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    Chemistry

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    Also known as: Azelastine hcl, 79307-93-0, Optivar, Astelin, Allergodil, Rhinolast
    Molecular Formula
    C22H25Cl2N3O
    Molecular Weight
    418.4  g/mol
    InChI Key
    YEJAJYAHJQIWNU-UHFFFAOYSA-N
    FDA UNII
    0L591QR10I
    Azelastine Hydrochloride
    Azelastine Hydrochloride is the hydrochloride salt form of azelastine, a phthalazinone derivative with antihistaminergic activity. Azelastine hydrochloride competes with histamine for the H1 receptor, thereby diminishing the actions of histamine on effector cells and decreasing the histamine-mediated symptoms of allergic reaction, such as bronchoconstriction, vasodilation, increased capillary permeability and spasmodic contractions of gastrointestinal smooth muscle.
    1 2D Structure

    Azelastine Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    4-[(4-chlorophenyl)methyl]-2-(1-methylazepan-4-yl)phthalazin-1-one;hydrochloride
    2.1.2 InChI
    InChI=1S/C22H24ClN3O.ClH/c1-25-13-4-5-18(12-14-25)26-22(27)20-7-3-2-6-19(20)21(24-26)15-16-8-10-17(23)11-9-16;/h2-3,6-11,18H,4-5,12-15H2,1H3;1H
    2.1.3 InChI Key
    YEJAJYAHJQIWNU-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CN1CCCC(CC1)N2C(=O)C3=CC=CC=C3C(=N2)CC4=CC=C(C=C4)Cl.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    0L591QR10I
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 4-((4-chlorophenyl)methyl)-2- (hexahydro-1-methyl-1h-azepin-4-yl)-1(2h)- Phthalazinone Hcl

    2. 4-(p-chlorobenzyl)-2-(n-methylperhydroazepinyl-(4))-1-(2h)-phthalazinone

    3. A 5610

    4. A-5610

    5. Afluon

    6. Allergodil

    7. Astelin

    8. Azelastine

    9. Azeptin

    10. Corifina

    11. Loxin

    12. Optilast

    13. Optivar

    14. Rhinolast

    15. Vividrin Akut Azelastin

    2.3.2 Depositor-Supplied Synonyms

    1. Azelastine Hcl

    2. 79307-93-0

    3. Optivar

    4. Astelin

    5. Allergodil

    6. Rhinolast

    7. Astepro

    8. Azeptin

    9. Azelastine (hydrochloride)

    10. 37932-96-0

    11. W-2979m

    12. 4-(4-chlorobenzyl)-2-(1-methylazepan-4-yl)phthalazin-1(2h)-one Hydrochloride

    13. A-5610

    14. E-0659

    15. Optilast

    16. 4-[(4-chlorophenyl)methyl]-2-(1-methylazepan-4-yl)phthalazin-1-one;hydrochloride

    17. Chebi:2951

    18. 0l591qr10i

    19. 4-(p-chlorobenzyl)-2-(hexahydro-1-methyl-1h-azepin-4-yl)-1(2h)-phthalazinone Monohydrochloride

    20. Ncgc00095173-01

    21. Dsstox_cid_25945

    22. Dsstox_rid_81243

    23. Dsstox_gsid_45945

    24. 1(2h)-phthalazinone, 4-((4-chlorophenyl)methyl)-2-(hexahydro-1-methyl-1h-azepin-4-yl)-, Monohydrochloride

    25. 4-[(4-chlorophenyl)methyl]-2-(hexahydro-1-methyl-1h-azepin-4-yl)phthalazin-1(2h)-one Hydrochloride

    26. Corifina

    27. Optilas

    28. (r)-azelastine Hcl

    29. (s)-azelastine Hcl

    30. 4-((4-chlorophenyl)methyl)-2-(hexahydro-1-methyl-1h-azepin-4-yl)phthalazin-1(2h)-one Hydrochloride

    31. Smr000469183

    32. Cas-79307-93-0

    33. Radethazin

    34. Zalastine

    35. Azep

    36. Sr-01000762975

    37. A 5610

    38. Astelin (tn)

    39. Einecs 253-720-4

    40. Azelastine Hydrochloride [usan:jan]

    41. Mfcd00242783

    42. Astepro Allergy

    43. Cpd000469183

    44. Schembl36770

    45. Mls001401427

    46. Mls006010756

    47. Spectrum1505340

    48. Unii-0l591qr10i

    49. Azelastine Hydrochloride- Bio-x

    50. Chembl1200809

    51. Dtxsid2045945

    52. Azelastine Hydrochloride (astelin)

    53. Bcpp000358

    54. Hms1922f04

    55. Pharmakon1600-01505340

    56. Bcp23404

    57. Hy-b0462

    58. Tox21_111469

    59. Azelastine Hydrochloride [mi]

    60. Ccg-40046

    61. Nsc758971

    62. Azelastine Hydrochloride (jp17/usp)

    63. Azelastine Hydrochloride [jan]

    64. Akos015895420

    65. Tox21_111469_1

    66. Ac-5498

    67. Azelastine Hydrochloride [usan]

    68. Bcp9000369

    69. Ccg-100841

    70. Nc00091

    71. W- 979m

    72. Azelastine Hydrochloride [mart.]

    73. Azelastine Hydrochloride [vandf]

    74. Azelastine Hydrochloride [usp-rs]

    75. Azelastine Hydrochloride [who-dd]

    76. Ncgc00095173-02

    77. Ncgc00177979-05

    78. Allergodil Pound>>azelastine Hydrochloride

    79. As-14079

    80. Ba164232

    81. Azelastine Hydrochloride, >=98% (hplc)

    82. Bcp0726000233

    83. Ft-0662380

    84. Ft-0662381

    85. S2552

    86. Sw197471-3

    87. Azelastine Hydrochloride [orange Book]

    88. Azelastine Hydrochloride [ep Monograph]

    89. Azelastine Hydrochloride [usp Monograph]

    90. C76537

    91. D00659

    92. Dymista Component Azelastine Hydrochloride

    93. 307a930

    94. Azelastine Hydrochloride Component Of Dymista

    95. Sr-01000762975-4

    96. Q27105897

    97. Azelastine Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)

    98. 4-(4-chlorobenzyl)-2-(1-methylazepan-4-yl)-1-phthalazinone Hydrochloride

    99. Azelastine Hydrochloride, European Pharmacopoeia (ep) Reference Standard

    100. 4-(4-chlorobenzyl)-2-(1-methylazepan-4-yl)phthalazin-1(2h)-onehydrochloride

    101. 4-[(4-chlorophenyl)methyl]-2-(1-methyl-4-azepanyl)phthalazin-1-one Hydrochloride

    102. Azelastine Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

    103. Azelastine Hydrochloride, United States Pharmacopeia (usp) Reference Standard

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 418.4 g/mol
    Molecular Formula C22H25Cl2N3O
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count3
    Rotatable Bond Count3
    Exact Mass417.1374678 g/mol
    Monoisotopic Mass417.1374678 g/mol
    Topological Polar Surface Area35.9 Ų
    Heavy Atom Count28
    Formal Charge0
    Complexity558
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count1
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 8  
    Drug NameAstelin
    PubMed HealthAzelastine (Into the nose)
    Drug ClassesNasal Agent
    Drug LabelAstelin (azelastine hydrochloride) Nasal Spray, 137 micrograms (mcg), is an antihistamine formulated as a metered-spray solution for intranasal administration. Azelastine hydrochloride occurs as a white, almost odorless, crystalline powder with a b...
    Active IngredientAzelastine hydrochloride
    Dosage FormSpray, metered
    RouteNasal
    Strengtheq 0.125mg base/spray
    Market StatusPrescription
    CompanyMeda Pharms

    2 of 8  
    Drug NameAstepro
    Drug LabelASTEPRO (azelastine hydrochloride) Nasal Spray 0.1%, 137 micrograms (mcg), is an antihistamine formulated as a metered-spray solution for intranasal administration. ASTEPRO (azelastine hydrochloride) Nasal Spray 0.15%, 205.5 micrograms (mcg), is form...
    Active IngredientAzelastine hydrochloride
    Dosage FormSpray, metered
    RouteNasal
    Strengtheq 0.1876mg base/spray
    Market StatusPrescription
    CompanyMeda Pharms

    3 of 8  
    Drug NameAzelastine hydrochloride
    Drug LabelASTEPRO (azelastine hydrochloride) Nasal Spray 0.1%, 137 micrograms (mcg), is an antihistamine formulated as a metered-spray solution for intranasal administration. ASTEPRO (azelastine hydrochloride) Nasal Spray 0.15%, 205.5 micrograms (mcg), is form...
    Active IngredientAzelastine hydrochloride
    Dosage FormSolution/drops; Spray, metered
    RouteNasal; Ophthalmic
    Strength0.05%; eq 0.125mg base/spray; eq 0.1876mg base/spray
    Market StatusPrescription
    CompanyAlcon Pharma; Apotex; Sun Pharma Global; Perrigo Israel

    4 of 8  
    Drug NameOptivar
    PubMed HealthAzelastine
    Drug ClassesNasal Agent, Ophthalmologic Agent
    Drug LabelOPTIVAR (azelastine hydrochloride ophthalmic solution), 0.05% is a sterile ophthalmic solution containing azelastine hydrochloride, a relatively selective H1-receptor antagonist for topical administration to the eyes. Azelastine hydrochloride is a...
    Active IngredientAzelastine hydrochloride
    Dosage FormSolution/drops
    RouteOphthalmic
    Strength0.05%
    Market StatusPrescription
    CompanyMeda Pharms

    5 of 8  
    Drug NameAstelin
    PubMed HealthAzelastine (Into the nose)
    Drug ClassesNasal Agent
    Drug LabelAstelin (azelastine hydrochloride) Nasal Spray, 137 micrograms (mcg), is an antihistamine formulated as a metered-spray solution for intranasal administration. Azelastine hydrochloride occurs as a white, almost odorless, crystalline powder with a b...
    Active IngredientAzelastine hydrochloride
    Dosage FormSpray, metered
    RouteNasal
    Strengtheq 0.125mg base/spray
    Market StatusPrescription
    CompanyMeda Pharms

    6 of 8  
    Drug NameAstepro
    Drug LabelASTEPRO (azelastine hydrochloride) Nasal Spray 0.1%, 137 micrograms (mcg), is an antihistamine formulated as a metered-spray solution for intranasal administration. ASTEPRO (azelastine hydrochloride) Nasal Spray 0.15%, 205.5 micrograms (mcg), is form...
    Active IngredientAzelastine hydrochloride
    Dosage FormSpray, metered
    RouteNasal
    Strengtheq 0.1876mg base/spray
    Market StatusPrescription
    CompanyMeda Pharms

    7 of 8  
    Drug NameAzelastine hydrochloride
    Drug LabelASTEPRO (azelastine hydrochloride) Nasal Spray 0.1%, 137 micrograms (mcg), is an antihistamine formulated as a metered-spray solution for intranasal administration. ASTEPRO (azelastine hydrochloride) Nasal Spray 0.15%, 205.5 micrograms (mcg), is form...
    Active IngredientAzelastine hydrochloride
    Dosage FormSolution/drops; Spray, metered
    RouteNasal; Ophthalmic
    Strength0.05%; eq 0.125mg base/spray; eq 0.1876mg base/spray
    Market StatusPrescription
    CompanyAlcon Pharma; Apotex; Sun Pharma Global; Perrigo Israel

    8 of 8  
    Drug NameOptivar
    PubMed HealthAzelastine
    Drug ClassesNasal Agent, Ophthalmologic Agent
    Drug LabelOPTIVAR (azelastine hydrochloride ophthalmic solution), 0.05% is a sterile ophthalmic solution containing azelastine hydrochloride, a relatively selective H1-receptor antagonist for topical administration to the eyes. Azelastine hydrochloride is a...
    Active IngredientAzelastine hydrochloride
    Dosage FormSolution/drops
    RouteOphthalmic
    Strength0.05%
    Market StatusPrescription
    CompanyMeda Pharms

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Histamine H1 Antagonists, Non-Sedating

    A class of non-sedating drugs that bind to but do not activate histamine receptors (DRUG INVERSE AGONISM), thereby blocking the actions of histamine or histamine agonists. These antihistamines represent a heterogenous group of compounds with differing chemical structures, adverse effects, distribution, and metabolism. Compared to the early (first generation) antihistamines, these non-sedating antihistamines have greater receptor specificity, lower penetration of BLOOD-BRAIN BARRIER, and are less likely to cause drowsiness or psychomotor impairment. (See all compounds classified as Histamine H1 Antagonists, Non-Sedating.)

    Anti-Allergic Agents

    Agents that are used to treat allergic reactions. Most of these drugs act by preventing the release of inflammatory mediators or inhibiting the actions of released mediators on their target cells. (From AMA Drug Evaluations Annual, 1994, p475) (See all compounds classified as Anti-Allergic Agents.)

    Bronchodilator Agents

    Agents that cause an increase in the expansion of a bronchus or bronchial tubes. (See all compounds classified as Bronchodilator Agents.)

    Lipoxygenase Inhibitors

    Compounds that bind to and inhibit that enzymatic activity of LIPOXYGENASES. Included under this category are inhibitors that are specific for lipoxygenase subtypes and act to reduce the production of LEUKOTRIENES. (See all compounds classified as Lipoxygenase Inhibitors.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Histamine-1 Receptor Antagonist [EPC]; Histamine H1 Receptor Antagonists [MoA]

    API Reference Price

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MAHARASHTRA","supplier":"URQUIMA S.A. GRUPO URIACH","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"8.00","actualQuantity":"8000","unit":"GMS","unitRateFc":"13.5","totalValueFC":"109290.3","currency":"USD","unitRateINR":"1138.7","date":"04-May-2024","totalValueINR":"9109800","totalValueInUsd":"109290.3","indian_port":"Delhi Air","hs_no":"29420090","bill_no":"3336257","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"POL. IND. 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MAHARASHTRA","supplier":"URQUIMA S.A. GRUPO URIACH","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.50","actualQuantity":"500","unit":"GMS","unitRateFc":"13.5","totalValueFC":"6827.4","currency":"USD","unitRateINR":"1141.4","date":"26-Jul-2024","totalValueINR":"570712.5","totalValueInUsd":"6827.4","indian_port":"Delhi Air","hs_no":"29420090","bill_no":"4711387","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"POL. IND. 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MAHARASHTRA","supplier":"URQUIMA S.A. GRUPO URIACH","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"2.33","actualQuantity":"2332","unit":"GMS","unitRateFc":"11","totalValueFC":"25883.8","currency":"USD","unitRateINR":"965.3","date":"24-Feb-2025","totalValueINR":"2250963","totalValueInUsd":"25883.8","indian_port":"Delhi Air","hs_no":"29420090","bill_no":"8541667","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"POL. IND. RIERA DE CALDES PALAU-SOL ITA I PLEGAMANS 08184 BARCELONA SDNF SPAIN","customerAddress":"B\/2 MAHALAXMI CHAMBERS"}]
    01-Jan-2021
    24-Feb-2025
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    DOSAGE - SPRAY, METERED;NASAL - 0.137MG/SPRAY...DOSAGE - SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20114

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    DOSAGE - SPRAY, METERED;NASAL - 0.137MG/SPRAY...DOSAGE - SPRAY, METERED;NASAL - 0.137MG/SPRAY;0.05MG/SPRAY

    USFDA APPLICATION NUMBER - 202236

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    DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 0.05% **...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 21127

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    DOSAGE - SPRAY, METERED;NASAL - 0.137MG/SPRAY...DOSAGE - SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 22203

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    ABOUT THIS PAGE

    Looking for 79307-93-0 / Azelastine Hydrochloride API manufacturers, exporters & distributors?

    Azelastine Hydrochloride manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Azelastine Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Azelastine Hydrochloride manufacturer or Azelastine Hydrochloride supplier for your needs.

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

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

    API | Excipient name

    Azelastine Hydrochloride

    Synonyms

    Azelastine hcl, 79307-93-0, Optivar, Astelin, Allergodil, Rhinolast

    Cas Number

    79307-93-0

    Unique Ingredient Identifier (UNII)

    0L591QR10I

    About Azelastine Hydrochloride

    Azelastine Hydrochloride is the hydrochloride salt form of azelastine, a phthalazinone derivative with antihistaminergic activity. Azelastine hydrochloride competes with histamine for the H1 receptor, thereby diminishing the actions of histamine on effector cells and decreasing the histamine-mediated symptoms of allergic reaction, such as bronchoconstriction, vasodilation, increased capillary permeability and spasmodic contractions of gastrointestinal smooth muscle.

    Azep Manufacturers

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

    Azep Suppliers

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

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

    Azep USDMF

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

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

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

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

    Azep KDMF

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

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

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

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

    Azep CEP

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

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

    Azep WC

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

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

    Azep 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 Azep as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Azep GMP

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

    Azep CoA

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

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

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