 Metabolism/Metabolites

    Compound /3-methyltriazolo(5,1-b)phthalazine/ is one of the major metabolites of hydralazine in human subjects.

    The Chemical Society. Foreign Compound Metabolism in Mammals. Volume 2: A Review of the Literature Published Between 1970 and 1971. London: The Chemical Society, 1972., p. 180

    Hydralazine is N-acetylated in the bowel and/or the liver. The rate of acetylation is genetically determined; about half of the people in the United States acetylate rapidly and half do so slowly.

    Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 886

    Since the systemic clearance exceeds hepatic blood flow, extrahepatic metabolism must occur. ... Hydralazine rapidly combines with circulating alpha-keto acids to form hydrazones, and the major metabolite recovered from the plasma is hydralazine pyruvic acid hydrazone.

    Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 886

    ... Pharmacokinetic data indicate hydralazine ... has an extensive and complex metabolism depending on acetylator status: slow acetylators undergo primary oxidative metabolism, while rapid acetylators are acetylated. ...

    PMID:2656046 Mulrow JP, Crawford MH; Clin Pharmacokinet 16 (2): 86-9 (1989)

    5.5 Biological Half-Life

    The half-life of hydralazine is 1 hour, and the systemic clearance of the drug is about 50 ml/kg per minute.

    Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 886

    5.6 Mechanism of Action

    Hydralazine causes direct relaxation of arteriolar smooth muscle. The molecular mechanism of this effect is not known. It is not a dilator of capacitance vessels (e.g., the epicardial coronary arteries) and does not relax venous smooth muscle. Hydralazine-induced vasodilatation is associated with powerful stimulation of the sympathetic nervous system, which results in increased heart rate and contractility, increased plasma renin activity, and fluid retention; all of these effects counteract the antihypertensive effect of hydralazine. Although most of the sympathetic activity is due to a baroreceptor-mediated reflex, hydralazine may stimulate the release of norepinephrine from sympathetic nerve terminals and augment myocardial contractility directly.

    Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 885

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    DMF Number : 6938

    Submission : 1987-04-20

    Status : Inactive

    Type : II

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INTERNATIONAL","customerCountry":"THAILAND","quantity":"400.00","actualQuantity":"400","unit":"KGS","unitRateFc":"140","totalValueFC":"55047","currency":"USD","unitRateINR":11543.163425000001,"date":"30-Aug-2024","totalValueINR":"4617265.37","totalValueInUsd":"55047","indian_port":"Hyderabad Air","hs_no":"29221990","bill_no":"3601749","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"THAILAND","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"Plot No. 26 & 27, Technocrat Industrial Estate (TIE), Hyderabad","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725474600,"product":"HYDRALAZINE HYDROCHLORIDE-USP BATCH NO:MBFRA24100A, MBFR24098A, MBFR24102A MFGDT: JUN 2024 RETEST DT: MAY 2027","address":"NO.201, DEVAVRATA SECTOR 17,,VASHI","city":"NAVI MUMBAI,MAHARASHTRA","supplier":"SOLARA ACTIVE PHARMA 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","supplierCountry":"INDIA","foreign_port":"SINGAPORE","customer":"TO THE ORDER OF","customerCountry":"SINGAPORE","quantity":"150.00","actualQuantity":"150","unit":"KGS","unitRateFc":"225","totalValueFC":"32813.3","currency":"USD","unitRateINR":18331.953333333335,"date":"25-Sep-2024","totalValueINR":"2749793","totalValueInUsd":"32813.3","indian_port":"Bombay Air","hs_no":"29251900","bill_no":"4337115","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"SINGAPORE","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"F-32\/W-6, M.I.D.C.,, DIST.THANE, MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727375400,"product":"HYDRALAZINE HYDROCHLORIDE - USP (52 DRUMS) WE INTEND TO CLAIM REWARDS UNDER MEIS\/RODTEP","address":"NO.201, DEVAVRATA SECTOR 17,,VASHI","city":"NAVI MUMBAI,MAHARASHTRA","supplier":"SOLARA ACTIVE PHARMA SCIENCES","supplierCountry":"INDIA","foreign_port":"NEW YORK","customer":"M\/S...","customerCountry":"UNITED STATES","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"175","totalValueFC":"162196.5","currency":"USD","unitRateINR":13592.264929999999,"date":"27-Sep-2024","totalValueINR":"13592264.93","totalValueInUsd":"162196.5","indian_port":"Mangalore Sea","hs_no":"29420090","bill_no":"4374300","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Mangalore Sea","supplierAddress":"NO.201, DEVAVRATA SECTOR 17,,VASHI, NAVI MUMBAI,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727461800,"product":"HYDRALAZINE HYDROCHLORIDE USP","address":"Plot No. 26 & 27, Technocrat Industrial Estate (TIE)","city":"Hyderabad","supplier":"COHANCE LIFESCIENCES","supplierCountry":"INDIA","foreign_port":"BANGKOK","customer":"TO THE ORDER","customerCountry":"THAILAND","quantity":"1050.00","actualQuantity":"1050","unit":"KGS","unitRateFc":"140","totalValueFC":"144272.6","currency":"USD","unitRateINR":11514.496819047619,"date":"28-Sep-2024","totalValueINR":"12090221.66","totalValueInUsd":"144272.6","indian_port":"Hyderabad ICD","hs_no":"29221990","bill_no":"4416121","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"THAILAND","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad ICD","supplierAddress":"Plot No. 26 & 27, Technocrat Industrial Estate (TIE), Hyderabad","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730226600,"product":"HYDRALAZINE HYDROCHLORIDE BP","address":"H N.8-2-269\/W\/4,1ST FLOOR,PLOT NO.","city":"BANJARA HILLS HYDERABAD,TELANGANA","supplier":"HRV GLOBAL LIFE SCIENCES","supplierCountry":"INDIA","foreign_port":"DUBAI","customer":"TO THE ORDER OF","customerCountry":"UNITED ARAB 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K","customer":"M\/S","customerCountry":"UNITED STATES","quantity":"75.00","actualQuantity":"75","unit":"KGS","unitRateFc":"1210.6","totalValueFC":"86539","currency":"USD","unitRateINR":97371.589066666667,"date":"02-Nov-2024","totalValueINR":"7302869.18","totalValueInUsd":"86539","indian_port":"Bangalore Air","hs_no":"29420090","bill_no":"5324336","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Bangalore Air","supplierAddress":"NO.201, DEVAVRATA SECTOR 17,,VASHI, NAVI MUMBAI,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731263400,"product":"ACTIVE PHARMACEUTICALS INGREDIENTS (API)EXPORT INVOICE NUMBER : F32512200869DT. 07.11.2024 HYDRALAZINE HYDROCHLORIDE","address":"PLOT 170-172, CHANDRAMOULI,INDUSTR","city":"SOLAPUR,MAHARASHTRA","supplier":"GLENMARK PHARMACEUTICALS","supplierCountry":"INDIA","foreign_port":"BANGKOK MODERN TERMI","customer":"TO THE ORDER","customerCountry":"THAILAND","quantity":"925.00","actualQuantity":"925","unit":"KGS","unitRateFc":"125","totalValueFC":"112720.2","currency":"USD","unitRateINR":10283.518237837838,"date":"11-Nov-2024","totalValueINR":"9512254.37","totalValueInUsd":"112720.2","indian_port":"Dahez-SEZ","hs_no":"29280090","bill_no":"5497249","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"THAILAND","selfForZScoreResived":"Pharma Grade","supplierPort":"Dahez-SEZ","supplierAddress":"PLOT 170-172, CHANDRAMOULI,INDUSTR, SOLAPUR,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731349800,"product":"PHARMACEUTICAL RAW MATERIAL-BULK DRUG (MFG TAX INV NO:IN3700001043 DT:05.11.2024) HYDRALAZINE HYDROCHLORIDE USP","address":"A-201\/202, NAVBHARAT EST.,","city":"MUMBAI ,MAHARASHTRA","supplier":"GEMINI EXPORTS","supplierCountry":"INDIA","foreign_port":"GUARULHOS","customer":"TO THE ORDER OF","customerCountry":"BRAZIL","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"237","totalValueFC":"10150.9","currency":"USD","unitRateINR":17132.253000000001,"date":"12-Nov-2024","totalValueINR":"856612.65","totalValueInUsd":"10150.9","indian_port":"Bombay Air","hs_no":"29221990","bill_no":"5543820","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BRAZIL","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"A-201\/202, NAVBHARAT EST.,, MUMBAI ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732732200,"product":"HYDRALAZINE HYDROCHLORIDE-PH.EUR BATCH NO: MBFR24150A MFG DT: SEP 2024 RETEST DT: AUG 2027","address":"NO.201, DEVAVRATA SECTOR 17,,VASHI","city":"NAVI MUMBAI,MAHARASHTRA","supplier":"SOLARA ACTIVE PHARMA SCIENCES","supplierCountry":"INDIA","foreign_port":"TALLINN","customer":"M\/S","customerCountry":"ESTONIA","quantity":"13.00","actualQuantity":"13","unit":"KGS","unitRateFc":"2600","totalValueFC":"32188.8","currency":"USD","unitRateINR":208950.03307692308,"date":"28-Nov-2024","totalValueINR":"2716350.43","totalValueInUsd":"32188.8","indian_port":"Bangalore Air","hs_no":"29420090","bill_no":"5977039","productDescription":"API","marketType":"REGULATED MARKET","country":"ESTONIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bangalore Air","supplierAddress":"NO.201, DEVAVRATA SECTOR 17,,VASHI, NAVI MUMBAI,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734373800,"product":"BULK DRUGS : HYDRALAZINE HYDROCHLORIDE PH.EUR BATCH NO. MBFR24131A","address":"Shop No 01, Floor No 3rd Pruthvi Plaza no-6 Indralok Phase 6, Opp Saraswat Bank ,? Bhayander East ,? Thane , ?THANE ,? MAHARASHTRA,? 401105","city":"N\/A","supplier":"PAVIN PHARMA PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"BRUSSELS","customer":"TO THE ORDER OF.","customerCountry":"BELGIUM","quantity":"30.00","actualQuantity":"30","unit":"KGS","unitRateFc":"309.5","totalValueFC":"9168.2","currency":"USD","unitRateINR":25967.049999999999,"date":"17-Dec-2024","totalValueINR":"779011.5","totalValueInUsd":"9168.2","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"6534419","productDescription":"API","marketType":"REGULATED MARKET","country":"BELGIUM","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"Shop No 01, Floor No 3rd Pruthvi Plaza no-6 Indralok Phase 6, Opp Saraswat Bank ,? Bhayander East ,? Thane , ?THANE ,? MAHARASHTRA,? 401105, N\/A","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734719400,"product":"ACTIVE PHARMACEUTICALS INGREDIENTS (API)EXPORT INVOICE NUMBER : F32512201075 DT.17.12.2024 HYDRALAZINE HYDROCHLORIDE","address":"PLOT 170-172, CHANDRAMOULI,INDUSTR","city":"SOLAPUR,MAHARASHTRA","supplier":"GLENMARK PHARMACEUTICALS","supplierCountry":"INDIA","foreign_port":"BANGKOK","customer":"N\/A","customerCountry":"THAILAND","quantity":"600.00","actualQuantity":"600","unit":"KGS","unitRateFc":"122.1","totalValueFC":"72648.9","currency":"USD","unitRateINR":10288.178333333333,"date":"21-Dec-2024","totalValueINR":"6172907","totalValueInUsd":"72648.9","indian_port":"Dahez-SEZ","hs_no":"29280090","bill_no":"6651931","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"THAILAND","selfForZScoreResived":"Pharma Grade","supplierPort":"Dahez-SEZ","supplierAddress":"PLOT 170-172, CHANDRAMOULI,INDUSTR, SOLAPUR,MAHARASHTRA","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q3","strtotime":1631644200,"product":"RE-IMPORT HYDRALAZINE HYDROCHLORIDE USP(SHIPPING BILL NO: 9573595 DT 10.01.2020)","address":"HETERO HOUSE,H.NO.8-3-166\/7\/1ERRAGADDA","city":"HYDERABAD","supplier":"INVAGEN PHARMACEUTICALS INC","supplierCountry":"INDIA","foreign_port":"#N\/A","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"99.85","actualQuantity":"99.85","unit":"KGS","unitRateFc":"300","totalValueFC":"30115.3","currency":"USD","unitRateINR":"22185","date":"15-Sep-2021","totalValueINR":"2215172.25","totalValueInUsd":"30115.3","indian_port":"MADRAS AIR","hs_no":"29339990","bill_no":"5447229","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"#N\/A","supplierAddress":"","customerAddress":"HETERO HOUSE,H.NO.8-3-166\/7\/1ERRAGADDA"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1634841000,"product":"RE-IMPORT HYDRALAZINE HYDROCHLORIDE USP(SHIPPING BILL NO: 9573595 DT 10.01.2020)","address":"HETERO CORPORATE, NO. 7-2-A2, INDUSTRIAL ESTATE,SANATHNAGAR Conta","city":"HYDERABAD","supplier":"INVAGEN PHARMACEUTICALS INC","supplierCountry":"INDIA","foreign_port":"NA","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"99.85","actualQuantity":"99.85","unit":"KGS","unitRateFc":"300","totalValueFC":"30310.1","currency":"USD","unitRateINR":"22740","date":"22-Oct-2021","totalValueINR":"2270589","totalValueInUsd":"30310.1","indian_port":"MADRAS AIR","hs_no":"29339990","bill_no":"5944610","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"HETERO CORPORATE, NO. 7-2-A2, INDUSTRIAL ESTATE,SANATHNAGAR Conta"}]
    13-Jan-2021
    21-Dec-2024
    KGS
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 37.5MG;20MG

    USFDA APPLICATION NUMBER - 20727

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    DOSAGE - TABLET;ORAL - 25MG

    USFDA APPLICATION NUMBER - 88467

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    DOSAGE - TABLET;ORAL - 50MG

    USFDA APPLICATION NUMBER - 88468

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    USP

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    ABOUT THIS PAGE

    Hyperex Manufacturers

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

    Hyperex Suppliers

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

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

    Hyperex USDMF

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

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

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

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

    Hyperex CEP

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

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

    Hyperex WC

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

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

    Hyperex 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 Hyperex as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Hyperex GMP

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

    Hyperex CoA

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

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

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