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    Chemistry

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    Also known as: 100643-71-8, Clarinex, Descarboethoxyloratadine, Desloratidine, Neoclarityn, Aerius
    Molecular Formula
    C19H19ClN2
    Molecular Weight
    310.8  g/mol
    InChI Key
    JAUOIFJMECXRGI-UHFFFAOYSA-N
    FDA UNII
    FVF865388R
    Desloratadine
    Desloratadine is a long-acting piperidine derivate with selective H1 antihistaminergic and non-sedating properties. Desloratadine diminishes the typical histaminergic effects on H1-receptors in bronchial smooth muscle, capillaries and gastrointestinal smooth muscle, including vasodilation, bronchoconstriction, increased vascular permeability, pain, itching and spasmodic contractions of gastrointestinal smooth muscle. Desloratadine is used to provide symptomatic relieve of allergic symptoms.
    Desloratadine is a Histamine-1 Receptor Antagonist. The mechanism of action of desloratadine is as a Histamine H1 Receptor Antagonist.
    1 2D Structure

    Desloratadine

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    13-chloro-2-piperidin-4-ylidene-4-azatricyclo[9.4.0.03,8]pentadeca-1(11),3(8),4,6,12,14-hexaene
    2.1.2 InChI
    InChI=1S/C19H19ClN2/c20-16-5-6-17-15(12-16)4-3-14-2-1-9-22-19(14)18(17)13-7-10-21-11-8-13/h1-2,5-6,9,12,21H,3-4,7-8,10-11H2
    2.1.3 InChI Key
    JAUOIFJMECXRGI-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    C1CC2=C(C=CC(=C2)Cl)C(=C3CCNCC3)C4=C1C=CC=N4
    2.2 Other Identifiers
    2.2.1 UNII
    FVF865388R
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Aerius

    2. Clarinex

    3. Descarboethoxyloratadine

    4. Descarboethoxyloratadine Acetate

    5. Neoclarityn

    6. Sch 34117

    7. Sch-34117

    2.3.2 Depositor-Supplied Synonyms

    1. 100643-71-8

    2. Clarinex

    3. Descarboethoxyloratadine

    4. Desloratidine

    5. Neoclarityn

    6. Aerius

    7. Azomyr

    8. Sch-34117

    9. Denosin

    10. Allex

    11. Opulis

    12. Sch 34117

    13. 8-chloro-11-piperidin-4-ylidene-6,11-dihydro-5h-benzo[5,6]cyclohepta[1,2-b]pyridine

    14. Descarboethoxyoratidine

    15. Desloratadine Actavis

    16. Dasselta

    17. Desloratadine Teva

    18. Mfcd00871949

    19. 8-chloro-11-(piperidin-4-ylidene)-6,11-dihydro-5h-benzo[5,6]cyclohepta[1,2-b]pyridine

    20. Nsc-759824

    21. Chembl1172

    22. Loratadine Related Compound A

    23. 8-chloro-6,11-dihydro-11-(4-piperidinylidene)-5h-benzo(5,6)cyclohepta(1,2-b)pyridine

    24. Mls000559042

    25. Chebi:291342

    26. Fvf865388r

    27. Nsc675447

    28. 5h-benzo[5,6]cyclohepta[1,2-b]pyridine, 8-chloro-6,11-dihydro-11-(4-piperidinylidene)-

    29. 13-chloro-2-piperidin-4-ylidene-4-azatricyclo[9.4.0.03,8]pentadeca-1(11),3(8),4,6,12,14-hexaene

    30. Ncgc00159325-02

    31. Smr000149358

    32. Desloratadine [usan]

    33. Clarinex Reditabs

    34. 8-chloro-6,11-dihydro-11-(4-piperidinylidene)-5h-benzo[5,6]cyclohepta[1,2-b]pyridine

    35. Dsstox_cid_24196

    36. Dsstox_rid_80112

    37. Dsstox_gsid_44196

    38. Desalex

    39. 5h-benzo(5,6)cyclohepta(1,2-b)pyridine, 8-chloro-6,11-dihydro-11-(4-piperidinylidene)-

    40. 8-chloro-11-piperidin-4-ylidene-5,6-dihydrobenzo[1,2]cyclohepta[2,4-b]pyridine

    41. 8-chloro-6,11-dihydro-11-(4-piperdinylidene)- 5h-benzo[5,6]cyclohepta[1,2-b]pyridine

    42. Clarinex (tn)

    43. 13-chloro-2-(piperidin-4-ylidene)-4-azatricyclo[9.4.0.0^{3,8}]pentadeca-1(11),3(8),4,6,12,14-hexaene

    44. 8-chloro-11-(piperidin-4-ylidene)-6,11-dihydro-5h-benzo[5,6]cyclohepta[1,2-b]pyridine (descarboethoxyloratadine; Desloratadine)

    45. Cas-100643-71-8

    46. Sr-01000668962

    47. Unii-fvf865388r

    48. Desloratadine [usan:inn:ban]

    49. 4-(8-chloro-5,6-dihydro-11h-benzo[5,6]cyclohepta(1,2-b]pyridin-11-ylidene)-piperidine

    50. 4-(8-chloro-5,6-dihydro-11h-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)piperidine

    51. 4-{8-chloro-5,6-dihydro-11h-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene}-piperidine

    52. 4-{8-chloro-5,6-dihydro-11h-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene}piperidine

    53. Desloratadine-[d7]

    54. Desloratadine- Bio-x

    55. Mk-4117

    56. Cpd000149358

    57. Opera_id_1891

    58. Desloratadine [mi]

    59. Desloratadine [inn]

    60. Desloratadine [jan]

    61. Schembl4425

    62. Desloratadine [vandf]

    63. Mls000759406

    64. Mls001201801

    65. Mls001424247

    66. Desloratadine [mart.]

    67. Sch34117

    68. Desloratadine Ratiopharm

    69. Desloratadine [usp-rs]

    70. Desloratadine [who-dd]

    71. Desloratadine (jan/usp/inn)

    72. Gtpl7157

    73. Zinc1261

    74. Desloratadine [ema Epar]

    75. Dtxsid1044196

    76. Loratadine Related Compound A Rs

    77. Hms2052h05

    78. Hms2090c06

    79. Hms2093f19

    80. Hms3394h05

    81. Hms3652o15

    82. Hms3715j15

    83. Hms3885c18

    84. Pharmakon1600-01505393

    85. Desloratadine [orange Book]

    86. Albb-027276

    87. Bcp02340

    88. Desloratadine For System Suitability

    89. Hy-b0539

    90. Desloratadine [ep Monograph]

    91. Tox21_111574

    92. Bbl010777

    93. Bdbm50073179

    94. Desloratadine [usp Monograph]

    95. Nsc759824

    96. S4012

    97. Stk586537

    98. Akos000280921

    99. Tox21_111574_1

    100. Ac-1279

    101. Ccg-101162

    102. Db00967

    103. Ks-1048

    104. Nc00412

    105. Nsc 675447

    106. Nsc 759824

    107. Nsc-675447

    108. Sb17503

    109. Clarinex-d Component Desloratadine

    110. Desloratadine 100 Microg/ml In Methanol

    111. Desloratadine, Powder, >=98% (hplc)

    112. Ncgc00159325-03

    113. Ncgc00159325-04

    114. Ncgc00159325-05

    115. Bd164361

    116. Loratadine Ep Impurity D (desloratadine)

    117. Sbi-0206828.p001

    118. Loratadine Impurity D [ep Impurity]

    119. D3787

    120. Desloratadine Component Of Clarinex-d

    121. Ft-0602522

    122. Ft-0666048

    123. Sw197792-3

    124. A19515

    125. D03693

    126. H11943

    127. Loratadine Related Compound A [usp-rs]

    128. Ab00456701-11

    129. Ab00456701-13

    130. Ab00456701_14

    131. Ab00456701_15

    132. 643d718

    133. L001025

    134. Q418060

    135. Loratadine Related Compound A [usp Impurity]

    136. Q-200936

    137. Rupatadine Fumarate Impurity B [ep Impurity]

    138. Sr-01000668962-4

    139. Sr-01000668962-5

    140. Sr-01000668962-8

    141. Brd-k82357231-001-13-4

    142. Desloratadine Teva (authorized: Rhinitis, Urticaria)

    143. Desloratadine Actavis (authorized: Rhinitis, Urticaria)

    144. Desloratadine, European Pharmacopoeia (ep) Reference Standard

    145. Desloratadine Ratiopharm (authorized: Rhinitis, Urticaria)

    146. Desloratadine, United States Pharmacopeia (usp) Reference Standard

    147. 4-(8-chloro-5,6-dihydro-11 H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)piperidine

    148. 4-(8-chloro-5,6-dihydro-11h-benzo-[5,6]cyclohepta(1,2-b]pyridin-11-ylidene)-piperidine

    149. 4-(8-chloro-5,6-dihydro-11h-benzo[5,6]cyclohepta [1,2-b]pyridin-11-ylidene) Piperidine

    150. 4-(8-chloro-5,6-dihydro-11h-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene) Piperidine

    151. 8-chloro-11-(4-piperidinylidene)-6,11-dihydro-5h- Benzo[4,5]cyclohepta[2,1-b]pyridine

    152. 8-chloro-11-(4-piperidyliden)-6,11-dihydro-5h-benzo[5,6]cyclohepta [1,2-b]pyridine

    153. 8-chloro-11-(4-piperidyliden)-6,11-dihydro-5h-benzo[5,6]cyclohepta[1,2-b]pyridine

    154. 8-chloro-11-(4-piperidylidene)-6,11-dihydro-5h-benzo[5.6]cyclohepta[1,2-b]pyridine

    155. 8-chloro-6,11-dihydro-11-(4-piperidylidene)-5h-benzo[5,6]cyclohepta[1,2-b]pyridine

    156. Desloratadine For System Suitability, European Pharmacopoeia (ep) Reference Standard

    157. Desloratidine, Pharmaceutical Secondary Standard; Certified Reference Material

    158. Loratadine Related Compound A, United States Pharmacopeia (usp) Reference Standard

    159. 13-chloro-2-(piperidin-4-ylidene)-4-azatricyclo[9.4.0.0^{3,8}]pentadeca-1(11),3,5,7,12,14-hexaene

    160. 8-chloro-11-(4-piperidylidene)-6,11-dihydro-5h-benzo[5,6]cyclohepta[1,2-b]pyridine

    161. 8-chloro-6,11-dihydro-11(4-piperidylidene)-5h-benzo(5,6)cyclohepta(1,2-b) Pyridine

    162. 8-chloro-6,11-dihydro-11-(4-piperidinylidene)-5h-benzo(5,6)cyclohepta(1,2-bpyridine

    163. 8-chloro-6,11-dihydro-11-(4-piperidinylidene)-5h-benzo(5,6)cyclohepta(1,2b)pyridine

    2.4 Create Date
    2005-03-26
    3 Chemical and Physical Properties
    Molecular Weight 310.8 g/mol
    Molecular Formula C19H19ClN2
    XLogP34.5
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count2
    Rotatable Bond Count0
    Exact Mass310.1236763 g/mol
    Monoisotopic Mass310.1236763 g/mol
    Topological Polar Surface Area24.9 Ų
    Heavy Atom Count22
    Formal Charge0
    Complexity425
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameClarinex
    PubMed HealthDesloratadine (By mouth)
    Drug ClassesRespiratory Agent
    Drug LabelCLARINEX (desloratadine) Tablets are light blue, round, film-coated tablets containing 5 mg desloratadine, an antihistamine, to be administered orally. CLARINEX Tablets also contain the following excipients: dibasic calcium phosphate dihydrate USP, m...
    Active IngredientDesloratadine
    Dosage FormTablet, orally disintegrating; Tablet; Syrup; Solution
    Routeoral; Oral
    Strength2.5mg; 5mg; 0.5mg/ml
    Market StatusPrescription
    CompanyMerck Sharp Dohme; Schering

    2 of 4  
    Drug NameDesloratadine
    PubMed HealthDesloratadine (By mouth)
    Drug ClassesRespiratory Agent
    Drug LabelDesloratadine tablets are blue, round, film-coated tablets debossed with logo L5 on one side containing 5 mg desloratadine, an antihistamine, to be administered orally. Desloratadine tablets also contain the following excipients: carnauba wax,...
    Active IngredientDesloratadine
    Dosage FormTablet, orally disintegrating; Tablet
    Routeoral; Oral
    Strength2.5mg; 5mg
    Market StatusTentative Approval; Prescription
    CompanyPerrigo R And D; Mylan Pharms; Glenmark Generics; Belcher Pharms; Lupin Pharms; Sun Pharm Inds; Reddys; Zydus Pharms Usa; Dr Reddys Labs; Sandoz; Orchid Hlthcare

    3 of 4  
    Drug NameClarinex
    PubMed HealthDesloratadine (By mouth)
    Drug ClassesRespiratory Agent
    Drug LabelCLARINEX (desloratadine) Tablets are light blue, round, film-coated tablets containing 5 mg desloratadine, an antihistamine, to be administered orally. CLARINEX Tablets also contain the following excipients: dibasic calcium phosphate dihydrate USP, m...
    Active IngredientDesloratadine
    Dosage FormTablet, orally disintegrating; Tablet; Syrup; Solution
    Routeoral; Oral
    Strength2.5mg; 5mg; 0.5mg/ml
    Market StatusPrescription
    CompanyMerck Sharp Dohme; Schering

    4 of 4  
    Drug NameDesloratadine
    PubMed HealthDesloratadine (By mouth)
    Drug ClassesRespiratory Agent
    Drug LabelDesloratadine tablets are blue, round, film-coated tablets debossed with logo L5 on one side containing 5 mg desloratadine, an antihistamine, to be administered orally. Desloratadine tablets also contain the following excipients: carnauba wax,...
    Active IngredientDesloratadine
    Dosage FormTablet, orally disintegrating; Tablet
    Routeoral; Oral
    Strength2.5mg; 5mg
    Market StatusTentative Approval; Prescription
    CompanyPerrigo R And D; Mylan Pharms; Glenmark Generics; Belcher Pharms; Lupin Pharms; Sun Pharm Inds; Reddys; Zydus Pharms Usa; Dr Reddys Labs; Sandoz; Orchid Hlthcare

    4.2 Drug Indication

    For the relief of symptoms of seasonal allergic rhinitis, perennial (non-seasonal) allergic rhinitis. Desloratidine is also used for the sympomatic treatment of pruritus and urticaria (hives) associated with chronic idiopathic urticaria.

    FDA Label

    Azomyr is indicated for the relief of symptoms associated with:

    - allergic rhinitis (see section 5. 1)

    - urticaria (see section 5. 1)

    Aerius is indicated for the relief of symptoms associated with:

    - allergic rhinitis;

    - urticaria.

    Neoclarityn is indicated for the relief of symptoms associated with:

    - allergic rhinitis

    - urticaria

    Treatment of allergic rhinitis and urticaria.

    Desloratadine Teva is indicated for the relief of symptoms associated with:

    - allergic rhinitis;

    - urticaria.

    Dasselta is indicated for the relief of symptoms associated with:

    - allergic rhinitis;

    - urticaria.

    Desloratadine ratiopharm is indicated in adults for the relief of symptoms associated with:

    - allergic rhinitis

    - chronic idiopathic urticaria as initially diagnosed by a physician

    Aerius is indicated for the relief of symptoms associated with:

    - allergic rhinitis (see section 5. 1)

    - urticaria (see section 5. 1)

    Opulis is indicated for the relief of symptoms associated with:

    - allergic rhinitis (see section 5. 1)

    - urticaria (see section 5. 1)

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Desloratadine is a long-acting second-generation H1-receptor antagonist which has a selective and peripheral H1-antagonist action. Histamine is a chemical that causes many of the signs that are part of allergic reactions, such as the swelling of tissues. Histamine is released from histamine-storing cells (mast cells) and attaches to other cells that have receptors for histamine. The attachment of the histamine to the receptors causes the cell to be "activated," releasing other chemicals which produce the effects that we associate with allergies. Desloratadine blocks one type of receptor for histamine (the H1 receptor) and thus prevents activation of cells by histamine. Unlike most other antihistamines, Desloratadine does not enter the brain from the blood and, therefore, does not cause drowsiness.

    5.2 MeSH Pharmacological Classification

    Cholinergic Antagonists

    Drugs that bind to but do not activate CHOLINERGIC RECEPTORS, thereby blocking the actions of ACETYLCHOLINE or cholinergic agonists. (See all compounds classified as Cholinergic Antagonists.)

    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.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    DESLORATADINE
    5.3.2 FDA UNII
    FVF865388R
    5.3.3 Pharmacological Classes
    Histamine-1 Receptor Antagonist [EPC]; Histamine H1 Receptor Antagonists [MoA]
    5.4 ATC Code

    R06AX27

    R06AX27

    R06AX27

    R06AX27

    R06AX27

    R06AX27

    R06AX27

    R06AX27

    R06AX27

    R06AX27

    S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

    R - Respiratory system

    R06 - Antihistamines for systemic use

    R06A - Antihistamines for systemic use

    R06AX - Other antihistamines for systemic use

    R06AX27 - Desloratadine

    5.5 Absorption, Distribution and Excretion

    Absorption

    Desloratadine administered orally for ten days to healthy volunteers as a 5 mg tablet once daily resulted in a mean Tmax of approximately 3 hours, a mean steady-state Cmax of 4 ng/ml, and a mean steady-state AUC of 56.9 ng\*hr/ml. A similar profile was observed using 10 ml of an oral solution containing 5 mg of desloratadine. Food was found not to affect desloratadine absorption.

    Route of Elimination

    Approximately 87% of a 14C-desloratadine dose was equally recovered in urine and feces as metabolic products.

    5.6 Metabolism/Metabolites

    Desloratadine is metabolized to the active metabolite 3-hydroxydesloratadine, which is subsequently glucuronidated.

    Desloratadine is a known human metabolite of Rupatadine and loratadine.

    S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560

    5.7 Biological Half-Life

    Desloratadine has a mean plasma elimination half-life of approximately 27 hours.

    5.8 Mechanism of Action

    Like other H1-blockers, Desloratadine competes with free histamine for binding at H1-receptors in the GI tract, uterus, large blood vessels, and bronchial smooth muscle. This blocks the action of endogenous histamine, which subsequently leads to temporary relief of the negative symptoms (eg. nasal congestion, watery eyes) brought on by histamine.

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    DOSAGE - TABLET;ORAL - 5MG

    USFDA APPLICATION NUMBER - 21165

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    DOSAGE - SOLUTION;ORAL - 0.5MG/ML **Federal R...DOSAGE - SOLUTION;ORAL - 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 21300

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 2.5M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 2.5MG;120MG

    USFDA APPLICATION NUMBER - 21313

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    30

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

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

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

    API | Excipient name

    Desloratadine

    Synonyms

    100643-71-8, Clarinex, Descarboethoxyloratadine, Desloratidine, Neoclarityn, Aerius

    Cas Number

    100643-71-8

    Unique Ingredient Identifier (UNII)

    FVF865388R

    About Desloratadine

    Desloratadine is a long-acting piperidine derivate with selective H1 antihistaminergic and non-sedating properties. Desloratadine diminishes the typical histaminergic effects on H1-receptors in bronchial smooth muscle, capillaries and gastrointestinal smooth muscle, including vasodilation, bronchoconstriction, increased vascular permeability, pain, itching and spasmodic contractions of gastrointestinal smooth muscle. Desloratadine is used to provide symptomatic relieve of allergic symptoms.

    Azomyr Manufacturers

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

    Azomyr Suppliers

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

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

    Azomyr USDMF

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

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

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

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

    Azomyr KDMF

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

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

    After submitting a Azomyr 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 Azomyr API can apply through the Korea Drug Master File (KDMF).

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

    Azomyr CEP

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

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

    Azomyr WC

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

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

    Azomyr 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 Azomyr as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Azomyr GMP

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

    Azomyr CoA

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

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

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