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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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Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete sourcing solutions for pharmaceutical products from India, including technical and regulatory assistance. It believes in providing its customers with high-quality products at reasonable prices. It has always endeavored to achieve global standards in the field of pharmaceuticals and has carved out a niche for itself through new methods based on current market needs. Today, it has established itself as a truly global company, with exports to almost every continent.
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Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, corticosteroids, cytotoxic & oncology products. It has 2 R&D centers & 3 cGMP plants successfully audited by the USFDA, EUGMP, EDQM, KFDA & COFEPRIS. It offers CDMO services for generic APIs & NCEs, intermediates & key building blocks.Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer
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Adapalene

About the Company : ​Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological API...

​Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square meters of R&D centers in Nantong, Jiangsu and Jinan, Shandong, with more than 13,000㎡ of production sites. While supplying products to customers, the company also provides services such as technology development, technology transfer and technology exchange, aiming to provide customers with comprehensive supply and solutions in the biomedical industry.
Shanghai Minbiotech CB

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Virtual BoothTenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.

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Adapalene

About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...

Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opportunities grew, it was felt that the proprietorship firm had outlived its usefulness and that it needed a corporate structure. So, Tenatra Exports Private Limited was incorporated in 2002. Since then, the company has come a long way, gaining valuable experience and knowledge in the fields of chemicals and pharmaceuticals in India.
Tenatra

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Virtual BoothDelivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.

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Adapalene

About the Company : Zeal MediPharma is a globally recognized Star One Export House, serving customers in over 50 countries for more than two decades. We specialize in sourcing and exporting high-quali...

Zeal MediPharma is a globally recognized Star One Export House, serving customers in over 50 countries for more than two decades. We specialize in sourcing and exporting high-quality APIs for human and veterinary use, along with drug intermediates, excipients, and semi-finished formulations such as pellets and DC granules. Our diverse portfolio also includes herbal extracts, phytochemicals, nutraceuticals, food and feed ingredients, agrochemicals, preservatives, surfactants, and specialty chemicals. Committed to excellence, we deliver reliable, high-quality solutions to meet the evolving needs of global healthcare and industry.
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Virtual BoothMaithri Drugs: Dedicated to your API needs.

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Adapalene

About the Company : Maithri Drugs Pvt. Ltd. is a trusted global partner in Active Pharmaceutical Ingredients (APIs), supplying to pharmaceutical leaders in 60+ countries. With APIs spanning antivirals...

Maithri Drugs Pvt. Ltd. is a trusted global partner in Active Pharmaceutical Ingredients (APIs), supplying to pharmaceutical leaders in 60+ countries. With APIs spanning antivirals, antibiotics, ARVs, CNS, and cardiovascular segments, we deliver innovation with reliability. Our facilities are approved by US FDA, EDQM, Health Canada, and WHO-GMP, backed by numerous global DMFs and recognition as an Ecovadis-rated company. Supported by strong R&D, global patents, and customer-centric practices, Maithri ensures world-class APIs with regulatory excellence and exceptional service.
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Adapalene

About the Company : Aspire group was established in the year 2000 with a motto of quality drug for better health of all. In its journey till date, aspire has developed enormous reputation, consistent ...

Aspire group was established in the year 2000 with a motto of quality drug for better health of all. In its journey till date, aspire has developed enormous reputation, consistent growth, unique technologies and world class quality healthcare products. Aspire is pioneer in manufacturing and sourcing unique healthcare products. True to the statement, “Where the future started yesterday” with a foresight on the current trends in the healthcare market, Aspire has grown from strength combining its research strength, Human resources and well established quality systems. Aspire has crossed numerous milestones in a comparatively short period since its inception.
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Adapalene

About the Company : Darou Pakhsh Pharma Chem (DPPC Co.) as one of the qualified and leading producers of active pharmaceutical ingredients in the Iranian pharmaceutical industry started production sin...

Darou Pakhsh Pharma Chem (DPPC Co.) as one of the qualified and leading producers of active pharmaceutical ingredients in the Iranian pharmaceutical industry started production since 1993 with GMP and ISO certificates. Darupakhsh Pharmaceutical Chemistry Company with synthesis departments, clean and GMP spaces , glass line and steel reactors, separate warehouses for storage of raw materials, solvents, intermediates and final product and production units with advanced facilities and equipment at the final level and number 4 GMP dry clean section and quality control laboratory unit
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Adapalene

About the Company : Glenmark was founded with a vision to emerge as a leading integrated research-based, global pharmaceutical company. Our branded generics business has a significant presence in mark...

Glenmark was founded with a vision to emerge as a leading integrated research-based, global pharmaceutical company. Our branded generics business has a significant presence in markets across emerging economies including India. The generics business services the requirements of developed markets like US and Western Europe. Our API business sells products in over 65 countries including the US, various countries in the EU, South America and India. With 15 manufacturing facilities and 3 R&D centers dedicated to the goal of enriching lives across the globe.
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LTD","customerCountry":"INDIA","quantity":"1.20","actualQuantity":"1.2","unit":"KGS","unitRateFc":"11000","totalValueFC":"13311.9","currency":"USD","unitRateINR":"927300","date":"01-Jul-2024","totalValueINR":"1112760","totalValueInUsd":"13311.9","indian_port":"Bombay Air","hs_no":"29189990","bill_no":"4280966","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":"Q3","strtotime":1719772200,"product":"ADAPALENE","address":"UNIT NO.24 STEEL MADE INDL.ESTATE","city":"MUMBAI","supplier":"MEDICHEMSA","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"ENCUBE ETHICALS PRIVATE 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12-Jan-2022
19-Jul-2025
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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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ABOUT THIS PAGE

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

Adapalene manufacturers, exporters & distributors 1

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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.

Differin, Teva, Pimpal, Gallet, Adelene, Adeferin Manufacturers

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

Differin, Teva, Pimpal, Gallet, Adelene, Adeferin Suppliers

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

click here to find a list of Differin, Teva, Pimpal, Gallet, Adelene, Adeferin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Differin, Teva, Pimpal, Gallet, Adelene, Adeferin USDMF

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

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

click here to find a list of Differin, Teva, Pimpal, Gallet, Adelene, Adeferin suppliers with USDMF on PharmaCompass.

Differin, Teva, Pimpal, Gallet, Adelene, Adeferin 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 Differin, Teva, Pimpal, Gallet, Adelene, Adeferin Drug Master File in Japan (Differin, Teva, Pimpal, Gallet, Adelene, Adeferin JDMF) empowers Differin, Teva, Pimpal, Gallet, Adelene, Adeferin 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 Differin, Teva, Pimpal, Gallet, Adelene, Adeferin JDMF during the approval evaluation for pharmaceutical products. At the time of Differin, Teva, Pimpal, Gallet, Adelene, Adeferin 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 Differin, Teva, Pimpal, Gallet, Adelene, Adeferin suppliers with JDMF on PharmaCompass.

Differin, Teva, Pimpal, Gallet, Adelene, Adeferin KDMF

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

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

After submitting a Differin, Teva, Pimpal, Gallet, Adelene, Adeferin 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 Differin, Teva, Pimpal, Gallet, Adelene, Adeferin API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Differin, Teva, Pimpal, Gallet, Adelene, Adeferin suppliers with KDMF on PharmaCompass.

Differin, Teva, Pimpal, Gallet, Adelene, Adeferin CEP

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

A Differin, Teva, Pimpal, Gallet, Adelene, Adeferin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Differin, Teva, Pimpal, Gallet, Adelene, Adeferin 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 Differin, Teva, Pimpal, Gallet, Adelene, Adeferin suppliers with CEP (COS) on PharmaCompass.

Differin, Teva, Pimpal, Gallet, Adelene, Adeferin WC

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

click here to find a list of Differin, Teva, Pimpal, Gallet, Adelene, Adeferin suppliers with Written Confirmation (WC) on PharmaCompass.

Differin, Teva, Pimpal, Gallet, Adelene, Adeferin 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 Differin, Teva, Pimpal, Gallet, Adelene, Adeferin as an active pharmaceutical ingredient (API).

Finished drug products

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

click here to find a list of Differin, Teva, Pimpal, Gallet, Adelene, Adeferin suppliers with NDC on PharmaCompass.

Differin, Teva, Pimpal, Gallet, Adelene, Adeferin GMP

Differin, Teva, Pimpal, Gallet, Adelene, Adeferin 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 Differin, Teva, Pimpal, Gallet, Adelene, Adeferin 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 Differin, Teva, Pimpal, Gallet, Adelene, Adeferin GMP manufacturer or Differin, Teva, Pimpal, Gallet, Adelene, Adeferin GMP API supplier for your needs.

Differin, Teva, Pimpal, Gallet, Adelene, Adeferin CoA

A Differin, Teva, Pimpal, Gallet, Adelene, Adeferin CoA (Certificate of Analysis) is a formal document that attests to Differin, Teva, Pimpal, Gallet, Adelene, Adeferin's compliance with Differin, Teva, Pimpal, Gallet, Adelene, Adeferin specifications and serves as a tool for batch-level quality control.

Differin, Teva, Pimpal, Gallet, Adelene, Adeferin CoA mostly includes findings from lab analyses of a specific batch. For each Differin, Teva, Pimpal, Gallet, Adelene, Adeferin 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.

Differin, Teva, Pimpal, Gallet, Adelene, Adeferin may be tested according to a variety of international standards, such as European Pharmacopoeia (Differin, Teva, Pimpal, Gallet, Adelene, Adeferin EP), Differin, Teva, Pimpal, Gallet, Adelene, Adeferin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Differin, Teva, Pimpal, Gallet, Adelene, Adeferin 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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