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    Chemistry

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    Also known as: 83919-23-7, Asmanex, Nasonex, Elocon, Monovo, Sch 32088
    Molecular Formula
    C27H30Cl2O6
    Molecular Weight
    521.4  g/mol
    InChI Key
    WOFMFGQZHJDGCX-ZULDAHANSA-N
    FDA UNII
    04201GDN4R
    Mometasone Furoate
    A pregnadienediol derivative ANTI-ALLERGIC AGENT and ANTI-INFLAMMATORY AGENT that is used in the management of ASTHMA and ALLERGIC RHINITIS. It is also used as a topical treatment for skin disorders.
    1 2D Structure

    Mometasone Furoate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    [(8S,9R,10S,11S,13S,14S,16R,17R)-9-chloro-17-(2-chloroacetyl)-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] furan-2-carboxylate
    2.1.2 InChI
    InChI=1S/C27H30Cl2O6/c1-15-11-19-18-7-6-16-12-17(30)8-9-24(16,2)26(18,29)21(31)13-25(19,3)27(15,22(32)14-28)35-23(33)20-5-4-10-34-20/h4-5,8-10,12,15,18-19,21,31H,6-7,11,13-14H2,1-3H3/t15-,18+,19+,21+,24+,25+,26+,27+/m1/s1
    2.1.3 InChI Key
    WOFMFGQZHJDGCX-ZULDAHANSA-N
    2.1.4 Canonical SMILES
    CC1CC2C3CCC4=CC(=O)C=CC4(C3(C(CC2(C1(C(=O)CCl)OC(=O)C5=CC=CO5)C)O)Cl)C
    2.1.5 Isomeric SMILES
    C[C@@H]1C[C@H]2[C@@H]3CCC4=CC(=O)C=C[C@@]4([C@]3([C@H](C[C@@]2([C@]1(C(=O)CCl)OC(=O)C5=CC=CO5)C)O)Cl)C
    2.2 Other Identifiers
    2.2.1 UNII
    04201GDN4R
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Asmanex

    2. Asmanex Twisthaler

    3. Elocon

    4. Furoate Monohydrate, Mometasone

    5. Furoate, Mometasone

    6. Mometasone

    7. Mometasone Furoate Monohydrate

    8. Monohydrate, Mometasone Furoate

    9. Nasonex

    10. Rinelon

    11. Sch 32088

    12. Sch-32088

    13. Sch32088

    14. Twisthaler, Asmanex

    2.3.2 Depositor-Supplied Synonyms

    1. 83919-23-7

    2. Asmanex

    3. Nasonex

    4. Elocon

    5. Monovo

    6. Sch 32088

    7. Mometasone 17-furoate

    8. Sinuva

    9. Mometasone Furoate Anhydrous

    10. Sch32088

    11. Sch-32088

    12. Nsc-746171

    13. Chembl1161

    14. Lyr210

    15. (8s,9r,10s,11s,13s,14s,16r,17r)-9-chloro-17-(2-chloroacetyl)-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3h-cyclopenta[a]phenanthren-17-yl Furan-2-carboxylate

    16. [(8s,9r,10s,11s,13s,14s,16r,17r)-9-chloro-17-(2-chloroacetyl)-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] Furan-2-carboxylate

    17. Chebi:47564

    18. Lyr-210

    19. 04201gdn4r

    20. Nsc-760077

    21. (11beta,16alpha)-9,21-dichloro-17-[(2-furanylcarbonyl)oxy]-11-hydroxy-16-methylpregna-1,4-diene-3,20-dione

    22. Danitin

    23. Ecural

    24. Elomet

    25. Dsstox_cid_3333

    26. Asmanex Twisthaler

    27. Dsstox_rid_76981

    28. Dsstox_gsid_23333

    29. (9beta,10alpha,11alpha,14beta,16alpha,17alpha)-9,21-dichloro-11-hydroxy-16-methyl-3,20-dioxopregna-1,4-dien-17-yl Furan-2-carboxylate

    30. 9,21-dichloro-11beta-hydroxy-16alpha-methyl-3,20-dioxopregna-1,4-dien-17-yl Furan-2-carboxylate

    31. Elocone

    32. Flumeta

    33. Nosorex

    34. Rimelon

    35. Ovixan

    36. Asmanex Hfa

    37. Mometasone Fuorate

    38. Mof

    39. Unii-04201gdn4r

    40. Mometasone-furoate

    41. Ncgc00016950-01

    42. Prestwick_924

    43. Asmanex (tn)

    44. Mometasone Furoate [usan:usp:jan]

    45. Cas-83919-23-7

    46. Elocon (tn)

    47. Las 41002

    48. Brn 4340538

    49. Prestwick0_000572

    50. Prestwick1_000572

    51. Prestwick2_000572

    52. Prestwick3_000572

    53. Mometasone Furancarboxylate

    54. Schembl4568

    55. Bspbio_000384

    56. Mometasone 17-(2-furoate)

    57. Mls002153879

    58. Spbio_002603

    59. Mometasone Furoate (jan/usp)

    60. Bpbio1_000424

    61. Mometasone Furoate [mi]

    62. Dtxsid4023333

    63. Mometasone Furoate [jan]

    64. Mometasone Furoate [usan]

    65. Hms1569d06

    66. Hms2096d06

    67. Hms2235i14

    68. Hms3713d06

    69. Mometasone Furoate [vandf]

    70. Mometasone Furoate [mart.]

    71. Mometasone Furoate [usp-rs]

    72. Mometasone Furoate [who-dd]

    73. Zinc3938677

    74. Tox21_110705

    75. Ac-941

    76. Bdbm50148733

    77. Mfcd00866003

    78. Nsc746171

    79. S1987

    80. Mometasone Furoate, >=98% (hplc)

    81. Akos015994732

    82. Tox21_110705_1

    83. Ccg-220572

    84. Db14512

    85. Ks-1275

    86. Mometasone Furoate [green Book]

    87. Nsc 746171

    88. Nsc 760077

    89. 9,21-dichloro-11beta,17-dihydroxy-16alpha-methylpregna-1,4-diene-3,20-dione 17-(2-furoate)

    90. Mometasone Furoate [orange Book]

    91. Mometasone Furoate [ep Monograph]

    92. Ncgc00179578-01

    93. Ncgc00179578-03

    94. Ncgc00179578-04

    95. (11beta,16alpha)-9,21-dichloro-11-hydroxy-16-methyl-3,20-dioxopregna-1,4-dien-17-yl Furan-2-carboxylate

    96. Dulera Component Mometasone Furoate

    97. Hy-13693

    98. Mometasone Furoate [usp Monograph]

    99. Smr001233233

    100. M2354

    101. Mometasone Furoate Component Of Dulera

    102. C07817

    103. D00690

    104. Mometasone Furoate 1000 Microg/ml In Methanol

    105. 919m237

    106. A840685

    107. Mometasone Furoate 100 Microg/ml In Acetonitrile

    108. Sr-01000841209

    109. Lyr-220 Active Component Mometasone Furoate

    110. Q-101380

    111. Q1044248

    112. Sr-01000841209-2

    113. Brd-k60640630-001-03-7

    114. Brd-k60640630-001-11-0

    115. Mometasone Furoate, European Pharmacopoeia (ep) Reference Standard

    116. Mometasone Furoate, United States Pharmacopeia (usp) Reference Standard

    117. 11?,16?)-9,21-dichloro-11-hydroxy-16-methyl-3,20-dioxopregna-1,4-dien-17-yl 2-furoate

    118. Mometasone Furoate, Pharmaceutical Secondary Standard; Certified Reference Material

    119. (11.beta.,16.alpha.)-9,21-dichloro-17-((2-furanylcarbonyl)oxy)-11-hydroxy-16-methylpregna-1,4-diene-3,20-dione

    120. [(8s,9r,10s,11s,13s,14s,16r,17r)-9-chloro-17-(2-chloroacetyl)-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] Furan-2-carboxylate;mometasone Furoate

    121. [(9r,10s,11s,13s,16r,17r)-9-chloro-17-(2-chloroacetyl)-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] Furan-2-carboxylate

    122. 9,21-dichloro-11.beta.,17-dihydroxy-16.alpha.-methylpregna-1,4-diene-3,20-dione 17-(2-furoate)

    123. Pregna-1,20-dione, 9,21-dichloro-17-[(2-furanylcarbonyl)oxy]-11-hydroxy-16-methyl-, (11.beta.,16.alpha.)-

    124. Pregna-1,4-diene-3,20-dione, 9,21-dichloro-17-((2-furanylcarbonyl)oxy)-11-hydroxy-16-methyl-, (11.beta.,16.alpha.)

    125. Pregna-1,4-diene-3,20-dione, 9,21-dichloro-17-((2-furanylcarbonyl)oxy)-11-hydroxy-16-methyl-, (11beta,16alpha)-

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 521.4 g/mol
    Molecular Formula C27H30Cl2O6
    XLogP33.9
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count6
    Rotatable Bond Count5
    Exact Mass520.1419441 g/mol
    Monoisotopic Mass520.1419441 g/mol
    Topological Polar Surface Area93.8 Ų
    Heavy Atom Count35
    Formal Charge0
    Complexity1020
    Isotope Atom Count0
    Defined Atom Stereocenter Count8
    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 6  
    Drug NameElocon
    Drug LabelELOCON (mometasone furoate) Ointment, 0.1% contains mometasone furoate for topical use. Mometasone furoate is a synthetic corticosteroid with anti-inflammatory activity.Chemically, mometasone furoate is 9,21-dichloro-11,17-dihydroxy-16-methylpr...
    Active IngredientMometasone furoate
    Dosage FormLotion; Ointment; Cream
    RouteTopical
    Strength0.1%
    Market StatusPrescription
    CompanyMerck Sharp Dohme

    2 of 6  
    Drug NameMometasone furoate
    PubMed HealthMometasone
    Drug ClassesAnti-Inflammatory, Corticosteroid, Strong
    Drug LabelMometasone furoate, the active component of the ASMANEX TWISTHALER product, is a corticosteroid with the chemical name 9,21-dichloro-11(Beta),17-dihydroxy-16(alpha)-methylpregna-1,4-diene-3,20-dione 17-(2-furoate) and the following chemical structure...
    Active IngredientMometasone furoate
    Dosage FormOintment; Cream; Lotion
    RouteTopical
    Strength0.1%
    Market StatusPrescription
    CompanyTaro; Glenmark Generics; Fougera Pharms; Perrigo; Perrigo New York; Tolmar; G And W Labs

    3 of 6  
    Drug NameNasonex
    Drug LabelMometasone furoate monohydrate, the active component of NASONEX Nasal Spray, 50 mcg, is an anti-inflammatory corticosteroid having the chemical name, 9,21-Dichloro-11,17-dihydroxy-16-methylpregna-1,4-diene-3,20-dione17-(2 furoate) monohydrate, an...
    Active IngredientMometasone furoate monohydrate
    Dosage FormSpray, metered
    RouteNasal
    Strengtheq 0.05mg base/spray
    Market StatusPrescription
    CompanyMerck Sharp Dohme

    4 of 6  
    Drug NameElocon
    Drug LabelELOCON (mometasone furoate) Ointment, 0.1% contains mometasone furoate for topical use. Mometasone furoate is a synthetic corticosteroid with anti-inflammatory activity.Chemically, mometasone furoate is 9,21-dichloro-11,17-dihydroxy-16-methylpr...
    Active IngredientMometasone furoate
    Dosage FormLotion; Ointment; Cream
    RouteTopical
    Strength0.1%
    Market StatusPrescription
    CompanyMerck Sharp Dohme

    5 of 6  
    Drug NameMometasone furoate
    PubMed HealthMometasone
    Drug ClassesAnti-Inflammatory, Corticosteroid, Strong
    Drug LabelMometasone furoate, the active component of the ASMANEX TWISTHALER product, is a corticosteroid with the chemical name 9,21-dichloro-11(Beta),17-dihydroxy-16(alpha)-methylpregna-1,4-diene-3,20-dione 17-(2-furoate) and the following chemical structure...
    Active IngredientMometasone furoate
    Dosage FormOintment; Cream; Lotion
    RouteTopical
    Strength0.1%
    Market StatusPrescription
    CompanyTaro; Glenmark Generics; Fougera Pharms; Perrigo; Perrigo New York; Tolmar; G And W Labs

    6 of 6  
    Drug NameNasonex
    Drug LabelMometasone furoate monohydrate, the active component of NASONEX Nasal Spray, 50 mcg, is an anti-inflammatory corticosteroid having the chemical name, 9,21-Dichloro-11,17-dihydroxy-16-methylpregna-1,4-diene-3,20-dione17-(2 furoate) monohydrate, an...
    Active IngredientMometasone furoate monohydrate
    Dosage FormSpray, metered
    RouteNasal
    Strengtheq 0.05mg base/spray
    Market StatusPrescription
    CompanyMerck Sharp Dohme

    4.2 Drug Indication

    There are 3 formulations of mometasone furoate with various indications. The inhaler is indicated for prophylaxis of asthma in patients 4 years. The nasal spray is indicated for treating nasal symptoms of allergic rhinitis in patients 2 years, treating symptoms of nasal congestion from seasonal allergic rhinitis in patients 2 years, treating nasal polyps in patients 18 years, and prophylaxis of seasonal allergic rhinitis in patients 12 years. The ointment is indicated for symptomatic treatment of dermatitis and pruritis in patients 2 years.

    FDA Label

    Seasonal and perennial allergic rhinitis

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Mometasone is a synthetic corticosteroid with an affinity for glucocorticoid receptors 22 times higher than that of [dexamethasone]. Mometasone furoate also has a lower affinity to mineralocorticoid receptors than natural corticosteroids, making it more selective in its action. Mometasone furoate diffuses across cell membranes to activate pathways responsible for reducing inflammation.

    5.2 MeSH Pharmacological Classification

    Anti-Inflammatory Agents

    Substances that reduce or suppress INFLAMMATION. (See all compounds classified as Anti-Inflammatory Agents.)

    Dermatologic Agents

    Drugs used to treat or prevent skin disorders or for the routine care of skin. (See all compounds classified as Dermatologic Agents.)

    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.)

    5.3 FDA Pharmacological Classification
    5.3.1 Pharmacological Classes
    Corticosteroid Hormone Receptor Agonists [MoA]; Corticosteroid [EPC]; Corticosteroid Hormone Receptor Agonists [MoA]
    5.4 Absorption, Distribution and Excretion

    Absorption

    The mean time to peak concentration is 1.0 to 2.5 hours. Bioavailability has been reported as <1% but studies of repeat doses of inhaled corticosteroids suggest a bioavailability of 11%. The 0.1% ointment may have a bioavailability of 0.7%.

    Route of Elimination

    For an inhaled dose, approximately 74% is excreted in the feces and 8% is excreted in the urine.

    Volume of Distribution

    Steady state volume of distribution of 152L.

    Clearance

    The clearance rate of mometasone furoate is not readily available, though it may be close to 90L/h.

    5.5 Metabolism/Metabolites

    Metabolism of mometasone furoate is largely performed hepatically by cytochrome P450 3A4 producing a number of metabolites. Some of these metabolites include free mometasone and 6-beta-hydroxy-mometasone furoate.

    5.6 Biological Half-Life

    The terminal half life of an inhaled dose is approximately 5 hours though it has been reported as 5.8 hours by other sources.

    5.7 Mechanism of Action

    In asthma, mometasone is believed to inhibit mast cells, eosinophils, basophils, and lymphocytes. There is also evidence of inhibition of histamine, leukotrienes, and cytokines. Corticosteroids diffuse across cell membranes into the cytosol of cells where they bind to glucocorticoid receptors to produce their activity. Mometasone furoate has a particularly high receptor affinity compare to other corticosteroids, 22 times higher than that of [dexamethasone]. Mometasone furoate binding to a glucocorticoid receptor causes conformational changes in the receptor, separation from chaperones, and the receptor moves to the nucleus. Once at the nucleus, receptors dimerize and bind to a DNA sequence known as the glucocorticoid response element which either increases expression of anti-inflammatory molecules or inhibits expression of pro-inflammatory molecules (such as interleukins 4 and 5). Mometasone furoate also reduces inflammation by blocking transcription factors such as activator-protein-1 and nuclear factor kappa B (NF-kappaB).

    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - OINTMENT;TOPICAL - 0.1%

    USFDA APPLICATION NUMBER - 19543

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    DOSAGE - CREAM;TOPICAL - 0.1% **Federal Regis...DOSAGE - CREAM;TOPICAL - 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 19625

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    DOSAGE - LOTION;TOPICAL - 0.1% **Federal Regi...DOSAGE - LOTION;TOPICAL - 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 19796

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    DOSAGE - AEROSOL, METERED;INHALATION - 0.05MG...DOSAGE - AEROSOL, METERED;INHALATION - 0.05MG/INH

    USFDA APPLICATION NUMBER - 205641

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    DOSAGE - AEROSOL, METERED;INHALATION - 0.10MG...DOSAGE - AEROSOL, METERED;INHALATION - 0.10MG/INH

    USFDA APPLICATION NUMBER - 205641

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    DOSAGE - AEROSOL, METERED;INHALATION - 0.20MG...DOSAGE - AEROSOL, METERED;INHALATION - 0.20MG/INH

    USFDA APPLICATION NUMBER - 205641

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    DOSAGE - SPRAY, METERED;NASAL - 0.05MG/SPRAY ...DOSAGE - SPRAY, METERED;NASAL - 0.05MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20762

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    DOSAGE - POWDER;INHALATION - 0.11MG/INH

    USFDA APPLICATION NUMBER - 21067

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    DOSAGE - POWDER;INHALATION - 0.22MG/INH

    USFDA APPLICATION NUMBER - 21067

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    DOSAGE - AEROSOL, METERED;INHALATION - 0.005M...DOSAGE - AEROSOL, METERED;INHALATION - 0.005MG/INH;0.05MG/INH

    USFDA APPLICATION NUMBER - 22518

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    DOSAGE - AEROSOL, METERED;INHALATION - 0.005M...DOSAGE - AEROSOL, METERED;INHALATION - 0.005MG/INH;0.1MG/INH

    USFDA APPLICATION NUMBER - 22518

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    DOSAGE - AEROSOL, METERED;INHALATION - 0.005M...DOSAGE - AEROSOL, METERED;INHALATION - 0.005MG/INH;0.2MG/INH

    USFDA APPLICATION NUMBER - 22518

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    ABOUT THIS PAGE

    Looking for 83919-23-7 / Mometasone Furoate API manufacturers, exporters & distributors?

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    API | Excipient name

    Mometasone Furoate

    Synonyms

    83919-23-7, Asmanex, Nasonex, Elocon, Monovo, Sch 32088

    Cas Number

    83919-23-7

    Unique Ingredient Identifier (UNII)

    04201GDN4R

    About Mometasone Furoate

    A pregnadienediol derivative ANTI-ALLERGIC AGENT and ANTI-INFLAMMATORY AGENT that is used in the management of ASTHMA and ALLERGIC RHINITIS. It is also used as a topical treatment for skin disorders.

    Rimelon Manufacturers

    A Rimelon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rimelon, including repackagers and relabelers. The FDA regulates Rimelon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rimelon API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

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    Rimelon Suppliers

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

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

    Rimelon USDMF

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

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

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

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

    Rimelon KDMF

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

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

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

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

    Rimelon CEP

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

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

    Rimelon WC

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

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

    Rimelon 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 Rimelon as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Rimelon GMP

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

    Rimelon CoA

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

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

    Rimelon may be tested according to a variety of international standards, such as European Pharmacopoeia (Rimelon EP), Rimelon JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rimelon 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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    • Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.

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