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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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21-Jan-2021
12-Nov-2024
KGS
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Average Price (USD/KGS)

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Total Quantity (KGS)

Total Value (USD)

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

API Imports and Exports

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(USD/KGS)
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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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ABOUT THIS PAGE

Hydralazine Hydrochloride Manufacturers

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

Hydralazine Hydrochloride Suppliers

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

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

Hydralazine Hydrochloride USDMF

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

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

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

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

Hydralazine Hydrochloride CEP

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

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

Hydralazine Hydrochloride WC

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

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

Hydralazine Hydrochloride 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 Hydralazine Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Hydralazine Hydrochloride GMP

Hydralazine Hydrochloride 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 Hydralazine Hydrochloride 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 Hydralazine Hydrochloride GMP manufacturer or Hydralazine Hydrochloride GMP API supplier for your needs.

Hydralazine Hydrochloride CoA

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

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

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