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    Chemistry

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    Also known as: 106685-40-9, Differin, Adapaleno, 6-(3-(adamantan-1-yl)-4-methoxyphenyl)-2-naphthoic acid, Adapalenum, Adapalenum [inn-latin]
    Molecular Formula
    C28H28O3
    Molecular Weight
    412.5  g/mol
    InChI Key
    LZCDAPDGXCYOEH-UHFFFAOYSA-N
    FDA UNII
    1L4806J2QF
    Adapalene
    A naphthalene derivative that has specificity for RETINOIC ACID RECEPTORS. It is used as a DERMATOLOGIC AGENT for the treatment of ACNE.
    Adapalene is a Retinoid.
    1 2D Structure

    Adapalene

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    6-[3-(1-adamantyl)-4-methoxyphenyl]naphthalene-2-carboxylic acid
    2.1.2 InChI
    InChI=1S/C28H28O3/c1-31-26-7-6-23(21-2-3-22-12-24(27(29)30)5-4-20(22)11-21)13-25(26)28-14-17-8-18(15-28)10-19(9-17)16-28/h2-7,11-13,17-19H,8-10,14-16H2,1H3,(H,29,30)
    2.1.3 InChI Key
    LZCDAPDGXCYOEH-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    COC1=C(C=C(C=C1)C2=CC3=C(C=C2)C=C(C=C3)C(=O)O)C45CC6CC(C4)CC(C6)C5
    2.2 Other Identifiers
    2.2.1 UNII
    1L4806J2QF
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 271, Cd

    2. 6-(3-(1-adamantyl)-4-methoxyphenyl)-2-naphthoic Acid

    3. Adaferin

    4. Cd 271

    5. Cd-271

    6. Cd271

    7. Differin

    8. Differine

    2.3.2 Depositor-Supplied Synonyms

    1. 106685-40-9

    2. Differin

    3. Adapaleno

    4. 6-(3-(adamantan-1-yl)-4-methoxyphenyl)-2-naphthoic Acid

    5. Adapalenum

    6. Adapalenum [inn-latin]

    7. Adapaleno [inn-spanish]

    8. Cd 271

    9. Cd-271

    10. 6-[3-(1-adamantyl)-4-methoxyphenyl]naphthalene-2-carboxylic Acid

    11. 6-(3-(1-adamantyl)-4-methoxyphenyl)-2-naphthoic Acid

    12. 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic Acid

    13. Mfcd03106112

    14. 6-[3-(1-adamantyl)-4-methoxy-phenyl]naphthalene-2-carboxylic Acid

    15. Chembl1265

    16. 6-(4-methoxy-3-tricyclo[3.3.1.13,7]dec-1-ylphenyl)-2-naphthalenecarboxylic Acid

    17. Adaferin

    18. Chebi:31174

    19. 1l4806j2qf

    20. 6-(3-adamantan-1-yl-4-methoxyphenyl)naphthalene-2-carboxylic Acid

    21. Ncgc00164617-01

    22. Adapalen

    23. Differine

    24. 6-[3-(adamantan-1-yl)-4-methoxyphenyl]naphthalene-2-carboxylic Acid

    25. 2-naphthalenecarboxylic Acid, 6-(4-methoxy-3-tricyclo(3.3.1.1(sup 3,7))dec-1-ylphenyl)-

    26. Dsstox_cid_26481

    27. Dsstox_rid_81652

    28. Dsstox_gsid_46481

    29. Differin Gel

    30. Cd271

    31. Differin (tn)

    32. Cas-106685-40-9

    33. Differin Gel 0.1%

    34. Adapalene [usan:inn:ban]

    35. Unii-1l4806j2qf

    36. Adapalene- Bio-x

    37. Ks-1196

    38. Adapalene [inn]

    39. Adapalene [jan]

    40. Adapalene [mi]

    41. Adapalene [usan]

    42. Adapalene [vandf]

    43. Adapalene [mart.]

    44. Adapalene [usp-rs]

    45. Adapalene [who-dd]

    46. Schembl2747

    47. Adapalene (jan/usp/inn)

    48. Mls000759463

    49. Mls006010036

    50. Bidd:gt0264

    51. Idp-126 Component Adapalene

    52. Gtpl5429

    53. Adapalene [orange Book]

    54. Adapalene [ep Monograph]

    55. Adapalene, >=98% (hplc)

    56. Chembl4303650

    57. Dtxsid5046481

    58. Epiduo Component Adapalene

    59. Adapalene [usp Monograph]

    60. Hms3264f15

    61. Hms3654f11

    62. Hms3715h16

    63. Bcp02081

    64. Hy-b0091

    65. Zinc3784182

    66. Adapalene Component Of Epiduo

    67. Tox21_112236

    68. Bdbm50048280

    69. S1276

    70. Stl453114

    71. Akos005145841

    72. Akos015895391

    73. Tox21_112236_1

    74. Ab13763

    75. Ac-1974

    76. Bcp9000231

    77. Ccg-213060

    78. Ccg-221237

    79. Cs-1789

    80. Db00210

    81. Ncgc00164617-02

    82. Ncgc00164617-04

    83. Ncgc00164617-05

    84. Ba164138

    85. Smr000466349

    86. Smr002529673

    87. Sy009767

    88. A2549

    89. Ft-0631040

    90. Sw219282-1

    91. D01112

    92. Ab01274764-01

    93. Ab01274764-02

    94. Ab01274764_03

    95. Ab01274764_04

    96. 685a409

    97. A801483

    98. Q352348

    99. Sr-01000942194

    100. Sr-01000942194-2

    101. 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoicacid

    102. Brd-k33127281-001-01-5

    103. F2173-0588

    104. 6-(3-(adamantan-1-yl)-4-methoxyphenyl)-2-naphthoicacid

    105. Adapalene 100 Microg/ml In Acetonitrile:dimethylsulfoxide

    106. Adapalene, European Pharmacopoeia (ep) Reference Standard

    107. Adapalene, United States Pharmacopeia (usp) Reference Standard

    108. 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthalene-carboxylic Acid

    109. 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthalenecarboxylic Acid

    110. 6-(3-((3r,5r,7r)-adamantan-1-yl)-4-methoxyphenyl)-2-naphthoic Acid

    111. Adapalene, Pharmaceutical Secondary Standard; Certified Reference Material

    112. 6-[3-(1-adamantyl)-4-methoxy-phenyl]naphthalene-2-carboxylic Acid;adapalene

    113. 6-[4-methoxy-3-(tricyclo[3.3.1.1~3,7~]dec-1-yl)phenyl]naphthalene-2-carboxylic Acid

    114. 6-[4-methoxy-3-(tricyclo[3.3.1.13,7]dec-1-yl)phenyl]naphthalene-2-carboxylic Acid

    115. Adapalene For Peak Identification, European Pharmacopoeia (ep) Reference Standard

    116. 2-naphthalenecarboxylic Acid, 6-(4-methoxy-3-tricyclo(3.3.1.(sup 13,7))dec-1-ylphenyl)-

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 412.5 g/mol
    Molecular Formula C28H28O3
    XLogP37.7
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count3
    Rotatable Bond Count4
    Exact Mass412.20384475 g/mol
    Monoisotopic Mass412.20384475 g/mol
    Topological Polar Surface Area46.5 Ų
    Heavy Atom Count31
    Formal Charge0
    Complexity645
    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 NameAdapalene
    PubMed HealthAdapalene (On the skin)
    Drug ClassesAntiacne
    Drug LabelAdapalene Gel, containing adapalene, is used for the topical treatment of acne vulgaris. Each gram of Adapalene Gel contains adapalene 0.1% (1 mg) in a vehicle consisting of carbomer homopolymer type C, disodium edetate, methylparaben, poloxamer 182,...
    Active IngredientAdapalene
    Dosage FormGel; Cream
    Routetopical; Topical
    Strength0.3%; 0.1%
    Market StatusTentative Approval; Prescription
    CompanyGlenmark Generics; Fougera Pharms; Actavis Mid Atlantic; Pliva Hrvatska Doo; Tolmar

    2 of 4  
    Drug NameDifferin
    PubMed HealthAdapalene (On the skin)
    Drug ClassesAntiacne
    Drug LabelDIFFERIN Gel, containing adapalene, is used for the topical treatment of acne vulgaris. Each gram of DIFFERIN Gel contains adapalene 0.1% (1 mg) in a vehicle consisting of carbomer 940, edetate disodium, methylparaben, poloxamer 182, propylene glyc...
    Active IngredientAdapalene
    Dosage FormLotion; Gel; Cream
    RouteTopical
    Strength0.3%; 0.1%
    Market StatusPrescription
    CompanyGalderma Labs

    3 of 4  
    Drug NameAdapalene
    PubMed HealthAdapalene (On the skin)
    Drug ClassesAntiacne
    Drug LabelAdapalene Gel, containing adapalene, is used for the topical treatment of acne vulgaris. Each gram of Adapalene Gel contains adapalene 0.1% (1 mg) in a vehicle consisting of carbomer homopolymer type C, disodium edetate, methylparaben, poloxamer 182,...
    Active IngredientAdapalene
    Dosage FormGel; Cream
    Routetopical; Topical
    Strength0.3%; 0.1%
    Market StatusTentative Approval; Prescription
    CompanyGlenmark Generics; Fougera Pharms; Actavis Mid Atlantic; Pliva Hrvatska Doo; Tolmar

    4 of 4  
    Drug NameDifferin
    PubMed HealthAdapalene (On the skin)
    Drug ClassesAntiacne
    Drug LabelDIFFERIN Gel, containing adapalene, is used for the topical treatment of acne vulgaris. Each gram of DIFFERIN Gel contains adapalene 0.1% (1 mg) in a vehicle consisting of carbomer 940, edetate disodium, methylparaben, poloxamer 182, propylene glyc...
    Active IngredientAdapalene
    Dosage FormLotion; Gel; Cream
    RouteTopical
    Strength0.3%; 0.1%
    Market StatusPrescription
    CompanyGalderma Labs

    4.2 Drug Indication

    Adapalene is indicated for the topical treatment of acne vulgaris in patients aged 12 and over.

    FDA Label

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Adapalene is anticomedogenic, preventing the formation of new comedones and inflammatory lesions, and also acts to reduce inflammation by modulating the innate immune response. Like other retinoid compounds, adapalene is chemically stable but photosensitive; use with sunscreen is recommended. Minor skin irritations, including erythema, scaling, dryness, and stinging/burning, have been reported.

    5.2 MeSH Pharmacological Classification

    Anti-Inflammatory Agents, Non-Steroidal

    Anti-inflammatory agents that are non-steroidal in nature. In addition to anti-inflammatory actions, they have analgesic, antipyretic, and platelet-inhibitory actions. They act by blocking the synthesis of prostaglandins by inhibiting cyclooxygenase, which converts arachidonic acid to cyclic endoperoxides, precursors of prostaglandins. Inhibition of prostaglandin synthesis accounts for their analgesic, antipyretic, and platelet-inhibitory actions; other mechanisms may contribute to their anti-inflammatory effects. (See all compounds classified as Anti-Inflammatory Agents, Non-Steroidal.)

    Dermatologic Agents

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

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    ADAPALENE
    5.3.2 FDA UNII
    1L4806J2QF
    5.3.3 Pharmacological Classes
    Retinoids [CS]; Retinoid [EPC]
    5.4 ATC Code

    D10AD03

    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

    D - Dermatologicals

    D10 - Anti-acne preparations

    D10A - Anti-acne preparations for topical use

    D10AD - Retinoids for topical use in acne

    D10AD03 - Adapalene

    5.5 Absorption, Distribution and Excretion

    Absorption

    Adapalene is applied topically and absorbed through the skin. In one clinical study treating patients once per day with 2g of 0.3% gel applied to 2 mg/cm2 of skin, 15 patients had detectable blood plasma adapalene levels (0.1 ng/ml) resulting in a mean Cmax of 0.553 0.466 ng/ml and a mean AUC of 8.37 8.46 ng\*h/ml on day 10.

    Route of Elimination

    Adapalene is primarily excreted by the biliary route at about 30 ng/g of the topically applied amount. Approximately 75% of the drug remains unchanged.

    Clearance

    Adapalene is rapidly cleared from blood plasma, typically undetectable after 72 hours following topical application.

    5.6 Metabolism/Metabolites

    Extensive information regarding adapalene metabolism in humans is unavailable, although it is known to accumulate in the liver and GI-tract. In human, mouse, rat, rabbit, and dog cultured hepatocytes, metabolism appears to affect the methoxybenzene moiety but remains incompletely characterized. The major products of metabolism are glucuronides. Approximately 25% of the drug is metabolized; the rest is excreted as parent drug.

    5.7 Biological Half-Life

    In one clinical study, after ten days of treatment with 2g of 0.3% cream or gel, the terminal half-life was between 7 and 51 hours, with a mean of 17.2 10.2.

    5.8 Mechanism of Action

    Adapalene is used for the treatment/maintenance of mild-to-severe acne (acne vulgaris). Acne is a multifactorial condition, and evidence exists to support multiple mechanisms of action for adapalene. Adapalene binds to retinoic acid receptor (RAR)-beta and RAR-gamma; this complex subsequently binds to one of three retinoid X receptors (RXRs), which as a complex is capable of binding DNA to modulate transcriptional activity. Although the full extent of transcriptional modulation is not described, retinoid activation is generally known to affect cellular proliferation and differentiation, and adapalene has been shown to inhibit HeLa cell proliferation and human keratinocyte differentiation. These effects primarily account for adapalene's comedolytic and anticomedogenic properties. In addition, adapalene modulates the immune response by down-regulating toll-like receptor 2 (TLR-2) expression and inhibiting the transcription factor activator protein 1 (AP-1). TLR-2 recognizes _Cutibacterium acnes_ (formerly _Propionibacterium acnes_), the bacterium primarily associated with acne. TLR-2 activation causes nuclear translocation of AP-1 and downstream pro-inflammatory gene regulation. Therefore, adapalene has a general anti-inflammatory effect, which reduces inflammation-mediated acne symptoms. When used with benzoyl peroxide, which possesses free radical-mediated bactericidal effects, the combination acts synergistically to reduced comedones and inflammatory lesions.

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LIMITED","customerCountry":"INDIA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"11000","totalValueFC":"55573.6","currency":"USD","unitRateINR":"927850","date":"01-Jun-2024","totalValueINR":"4639250","totalValueInUsd":"55573.6","indian_port":"Bombay Air","hs_no":"29189990","bill_no":"3785780","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"FRUCTUOS GELABERT,6-808970 SANT JOAN DESPI BARCELONASDNF ES","customerAddress":"UNIT NO.24 STEEL MADE INDL.ESTATE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1717698600,"product":"ADAPALENE MICRO EP\/USP","address":"UNIT NO.24 STEEL MADE INDL.ESTATE","city":"MUMBAI","supplier":"OLON S.P.A","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"ENCUBE ETHICALS PRIVATE LIMITED","customerCountry":"INDIA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"11000","totalValueFC":"55540.6","currency":"USD","unitRateINR":"927300","date":"07-Jun-2024","totalValueINR":"4636500","totalValueInUsd":"55540.6","indian_port":"Bombay Air","hs_no":"29189990","bill_no":"3874389","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"DIREZIONE E UFFICI STRRIVOLTANA KM 6\/7RODANO (Ml) IT","customerAddress":"UNIT NO.24 STEEL MADE INDL.ESTATE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728585000,"product":"ADAPALENE MICRO EP\/USP","address":"UNIT NO.24 STEEL MADE INDL.ESTATE","city":"MUMBAI","supplier":"OLON S.P.A","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"ENCUBE ETHICALS PRIVATE LIMITED","customerCountry":"INDIA","quantity":"1.50","actualQuantity":"1.5","unit":"KGS","unitRateFc":"11000","totalValueFC":"16661.7","currency":"USD","unitRateINR":"933350","date":"11-Oct-2024","totalValueINR":"1400025","totalValueInUsd":"16661.7","indian_port":"Bombay Air","hs_no":"29189990","bill_no":"6080962","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"DIREZIONE E UFFICI STR RIVOLTANA KM 6\/7 RODANO (Ml) IT","customerAddress":"UNIT NO.24 STEEL MADE INDL.ESTATE"}]
    01-Jan-2021
    31-Dec-2024
    KGS
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    Average Price (USD/KGS)

    Number of Transactions

    Total Quantity (KGS)

    Total Value (USD)

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

    API Imports and Exports

    Importing Country Total Quantity
    (KGS)    		 Average Price
    (USD/KGS)    		 Number of Transactions

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - GEL;TOPICAL - 0.1%

    USFDA APPLICATION NUMBER - 20380

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    DOSAGE - GEL;TOPICAL - 0.3%

    USFDA APPLICATION NUMBER - 21753

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    DOSAGE - LOTION;TOPICAL - 0.1%

    USFDA APPLICATION NUMBER - 22502

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    01

    Brand Name : Adapalene

    Country
    arrow
    The Generic Rx Session
    Not Confirmed

    Brand Name : Adapalene

    Country
    arrow
    The Generic Rx Session
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Company :

    Adapalene

    Drug Cost (USD) : 4,363,057

    Year : 2022

    Prescribers : 4037

    Prescriptions : 8476

    blank

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    02

    Brand Name : Differin

    Country
    arrow
    The Generic Rx Session
    Not Confirmed

    Brand Name : Differin

    Country
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    The Generic Rx Session
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Company :

    Adapalene

    Drug Cost (USD) : 111,263

    Year : 2022

    Prescribers : 162

    Prescriptions : 290

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    03

    Brand Name : Adapalene

    Country
    arrow
    The Generic Rx Session
    Not Confirmed

    Brand Name : Adapalene

    Country
    arrow
    The Generic Rx Session
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Company :

    Adapalene

    Drug Cost (USD) : 2,559,551

    Year : 2021

    Prescribers : 5495

    Prescriptions : 11954

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    04

    Brand Name : Differin

    Country
    arrow
    The Generic Rx Session
    Not Confirmed

    Brand Name : Differin

    Country
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    The Generic Rx Session
    Not Confirmed
    • fda
    • EDQM
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    Company :

    Adapalene

    Drug Cost (USD) : 123,488

    Year : 2021

    Prescribers : 153

    Prescriptions : 297

    blank

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    Website

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    05

    Brand Name : Epiduo

    Country
    arrow
    The Generic Rx Session
    Not Confirmed

    Brand Name : Epiduo

    Country
    arrow
    The Generic Rx Session
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Company :

    Adapalene/Benzoyl Peroxide

    Drug Cost (USD) : 12,052

    Year : 2020

    Prescribers : 13

    Prescriptions : 30

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    06

    Brand Name : Differin

    Country
    arrow
    The Generic Rx Session
    Not Confirmed

    Brand Name : Differin

    Country
    arrow
    The Generic Rx Session
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Company :

    Adapalene

    Drug Cost (USD) : 140,908

    Year : 2020

    Prescribers : 167

    Prescriptions : 311

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    07

    Brand Name : Adapalene

    Country
    arrow
    The Generic Rx Session
    Not Confirmed

    Brand Name : Adapalene

    Country
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    The Generic Rx Session
    Not Confirmed
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    Company :

    Adapalene

    Drug Cost (USD) : 2,053,632

    Year : 2020

    Prescribers : 5885

    Prescriptions : 12808

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    08

    Brand Name : Adapalene

    Country
    arrow
    The Generic Rx Session
    Not Confirmed

    Brand Name : Adapalene

    Country
    arrow
    The Generic Rx Session
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Company :

    Adapalene

    Drug Cost (USD) : 1,781,632

    Year : 2019

    Prescribers : 5580

    Prescriptions : 12295

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    09

    Brand Name : Adapalene-Benzoyl Peroxide

    Country
    arrow
    The Generic Rx Session
    Not Confirmed

    Brand Name : Adapalene-Benzoyl Peroxide

    Country
    arrow
    The Generic Rx Session
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Company :

    Adapalene/Benzoyl Peroxide

    Drug Cost (USD) : 131,161

    Year : 2019

    Prescribers : 693

    Prescriptions : 1194

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    10

    Brand Name : Differin

    Country
    arrow
    The Generic Rx Session
    Not Confirmed

    Brand Name : Differin

    Country
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    The Generic Rx Session
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Company :

    Adapalene

    Drug Cost (USD) : 123,594

    Year : 2019

    Prescribers : 187

    Prescriptions : 342

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    Website

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    Finished Drug Prices

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    01

    Brand Name : Differin

    Switzerland
    arrow
    BioAsia
    Not Confirmed

    Brand Name : Differin

    Switzerland
    arrow
    BioAsia
    Not Confirmed

    GALDERMA ITALIA SpA

    Adapalene

    Dosage Form :

    Dosage Strength : Cream 50 G 0,1 %  

    Price Per Pack (Euro) : 30.09

    Published in :

    Country : Italy

    RX/OTC/DISCN : Class C

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    02

    Brand Name : Differin

    Switzerland
    arrow
    BioAsia
    Not Confirmed

    Brand Name : Differin

    Switzerland
    arrow
    BioAsia
    Not Confirmed

    GALDERMA ITALIA SpA

    Adapalene

    Dosage Form :

    Dosage Strength : The Gel 50 G 0,1 %  

    Price Per Pack (Euro) : 30.09

    Published in :

    Country : Italy

    RX/OTC/DISCN : Class C

    blank

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    03

    Brand Name : Differin

    Switzerland
    arrow
    BioAsia
    Not Confirmed

    Brand Name : Differin

    Switzerland
    arrow
    BioAsia
    Not Confirmed

    GALDERMA ITALIA SpA

    Adapalene

    Dosage Form :

    Dosage Strength : Cream Derm 30 G 0,1%  

    Price Per Pack (Euro) : 23.97

    Published in :

    Country : Italy

    RX/OTC/DISCN : Class C

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    04

    Brand Name : Differin

    Switzerland
    arrow
    BioAsia
    Not Confirmed

    Brand Name : Differin

    Switzerland
    arrow
    BioAsia
    Not Confirmed

    GALDERMA ITALIA SpA

    Adapalene

    Dosage Form :

    Dosage Strength : Gel 30 G 0,1%  

    Price Per Pack (Euro) : 23.97

    Published in :

    Country : Italy

    RX/OTC/DISCN : Class C

    blank

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    05

    Brand Name : Epiduo

    Switzerland
    arrow
    BioAsia
    Not Confirmed

    Brand Name : Epiduo

    Switzerland
    arrow
    BioAsia
    Not Confirmed

    GALDERMA ITALIA SpA

    Benzoyl Peroxide; Adapalene

    Dosage Form :

    Dosage Strength : Gel 30 G 0.1% + 2.5%

    Price Per Pack (Euro) : 29.9

    Published in :

    Country : Italy

    RX/OTC/DISCN : Class C

    blank

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    06

    Brand Name : Erin Diff

    Switzerland
    arrow
    BioAsia
    Not Confirmed

    Brand Name : Erin Diff

    Switzerland
    arrow
    BioAsia
    Not Confirmed

    Galderma Nordic AB

    Adapalene

    Dosage Form : Cream

    Dosage Strength : 1 mg/g

    Price Per Pack (Euro) : 17.853

    Published in :

    Country : Norway

    RX/OTC/DISCN :

    blank

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    07

    Brand Name : Differin

    Switzerland
    arrow
    BioAsia
    Not Confirmed

    Brand Name : Differin

    Switzerland
    arrow
    BioAsia
    Not Confirmed

    Galderma SA

    Adapalene

    Dosage Form : Cream

    Dosage Strength :

    Price Per Pack (Euro) : 12.79

    Published in :

    Country : Switzerland

    RX/OTC/DISCN : Class B

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    08

    Brand Name : ADAPALENE

    U.S.A
    arrow
    BioAsia
    Not Confirmed

    Brand Name : ADAPALENE

    U.S.A
    arrow
    BioAsia
    Not Confirmed

    FOUGERA PHARMS

    Adapalene

    Dosage Form : CREAM;TOPICAL

    Dosage Strength : 0.1%

    Price Per Pack :

    Published in :

    Country : USA

    RX/OTC/DISCN : RX

    blank

    Portfolio PDF

    Product Web Link

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    09

    Brand Name : Erin Diff

    Switzerland
    arrow
    BioAsia
    Not Confirmed

    Brand Name : Erin Diff

    Switzerland
    arrow
    BioAsia
    Not Confirmed

    Galderma Nordic AB

    Adapalene

    Dosage Form : Gel

    Dosage Strength : 1 mg/g

    Price Per Pack (Euro) : 17.457

    Published in :

    Country : Norway

    RX/OTC/DISCN :

    blank

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    Product Web Link

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    10

    Brand Name : Epiduo

    Country
    arrow
    BioAsia
    Not Confirmed

    Brand Name : Epiduo

    Country
    arrow
    BioAsia
    Not Confirmed

    2care4

    Adapalene

    Dosage Form : Gel

    Dosage Strength : 0.1%/2.5%

    Price Per Pack (Euro) : 42.471

    Published in :

    Country : Norway

    RX/OTC/DISCN :

    blank

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    Product Web Link

    Virtual Booth

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    Website

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    USP

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    ABOUT THIS PAGE

    Looking for 106685-40-9 / Adapalene API manufacturers, exporters & distributors?

    Adapalene manufacturers, exporters & distributors 1

    46

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

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

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

    API | Excipient name

    Adapalene

    Synonyms

    106685-40-9, Differin, Adapaleno, 6-(3-(adamantan-1-yl)-4-methoxyphenyl)-2-naphthoic acid, Adapalenum, Adapalenum [inn-latin]

    Cas Number

    106685-40-9

    Unique Ingredient Identifier (UNII)

    1L4806J2QF

    About Adapalene

    A naphthalene derivative that has specificity for RETINOIC ACID RECEPTORS. It is used as a DERMATOLOGIC AGENT for the treatment of ACNE.

    Adapalene Manufacturers

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

    Adapalene Suppliers

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

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

    Adapalene USDMF

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

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

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

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

    Adapalene KDMF

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

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

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

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

    Adapalene CEP

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

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

    Adapalene WC

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

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

    Adapalene 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 Adapalene as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Adapalene GMP

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

    Adapalene CoA

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

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

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