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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
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)-
| Molecular Weight | 412.5 g/mol |
|---|---|
| Molecular Formula | C28H28O3 |
| XLogP3 | 7.7 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 3 |
| Rotatable Bond Count | 4 |
| Exact Mass | 412.20384475 g/mol |
| Monoisotopic Mass | 412.20384475 g/mol |
| Topological Polar Surface Area | 46.5 Ų |
| Heavy Atom Count | 31 |
| Formal Charge | 0 |
| Complexity | 645 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
| 1 of 4 | |
|---|---|
| Drug Name | Adapalene |
| PubMed Health | Adapalene (On the skin) |
| Drug Classes | Antiacne |
| Drug Label | Adapalene 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 Ingredient | Adapalene |
| Dosage Form | Gel; Cream |
| Route | topical; Topical |
| Strength | 0.3%; 0.1% |
| Market Status | Tentative Approval; Prescription |
| Company | Glenmark Generics; Fougera Pharms; Actavis Mid Atlantic; Pliva Hrvatska Doo; Tolmar |
| 2 of 4 | |
|---|---|
| Drug Name | Differin |
| PubMed Health | Adapalene (On the skin) |
| Drug Classes | Antiacne |
| Drug Label | DIFFERIN 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 Ingredient | Adapalene |
| Dosage Form | Lotion; Gel; Cream |
| Route | Topical |
| Strength | 0.3%; 0.1% |
| Market Status | Prescription |
| Company | Galderma Labs |
| 3 of 4 | |
|---|---|
| Drug Name | Adapalene |
| PubMed Health | Adapalene (On the skin) |
| Drug Classes | Antiacne |
| Drug Label | Adapalene 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 Ingredient | Adapalene |
| Dosage Form | Gel; Cream |
| Route | topical; Topical |
| Strength | 0.3%; 0.1% |
| Market Status | Tentative Approval; Prescription |
| Company | Glenmark Generics; Fougera Pharms; Actavis Mid Atlantic; Pliva Hrvatska Doo; Tolmar |
| 4 of 4 | |
|---|---|
| Drug Name | Differin |
| PubMed Health | Adapalene (On the skin) |
| Drug Classes | Antiacne |
| Drug Label | DIFFERIN 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 Ingredient | Adapalene |
| Dosage Form | Lotion; Gel; Cream |
| Route | Topical |
| Strength | 0.3%; 0.1% |
| Market Status | Prescription |
| Company | Galderma Labs |
Adapalene is indicated for the topical treatment of acne vulgaris in patients aged 12 and over.
FDA Label
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.
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.)
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
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.
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.
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.
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.
API SUPPLIERS
Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
Certificate Number : R1-CEP 2016-309 - Rev 00
Issue Date : 2023-03-02
Type : Chemical
Substance Number : 2445
Status : Valid
Registration Number : 228MF10176
Registrant's Address : 5th Floor, Lakshminarayan Complex, 10/1, Palace Road, Bangalore-560052, India
Initial Date of Registration : 2016-08-29
Latest Date of Registration : --
Date of Issue : 2022-08-25
Valid Till : 2025-07-02
Written Confirmation Number : WC-0156
Address of the Firm : 61-B, Bommasandra Industrial Area, Bengaluru-560 099, India
Axplora- The partner of choice for complex APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8784
Submission : 1990-10-12
Status : Active
Type : II
Certificate Number : CEP 2021-229 - Rev 02
Issue Date : 2023-10-18
Type : Chemical
Substance Number : 2445
Status : Valid
Registrant Name : Galderma Korea Co., Ltd.
Registration Date : 2024-03-27
Registration Number : 20240327-209-J-1630
Manufacturer Name : FINORGA SAS
Manufacturer Address : Route de Givors Chasse Sur Rhone,38670, France
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Jai Radhe Sales is your partner for all your sourcing needs.
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-05-30
Pay. Date : 2013-05-21
DMF Number : 22709
Submission : 2009-04-08
Status : Active
Type : II
Registration Number : 228MF10126
Registrant's Address : 71, UDYOG KSHETRA, ULND-GOREGAON LINK ROAD, MULUND (W), MUMBAI 400080, INDIA
Initial Date of Registration : 2016-07-13
Latest Date of Registration : --
Date of Issue : 2023-01-06
Valid Till : 2025-07-29
Written Confirmation Number : WC-0099
Address of the Firm : Plot No. E-50, Unit-IV, MIDC, Tarapur - 401506, Taluka: Palghar, District: Thane-Zone 4.
NDC Package Code : 15308-0716
Start Marketing Date : 1997-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Inseong Trading Co., Ltd.
Registration Date : 2023-09-13
Registration Number : 20230110-209-J-1433(1)
Manufacturer Name : Aarti Pharmalabs limited
Manufacturer Address : Unit – IV, Plot No: E – 50, 50/1 & 59/1, MIDC, Tarapur, Taluka & District: Palghar, Pin-401 506 Maharashtra, India.
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-05-09
Pay. Date : 2013-04-25
DMF Number : 21480
Submission : 2008-03-26
Status : Active
Type : II
NDC Package Code : 53296-0068
Start Marketing Date : 2010-05-21
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (75kg/75kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-07-07
Pay. Date : 2014-03-11
DMF Number : 21208
Submission : 2008-01-02
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-02-08
Pay. Date : 2012-11-26
DMF Number : 18756
Submission : 2005-09-12
Status : Active
Type : II
Certificate Number : R1-CEP 2012-207 - Rev 01
Issue Date : 2022-12-06
Type : Chemical
Substance Number : 2445
Status : Valid
Registration Number : 226MF10072
Registrant's Address : 4th Floor, OIA House, 470, Cardinal Gracious Road, Andheri East Mumbai 400099, Maharashtra, India
Initial Date of Registration : 2014-03-11
Latest Date of Registration : --
Date of Issue : 2022-06-07
Valid Till : 2025-06-25
Written Confirmation Number : WC-0057n
Address of the Firm : Plot No. 3109, GIDC, Industrial Estate, Ankleshwar-393 002, Bharuch, Gujarat
NDC Package Code : 66039-801
Start Marketing Date : 2005-09-12
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39063
Submission : 2023-10-21
Status : Active
Type : II
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USDMF
Axplora- The partner of choice for complex APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8784
Submission : 1990-10-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-07
Pay. Date : 2014-03-11
DMF Number : 21208
Submission : 2008-01-02
Status : Active
Type : II
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-30
Pay. Date : 2013-05-21
DMF Number : 22709
Submission : 2009-04-08
Status : Active
Type : II
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-09
Pay. Date : 2013-04-25
DMF Number : 21480
Submission : 2008-03-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-08
Pay. Date : 2012-11-26
DMF Number : 18756
Submission : 2005-09-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18826
Submission : 2005-09-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-11-12
Pay. Date : 2014-02-14
DMF Number : 19621
Submission : 2006-07-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20064
Submission : 2006-12-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18831
Submission : 2005-09-22
Status : Inactive
Type : II
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CEP/COS
Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
Certificate Number : R1-CEP 2016-309 - Rev 00
Status : Valid
Issue Date : 2023-03-02
Type : Chemical
Substance Number : 2445
Certificate Number : CEP 2021-229 - Rev 02
Status : Valid
Issue Date : 2023-10-18
Type : Chemical
Substance Number : 2445
Certificate Number : R1-CEP 2012-207 - Rev 01
Status : Valid
Issue Date : 2022-12-06
Type : Chemical
Substance Number : 2445
Certificate Number : R0-CEP 2021-328 - Rev 00
Status : Valid
Issue Date : 2022-09-05
Type : Chemical
Substance Number : 2445
Certificate Number : R0-CEP 2022-259 - Rev 00
Status : Valid
Issue Date : 2023-07-28
Type : Chemical
Substance Number : 2445
Certificate Number : CEP 2022-158 - Rev 00
Status : Valid
Issue Date : 2024-06-19
Type : Chemical
Substance Number : 2445
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Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
Registration Number : 228MF10176
Registrant's Address : 5th Floor, Lakshminarayan Complex, 10/1, Palace Road, Bangalore-560052, India
Initial Date of Registration : 2016-08-29
Latest Date of Registration : 2021-03-09
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
Registration Number : 228MF10126
Registrant's Address : 71, UDYOG KSHETRA, ULND-GOREGAON LINK ROAD, MULUND (W), MUMBAI 400080, INDIA
Initial Date of Registration : 2016-07-13
Latest Date of Registration : 2016-07-13
Registration Number : 226MF10072
Registrant's Address : 4th Floor, OIA House, 470, Cardinal Gracious Road, Andheri East Mumbai 400099, Mahara...
Initial Date of Registration : 2014-03-11
Latest Date of Registration : 2017-05-16
Registration Number : 228MF10145
Registrant's Address : Strada Rivoltana km. 6/7 20053 Rodano (MI), Italy
Initial Date of Registration : 2016-08-03
Latest Date of Registration : 2019-12-20
Registration Number : 228MF10167
Registrant's Address : 1133 Oe, Imizu City, Toyama Prefecture
Initial Date of Registration : 2016-08-19
Latest Date of Registration : 2021-01-20
Registration Number : 228MF10149
Registrant's Address : 6-8, Fructo(´)s Gelabert 08970 Sant Joan Despi(´)(Barcelona)Spain
Initial Date of Registration : 2016-08-03
Latest Date of Registration : 2016-08-03
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Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
Date of Issue : 2022-08-25
Valid Till : 2025-07-02
Written Confirmation Number : WC-0156
Address of the Firm : 61-B, Bommasandra Industrial Area, Bengaluru-560 099, India
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
Date of Issue : 2023-01-06
Valid Till : 2025-07-29
Written Confirmation Number : WC-0099
Address of the Firm : Plot No. E-50, Unit-IV, MIDC, Tarapur - 401506, Taluka: Palghar, District: Thane...
Date of Issue : 2022-06-07
Valid Till : 2025-06-25
Written Confirmation Number : WC-0057n
Address of the Firm : Plot No. 3109, GIDC, Industrial Estate, Ankleshwar-393 002, Bharuch, Gujarat
Date of Issue : 2022-04-04
Valid Till : 2025-01-13
Written Confirmation Number : WC-0331
Address of the Firm : Plot No. 38, Rafaleshwar, GIDC, N. H. No 8/A, At & post Jambudia - 363 642 Tal: ...
Date of Issue : 2022-06-08
Valid Till : 2025-07-25
Written Confirmation Number : WC-0159
Address of the Firm : A-7/A-8, MIDC, Ahmednagar-414 111, Maharashtra State
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Registrant Name : Galderma Korea Co., Ltd.
Registration Date : 2024-03-27
Registration Number : 20240327-209-J-1630
Manufacturer Name : FINORGA SAS
Manufacturer Address : Route de Givors Chasse Sur Rhone,38670, France
Registrant Name : Galderma Korea Co., Ltd.
Registration Date : 2023-08-24
Registration Number : 20230824-209-J-1526
Manufacturer Name : FINORGA SAS
Manufacturer Address : route de Givors Chasse Sur Rhone,38670, France
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
Registrant Name : Inseong Trading Co., Ltd.
Registration Date : 2023-09-13
Registration Number : 20230110-209-J-1433(1)
Manufacturer Name : Aarti Pharmalabs limited
Manufacturer Address : Unit – IV, Plot No: E – 50, 50/1 & 59/1, MIDC, Tarapur, Taluka & District: Palgha...
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
Registrant Name : Iksoo Pharmaceutical Co., Ltd.
Registration Date : 2023-01-10
Registration Number : 20230110-209-J-1433
Manufacturer Name : Aarti Pharmalabs limited
Manufacturer Address : Unit – IV, Plot No: E – 50, 50/1 & 59/1, MIDC, Tarapur, Taluka & District: Palgha...
Registrant Name : Galderma Korea Co., Ltd.
Registration Date : 2024-03-27
Registration Number : 20240327-209-J-1631
Manufacturer Name : HAS Healthcare Advanced Synt...
Manufacturer Address : Via Industria 24, 6710 Biasca, Switzerland
Registrant Name : Galderma Korea Co., Ltd.
Registration Date : 2023-08-24
Registration Number : 20230824-209-J-1527
Manufacturer Name : HAS Healthcare Advanced Synt...
Manufacturer Address : Via Industria 24, 6710 Biasca, Switzerland
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DOSAGE - GEL;TOPICAL - 0.1%
USFDA APPLICATION NUMBER - 20380
DOSAGE - GEL;TOPICAL - 0.3%
USFDA APPLICATION NUMBER - 21753
DOSAGE - LOTION;TOPICAL - 0.1%
USFDA APPLICATION NUMBER - 22502
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Dosage Form : Tablet
Grade : Oral, Parenteral, Topical
Brand Name : MONTANE 80 PHA PREMIUM
Application : Emulsifying Agents
Pharmacopoeia Ref : USP-NF, EP, JP
Technical Specs : Non-Ionic Lipophilic surfactant; Emulsifier (w/o emulsions)
Ingredient(s) : sorbitan oleate
Dosage Form : Tablet
Grade : Oral, Topical
Brand Name : MONTANOX 80 PHA PREMIUM
Application : Emulsifying Agents
Pharmacopoeia Ref : USP-NF, EP, JP
Technical Specs : Non-Ionic Hydrophilic surfactant, Emulsifier (o/w emulsion), Solubilizer
Ingredient(s) : Polysorbate 80
Dosage Form : Capsule
Grade : Oral
Application : Coating Systems & Additives
Excipient Details : Ready mix Non-Functional film coating system.
Pharmacopoeia Ref : USP, EP, JP; Having US-DMF
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Methyl Cellulose
Dosage Form : Emulsion
Grade : Topical
Application : Rheology Modifiers
Excipient Details : Thickener, Emulsifier, Stabilizer, Texturizing agent, pH Independent & Non Thixotropic polymer for Topical Range (Skin,Vaginal & Anal mucosa)
Pharmacopoeia Ref : In house having US DMF Type IV...
Technical Specs : Ready to use liquid polymer for topical applications (Gel / Cream / Lotion/ Foam based formulation, ...
Ingredient(s) : Hydroxyethyl Acrylate
Dosage Form : Capsule
Grade : Oral
Application : Solubilizers
Excipient Details : Polysorbate 80 in dry powder form, a solubilizing agent acts as a surfactant and increases the solubility of various oral dosage forms.
Pharmacopoeia Ref : USP-NF, EP, JP & having US DMF
Technical Specs : Solubilizer in powder form, used in directly compressible dosage forms, Wet granulation, added durin...
Ingredient(s) : Magnesium aluminium silicate Excipient
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