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Chemistry

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Also known as: 55079-83-9, Etretin, Soriatane, Neotigason, Acitretine, All-trans-acitretin

Molecular Formula

C₂₁H₂₆O₃

Molecular Weight

326.4 g/mol

InChI Key

IHUNBGSDBOWDMA-AQFIFDHZSA-N

FDA UNII

LCH760E9T7

An oral retinoid effective in the treatment of psoriasis. It is the major metabolite of ETRETINATE with the advantage of a much shorter half-life when compared with etretinate.

Acitretin is a Retinoid.

1 2D Structure

Acitretin

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(2E,4E,6E,8E)-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethylnona-2,4,6,8-tetraenoic acid

2.1.2 InChI

InChI=1S/C21H26O3/c1-14(8-7-9-15(2)12-21(22)23)10-11-19-16(3)13-20(24-6)18(5)17(19)4/h7-13H,1-6H3,(H,22,23)/b9-7+,11-10+,14-8+,15-12+

2.1.3 InChI Key

IHUNBGSDBOWDMA-AQFIFDHZSA-N

2.1.4 Canonical SMILES

CC1=CC(=C(C(=C1C=CC(=CC=CC(=CC(=O)O)C)C)C)C)OC

2.1.5 Isomeric SMILES

CC1=CC(=C(C(=C1/C=C/C(=C/C=C/C(=C/C(=O)O)/C)/C)C)C)OC

2.2 Other Identifiers

2.2.1 UNII

LCH760E9T7

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 13-cis-acitretin

2. Acitretin, (z,e,e,e)-isomer

3. Etretin

4. Isoacitretin

5. Isoetretin

6. Neotigason

7. Ro 10-1670

8. Ro 101670

9. Ro 13-7652

10. Ro 137652

11. Ro-10-1670

12. Ro-13-7652

13. Ro101670

14. Ro137652

15. Soriatane

2.3.2 Depositor-Supplied Synonyms

1. 55079-83-9

2. Etretin

3. Soriatane

4. Neotigason

5. Acitretine

6. All-trans-acitretin

7. Retinoid Etretin

8. Ro 10-1670

9. (2e,4e,6e,8e)-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethylnona-2,4,6,8-tetraenoic Acid

10. Acitretina

11. Acitretinum

12. Tmmp

13. Ro 10-1670/000

14. 9-cis Acitretin

15. (all-e)-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic Acid

16. 54757-46-9

17. All-trans-3,7-dimethyl-9-(4-methoxy-2,3,6-trimethylphenyl)-2,4,6,8-nonatetraenoic Acid

18. Chebi:50173

19. 2,4,6,8-nonatetraenoic Acid, 9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-, (all-e)-

20. Ro-101670000

21. Lch760e9t7

22. Ro-10-1670/000

23. Ncgc00163127-02

24. Acitretine [french]

25. Acitretinum [latin]

26. Acitretina [spanish]

27. Acitretin 100 Microg/ml In Acetonitrile:acetone

28. 2,4,6,8-nonatetraenoic Acid, 3,7-dimethyl-9-(4-methoxy-2,3,6-trimethylphenyl)-, (all-e)-

29. Acetretin

30. 9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic Acid

31. Soriatane Ck

32. Soriatane (tn)

33. Ccris 5534

34. Ro-10-1670

35. Hsdb 7187

36. 419534-31-9

37. Einecs 259-474-4

38. Chebi:50172

39. Unii-lch760e9t7

40. U0279

41. All-trans-etretin

42. Acitretin [usan:usp:inn:ban]

43. Acitretin,(s)

44. Acitretin- Bio-x

45. Acitretin (usp/inn)

46. Acitretin [inn]

47. Acitretin [mi]

48. Acitretin [hsdb]

49. Acitretin [usan]

50. Spectrum5_002065

51. Acitretin [vandf]

52. Dsstox_cid_2553

53. Acitretin [mart.]

54. Acitretin [usp-rs]

55. Acitretin [who-dd]

56. Schembl3759

57. Chembl1131

58. Dsstox_rid_76624

59. Dsstox_gsid_22553

60. (2e,4e,6e,8e)-9-(4-methoxy-2,3,6-trimethyl-phenyl)-3,7-dimethyl-nona-2,4,6,8-tetraenoic Acid

61. Mls001076667

62. Bidd:gt0617

63. Gtpl7598

64. Acitretin [orange Book]

65. Acitretin [ep Monograph]

66. Acitretin [usp Impurity]

67. Dtxsid6022553

68. Acitretin [usp Monograph]

69. Bcpp000437

70. Hms2234l17

71. Hms3259j12

72. Hms3714e17

73. Acitretin, >=98.0% (hplc)

74. Hy-b0107

75. Zinc3798734

76. Tox21_112012

77. Bdbm50088429

78. Mfcd00866632

79. S1368

80. Stl565770

81. Akos015889991

82. Ac-4702

83. Bcp9000229

84. Ccg-220668

85. Cs-1855

86. Db00459

87. Ks-5246

88. 2,4,6,8-nonatetraenoic Acid, 9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-

89. Ncgc00163127-01

90. Ncgc00163127-03

91. (2e,4e,6e,8e)-3,7-dimethyl-9-[2,3,6-trimethyl-4-(methyloxy)phenyl]nona-2,4,6,8-tetraenoic Acid

92. (2e,4e,6e,8e)-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic Acid

93. As-12644

94. Ba164136

95. Smr000499573

96. Cas-55079-83-9

97. Cs-0368934

98. Sw199134-2

99. C75579

100. D02754

101. Ab00698376-08

102. Ab00698376_09

103. 079a839

104. A830475

105. Q341500

106. Sr-01000763200

107. Sr-01000763200-3

108. Brd-k90699611-001-01-4

109. Acitretin, British Pharmacopoeia (bp) Reference Standard

110. Acitretin, European Pharmacopoeia (ep) Reference Standard

111. Acitretin, United States Pharmacopeia (usp) Reference Standard

112. Acitretin, Pharmaceutical Secondary Standard; Certified Reference Material

113. 2,4,6,8-nonatetraenoic Acid, 9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-, (2e,4e,6e,8e)-

2.4 Create Date

2005-03-27

3 Chemical and Physical Properties

Molecular Formula	C₂₁H₂₆O₃
Molecular Weight	326.4 g/mol
XLogP3	6.1
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	3
Rotatable Bond Count	6
Exact Mass	326.18819469 g/mol
Monoisotopic Mass	326.18819469 g/mol
Topological Polar Surface Area	46.5 Å²
Heavy Atom Count	24
Formal Charge	0
Complexity	539
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	4
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Information

1 of 4
Drug Name	Acitretin
PubMed Health	Acitretin (By mouth)
Drug Classes	Antipsoriatic
Drug Label	Acitretin Capsules (acitretin), a retinoid, are available in 10 mg and 25 mg gelatin capsules for oral administration. Chemically, acitretin is all-trans-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic acid. It is a metabolite...
Active Ingredient	Acitretin
Dosage Form	Capsule
Route	Oral
Strength	22.5mg; 25mg; 10mg; 17.5mg
Market Status	Prescription
Company	Teva Pharms Usa; Barr Labs

2 of 4
Drug Name	Soriatane
PubMed Health	Acitretin (By mouth)
Drug Classes	Antipsoriatic
Drug Label	SORIATANE (acitretin), a retinoid, is available in 10 mg, 17.5 mg, and 25 mg gelatin capsules for oral administration. Chemically, acitretin is all-trans-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic acid. It is a metabolite...
Active Ingredient	Acitretin
Dosage Form	Capsule
Route	Oral
Strength	22.5mg; 25mg; 10mg; 17.5mg
Market Status	Prescription
Company	Stiefel Labs

3 of 4
Drug Name	Acitretin
PubMed Health	Acitretin (By mouth)
Drug Classes	Antipsoriatic
Drug Label	Acitretin Capsules (acitretin), a retinoid, are available in 10 mg and 25 mg gelatin capsules for oral administration. Chemically, acitretin is all-trans-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic acid. It is a metabolite...
Active Ingredient	Acitretin
Dosage Form	Capsule
Route	Oral
Strength	22.5mg; 25mg; 10mg; 17.5mg
Market Status	Prescription
Company	Teva Pharms Usa; Barr Labs

4 of 4
Drug Name	Soriatane
PubMed Health	Acitretin (By mouth)
Drug Classes	Antipsoriatic
Drug Label	SORIATANE (acitretin), a retinoid, is available in 10 mg, 17.5 mg, and 25 mg gelatin capsules for oral administration. Chemically, acitretin is all-trans-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic acid. It is a metabolite...
Active Ingredient	Acitretin
Dosage Form	Capsule
Route	Oral
Strength	22.5mg; 25mg; 10mg; 17.5mg
Market Status	Prescription
Company	Stiefel Labs

4.2 Therapeutic Uses

Keratolytic Agents

National Library of Medicine's Medical Subject Headings. Acitretin. Online file (MeSH, 2018). Available from, as of August 29, 2018: https://meshb.nlm.nih.gov/search

/CLINICAL TRIALS/ ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. The Web site is maintained by the National Library of Medicine (NLM) and the National Institutes of Health (NIH). Each ClinicalTrials.gov record presents summary information about a study protocol and includes the following: Disease or condition; Intervention (for example, the medical product, behavior, or procedure being studied); Title, description, and design of the study; Requirements for participation (eligibility criteria); Locations where the study is being conducted; Contact information for the study locations; and Links to relevant information on other health Web sites, such as NLM's MedlinePlus for patient health information and PubMed for citations and abstracts for scholarly articles in the field of medicine. Acitretin is included in the database.

NIH/NLM; ClinicalTrials.Gov. Available from, as of August 29, 2018: https://clinicaltrials.gov/

Acitretin Capsules, USP are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, Acitretin Capsules, USP should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, Acitretin Capsules, USP should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments /Included in US product labeling/

NIH; DailyMed. Current Medication Information for Acitretin Capsule (Updated: January 9, 2018). Available from, as of November 20, 2018: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6af396c2-af3e-436d-ba9a-583637495910

Acitretin has been used in a limited number of patients for the management of discoid lupus erythematosus; efficacy was similar to that of hydroxychloroquine, but adverse effects were more severe and frequent with acitretin. Further study is needed to establish the role of acitretin in treating this condition. /NOT included in US product labeling/

American Society of Health-System Pharmacists; Drug Information 2018. Bethesda, MD. 2018, p. 3548

For more Therapeutic Uses (Complete) data for Acitretin (9 total), please visit the HSDB record page.

4.3 Drug Warning

/BOXED WARNING/ CONTRAINDICATIONS AND WARNINGS: Pregnancy. Acitretin must not be used by females who are pregnant, or who intend to become pregnant during therapy or at any time for at least 3 years following discontinuation of therapy. Acitretin also must not be used by females who may not use reliable contraception while undergoing treatment and for at least 3 years following discontinuation of treatment. Acitretin is a metabolite of etretinate (TEGISON), and major human fetal abnormalities have been reported with the administration of acitretin and etretinate. Potentially, any fetus exposed can be affected. Clinical evidence has shown that concurrent ingestion of acitretin and ethanol has been associated with the formation of etretinate, which has a significantly longer elimination half-life than acitretin. Because the longer elimination half-life of etretinate would increase the duration of teratogenic potential for female patients, ethanol must not be ingested by female patients of childbearing potential either during treatment with acitretin or for 2 months after cessation of therapy. This allows for elimination of acitretin, thus removing the substrate for transesterification to etretinate. The mechanism of the metabolic process for conversion of acitretin to etretinate has not been fully defined. It is not known whether substances other than ethanol are associated with transesterification. Acitretin has been shown to be embryotoxic and/or teratogenic in rabbits, mice, and rats at oral doses of 0.6, 3, and 15 mg per kg, respectively. These doses are approximately 0.2, 0.3, and 3 times the maximum recommended therapeutic dose, respectively, based on a mg-per-m 2 comparison. Major human fetal abnormalities associated with acitretin and/or etretinate administration have been reported including meningomyelocele; meningoencephalocele; multiple synostoses; facial dysmorphia; syndactyly; absence of terminal phalanges; malformations of hip, ankle, and forearm; low-set ears; high palate; decreased cranial volume; cardiovascular malformation; and alterations of the skull and cervical vertebrae. Acitretin should be prescribed only by those who have special competence in the diagnosis and treatment of severe psoriasis, are experienced in the use of systemic retinoids, and understand the risk of teratogenicity. Because of the teratogenicity of acitretin, a program called P.P.E.T., Pregnancy Prevention is Essential with Treatment, has been developed to educate women of childbearing potential and their healthcare providers about the serious risks associated with acitretin and to help prevent pregnancies from occurring with the use of this drug and for 3 years after its discontinuation.

/BOXED WARNING/ Hepatotoxicity: Of the 525 subjects treated in US clinical trials, 2 had clinical jaundice with elevated serum bilirubin and transaminases considered related to treatment with acitretin. Liver function test results in these subjects returned to normal after acitretin was discontinued. Two of the 1,289 subjects treated in European clinical trials developed biopsy-confirmed toxic hepatitis. A second biopsy in one of these subjects revealed nodule formation suggestive of cirrhosis. One subject in a Canadian clinical trial of 63 subjects developed a 3-fold increase of transaminases. A liver biopsy of this subject showed mild lobular disarray, multifocal hepatocyte loss, and mild triaditis of the portal tracts compatible with acute reversible hepatic injury. The subject's transaminase levels returned to normal 2 months after acitretin was discontinued. The potential of therapy with acitretin to induce hepatotoxicity was prospectively evaluated using liver biopsies in an open-label trial of 128 subjects. Pretreatment and posttreatment biopsies were available for 87 subjects. A comparison of liver biopsy findings before and after therapy revealed 49 (58%) subjects showed no change, 21 (25%) improved, and 14 (17%) subjects had a worsening of their liver biopsy status. For 6 subjects, the classification changed from class 0 (no pathology) to class I (normal fatty infiltration; nuclear variability and portal inflammation; both mild); for 7 subjects, the change was from class I to class II (fatty infiltration, nuclear variability, portal inflammation, and focal necrosis; all moderate to severe); and for 1 subject, the change was from class II to class IIIb (fibrosis, moderate to severe). No correlation could be found between liver function test result abnormalities and the change in liver biopsy status, and no cumulative dose relationship was found. Elevations of AST (SGOT), ALT (SGPT), GGT (GGTP), or LDH have occurred in approximately 1 in 3 subjects treated with acitretin. Of the 525 subjects treated in clinical trials in the US, treatment was discontinued in 20 (3.8%) due to elevated liver function test results. If hepatotoxicity is suspected during treatment with acitretin, the drug should be discontinued and the etiology further investigated. Ten of 652 subjects treated in US clinical trials of etretinate, of which acitretin is the active metabolite, had clinical or histologic hepatitis considered to be possibly or probably related to etretinate treatment. There have been reports of hepatitis-related deaths worldwide; a few of these subjects had received etretinate for a month or less before presenting with hepatic symptoms or signs.

Acitretin is a known human teratogen, and there is a very high risk of severe birth defects if a patient becomes pregnant while receiving acitretin or upon drug discontinuance (birth defects have been reported 2 years or longer after the last dose of acitretin). Teratogenicity generally is characterized by malformations involving craniofacial, cardiovascular, skeletal, and CNS structures. Use of acitretin is contraindicated during pregnancy. The drug must not be used in female patients who are or may become pregnant during acitretin therapy or within at least 3 years following drug discontinuance or in females who may not use reliable contraception during and for at least 3 years following cessation of therapy. If pregnancy occurs during therapy or at any time for at least 3 years following drug discontinuance, the clinician and patient should discuss the possible effects on the pregnancy.

American Society of Health-System Pharmacists; Drug Information 2018. Bethesda, MD. 2018, p. 3549

Acitretin is distributed into milk; women receiving the drug should not breast-feed.

American Society of Health-System Pharmacists; Drug Information 2018. Bethesda, MD. 2018, p. 3549

For more Drug Warnings (Complete) data for Acitretin (20 total), please visit the HSDB record page.

4.4 Drug Indication

For the treatment of severe psoriasis in adults.

FDA Label

5 Pharmacology and Biochemistry

5.1 Pharmacology

Acitretin is a retinoid. Retinoids have a structure similar to vitamin A and are involved in the normal growth of skin cells. Acitretin works by inhibiting the excessive cell growth and keratinisation (process by which skin cells become thickened due to the deposition of a protein within them) seen in psoriasis. It therefore reduces the thickening of the skin, plaque formation and scaling.

5.2 MeSH Pharmacological Classification

Keratolytic Agents

Agents that soften, separate, and cause desquamation of the cornified epithelium or horny layer of skin. They are used to expose mycelia of infecting fungi or to treat corns, warts, and certain other skin diseases. (See all compounds classified as Keratolytic Agents.)

5.3 FDA Pharmacological Classification

5.3.1 Active Moiety

ACITRETIN

5.3.2 FDA UNII

LCH760E9T7

5.3.3 Pharmacological Classes

Retinoids [CS]; Retinoid [EPC]

5.4 ATC Code

D - Dermatologicals

D05 - Antipsoriatics

D05B - Antipsoriatics for systemic use

D05BB - Retinoids for treatment of psoriasis

D05BB02 - Acitretin

5.5 Absorption, Distribution and Excretion

Absorption

Oral absorption of acitretin is optimal when given with food, and is linear and proportional with increasing doses from 25 to 100 mg. Approximately 72% (range 47% to 109%) of the administered dose was absorbed after a single 50 mg dose of acitretin was given to 12 healthy subjects.

Route of Elimination

Both parent compound and isomer are further metabolized into chain-shortened breakdown products and conjugates, which are excreted. The chain-shortened metabolites and conjugates of acitretin and cis-acitretin are ultimately excreted in the feces (34% to 54%) and urine (16% to 53%).

/MILK/ Acitretin is distributed into milk ... .

American Society of Health-System Pharmacists; Drug Information 2018. Bethesda, MD. 2018, p. 3549

/MILK/ Retinoid transfer into breast milk was studied in a psoriatric woman receiving oral acitretin at a dosage of 40 mg once daily. Concentrations of the parent compound and its main metabolite, 13-cis acitretin, were measured in serum and mature milk during the initial nine days of therapy, using reverse-phase high performance liquid chromatography. At steady-state, trace amounts of the drug and metabolite (30-40 ng/mL) appeared in breast milk corresponding to a milk/serum concentration ratio of about 0.18. Acitretin was almost exclusively distributed in the fatty layers of the milk. Although the estimated amount of the drug consumed by a suckling infant would correspond to only 1.5% of the maternal dose, the toxic potential of acitretin justifies its avoidance in breast-feeding women.

PMID:1981420 Rollman O, Pihl-Lundin I; Acta Derm Venereol 70 (6): 487-90 (1990)

Oral absorption of acitretin is optimal when given with food. For this reason, acitretin was given with food in all of the following trials. After administration of a single 50-mg oral dose of acitretin to 18 healthy subjects, maximum plasma concentrations ranged from 196 to 728 ng per mL (mean: 416 ng per mL) and were achieved in 2 to 5 hours (mean: 2.7 hours). The oral absorption of acitretin is linear and proportional with increasing doses from 25 to 100 mg. Approximately 72% (range: 47% to 109%) of the administered dose was absorbed after a single 50-mg dose of acitretin was given to 12 healthy subjects.

Acitretin is more than 99.9% bound to plasma proteins, primarily albumin.

For more Absorption, Distribution and Excretion (Complete) data for Acitretin (7 total), please visit the HSDB record page.

5.6 Metabolism/Metabolites

Following oral absorption, acitretin undergoes extensive metabolism and interconversion by simple isomerization to its 13-cis form (cis-acitretin). Both parent compound and isomer are further metabolized into chain-shortened breakdown products and conjugates, which are excreted.

Following oral absorption, acitretin undergoes extensive metabolism and interconversion by simple isomerization to its 13-cis form (cis-acitretin). The formation of cis-acitretin relative to parent compound is not altered by dose or fed/fast conditions of oral administration of acitretin. Both parent compound and isomer are further metabolized into chain-shortened breakdown products and conjugates, which are excreted. Following multiple-dose administration of acitretin, steady-state concentrations of acitretin and cis-acitretin in plasma are achieved within approximately 3 weeks.

... In the presence of ethanol the ethyl esterification of acitretin to etretinate proceeds via formation of acitretinoyl-CoA.

PMID:10874125 Knights KM et al; Biochem Pharmacol 60 (4): 507-16 (2000)

5.7 Biological Half-Life

49 hours (range 33 to 96 hours)

... 10 patients with severe psoriasis were treated with 30 mg acitretin daily for 3 months. ... After discontinuation of therapy, the rate of elimination of both acitretin (half life range 1.0 to 25.4 days) and 13-cis-acitretin (half life range 1.5 to 25.7 days) was found to be related to the observed mean steady-state level of etretinate as evidenced by a longer terminal half life of patients with high levels of etretinate in plasma. ...

PMID:8491984 Larsen FG et al; J Invest Dermatol 100 (5): 623-7 (1993)

The terminal elimination half-life of acitretin following multiple-dose administration is 49 hours (range: 33 to 96 hours), and that of cis-acitretin under the same conditions is 63 hours (range: 28 to 157 hours).

5.8 Mechanism of Action

The mechanism of action of acitretin is unknown, however it is believed to work by targeting specific receptors (retinoid receptors such as RXR and RAR) in the skin which help normalize the growth cycle of skin cells.

API SUPPLIERS

01

Biophore India Pharmaceuticals Pvt...

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI India 2024

Booth #1.A01

Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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India

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Digital Content

USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

02

USV Private Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI India 2024

Attending

USV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.

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India

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Digital Content

USDMF

CEP/COS JDMF EU-WC

NDC

KDMF VMF Others AUDIT

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03

Olon S.p.A

Italy

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Compamed

Not Confirmed

04

Olon S.p.A

Italy

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Compamed

Not Confirmed

05

Solara Active Pharma Sciences

India

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Compamed

Not Confirmed

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USDMF

01

Usv Private Ltd

India

CPhI India 2024

Attending

USV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.

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India

Virtual Booth

Digital Content

Acitretin Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 23310

Submission : 2009-12-10

Status : Active

Type : II

Portfolio PDF

02

Basf Se

Country

Compamed

Not Confirmed

Not Confirmed

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CEP/COS

01

BASF SE Ludwigshafen DE

Germany

Italy

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API Reference Price

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NO. - CT-17\/WZ\/1106\/2019\/1044)","address":"Sadoday Gyan Ground Floor Opp NADT Nelson Square Nagpur Co","city":"NAGPUR","supplier":"CHONGQING HUAPONT PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"NA","customer":"ZIM LABORATORIES","customerCountry":"INDIA","quantity":"0.15","actualQuantity":"0.15","unit":"KGS","unitRateFc":"6153.3","totalValueFC":"1301.7","currency":"USD","unitRateINR":"690021.1","date":"21-Jul-2022","totalValueINR":"103503.16","totalValueInUsd":"1301.7","indian_port":"BOMBAY AIR","hs_no":"29189990","bill_no":"9655952","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Micronized","supplierPort":"NA","supplierAddress":"","customerAddress":"Sadoday Gyan Ground Floor Opp NADT Nelson Square Nagpur Co"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1660847400,"product":"ACITRETIN ETHYL ESTER(INTERMEDIATE CHEMICALS)","address":"PLOT NO A1 2402 2 GIDC ESTATE,ANK LESHWAR","city":"BHARUCH,GUJARAT","supplier":"SUNERGY PHARMACHEM GROUP CO.","supplierCountry":"CHINA","foreign_port":"NA","customer":"JAY JALARAM ENTERPRISE","customerCountry":"INDIA","quantity":"30.00","actualQuantity":"30","unit":"KGS","unitRateFc":"2100","totalValueFC":"63738.6","currency":"USD","unitRateINR":"169050","date":"19-Aug-2022","totalValueINR":"5071500","totalValueInUsd":"63738.6","indian_port":"DELHI AIR","hs_no":"29339990","bill_no":"2072613","productDescription":"Intermediate","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PLOT NO A1 2402 2 GIDC ESTATE,ANK LESHWAR"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1690569000,"product":"2611640 ACITRETIN MICRO USP\/EP CURRENT EDITION","address":"12TH FLOOR, COMMERZ II,,INTERNATIO NAL BUSNESS PARK,OBEROI","city":"GARDEN CITY OFF WESTERN EXPR HIGHWA","supplier":"OLON S.P.A","supplierCountry":"ITALY","foreign_port":"NA","customer":"TEVA PHARMACEUTICAL INDUSTRIES","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"23000","totalValueFC":"232128.1","currency":"USD","unitRateINR":"1907849.9","date":"29-Jul-2023","totalValueINR":"19078499.71","totalValueInUsd":"232128.1","indian_port":"BOMBAY AIR","hs_no":"29189990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"12TH FLOOR, COMMERZ II,,INTERNATIO NAL BUSNESS PARK,OBEROI"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1714242600,"product":"ACITRETIN USP","address":"ALEMBIC ROAD","city":"GUJARAT","supplier":"OLONA S.P.A.","supplierCountry":"ITALY","foreign_port":"MILAN","customer":"ALEMBIC PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"2.69","actualQuantity":"2.69","unit":"KGS","unitRateFc":"7000","totalValueFC":"20463.1","currency":"EUR","unitRateINR":"635250","date":"28-Apr-2024","totalValueINR":"1708822.5","totalValueInUsd":"20463.1","indian_port":"Bombay Air","hs_no":"29182390","bill_no":"3244252","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN","supplierAddress":"DIREZIONE E UFFICISTR.RIVOLTANA KM6\/720053 RODANO (MI)SDNF ITALY","customerAddress":"ALEMBIC ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1714242600,"product":"ACITRETIN USP","address":"ALEMBIC ROAD","city":"GUJARAT","supplier":"OLONA S.P.A.","supplierCountry":"ITALY","foreign_port":"MILAN","customer":"ALEMBIC PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"6.60","actualQuantity":"6.6","unit":"KGS","unitRateFc":"7000","totalValueFC":"50207","currency":"EUR","unitRateINR":"635250","date":"28-Apr-2024","totalValueINR":"4192650","totalValueInUsd":"50207","indian_port":"Bombay Air","hs_no":"29182390","bill_no":"3244252","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN","supplierAddress":"DIREZIONE E UFFICISTR.RIVOLTANA KM6\/720053 RODANO (MI)SDNF ITALY","customerAddress":"ALEMBIC ROAD"}]

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API Imports and Exports

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

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INTERMEDIATES SUPPLIERS

euroPLX 86 Munich

Not Confirmed

10

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euroPLX 86 Munich

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DOSAGE - CAPSULE;ORAL - 10MG **Federal Regist...DOSAGE - CAPSULE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 19821

DOSAGE - CAPSULE;ORAL - 17.5MG **Federal Regi...DOSAGE - CAPSULE;ORAL - 17.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 19821

DOSAGE - CAPSULE;ORAL - 22.5MG **Federal Regi...DOSAGE - CAPSULE;ORAL - 22.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 19821

DOSAGE - CAPSULE;ORAL - 25MG **Federal Regist...DOSAGE - CAPSULE;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 19821

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3 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

84 FDF Dossiers

23 FDA Orange Book

38 Europe

6 Canada

4 Australia

4 South Africa

9 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE;ORAL - 17.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE;ORAL - 22.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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1 Rochem International Inc

2 SPI Pharma

7 DKSH

3 Faran Shimi Pharmaceutical

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1 Actylis

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18 BASF

2 DFE Pharma

1 Finar

6 Gangwal Chemicals

1 Ideal Cures Pvt Ltd

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1 Novo Excipients

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1 Prachin Chemical

1 Qualicaps

14 Roquette

1 Seppic

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8 Sigachi Industries

2 Ulanqab Kema New Material

1 Valens Pharmachem

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EXCIPIENTS BY APPLICATIONS

33 Fillers, Diluents & Binders

22 Thickeners and Stabilizers

22 Direct Compression

16 Granulation

15 Solubilizers

11 Coating Systems & Additives

10 Co-Processed Excipients

8 Controlled & Modified Release

8 Film Formers & Plasticizers

8 Taste Masking

8 Empty Capsules

7 Disintegrants & Superdisintegrants

7 Topical

5 Lubricants & Glidants

5 Parenteral

4 Chewable & Orodispersible Aids

3 Coloring Agents

2 Emulsifying Agents

1 Rheology Modifiers

CAPSULE;ORAL - 10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE;ORAL - 17.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE;ORAL - 22.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE;ORAL - 25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons