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ACTIVE PHARMA INGREDIENTS

10 API Suppliers, 6 USDMF, 5 CEP/COS, 1 KDMF, 5 NDC API, 6 Listed Suppliers, $ API Reference Price

10 API Suppliers
6 USDMF
5 CEP/COS
1 KDMF
5 NDC API
6 Listed Suppliers
$ API Reference Price

FINISHED DOSAGE FORMULATIONS

93 FDF Dossiers, 32 FDA Orange Book, 54 Europe, 3 Canada, 4 Listed Dossiers

93 FDF Dossiers
32 FDA Orange Book
54 Europe
3 Canada
4 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CREAM;TOPICAL - 0.77%, SUSPENSION;TOPICAL - 0.77%, GEL;TOPICAL - 0.77% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;TOPICAL - 8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SHAMPOO;TOPICAL - 1%

drugProductComposition
CREAM;TOPICAL - 0.77%
SUSPENSION;TOPICAL - 0.77%
GEL;TOPICAL - 0.77% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SOLUTION;TOPICAL - 8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SHAMPOO;TOPICAL - 1%

RELATED EXCIPIENT COMPANIES

1 Seqens, 1 DKSH, 1 Faran Shimi Pharmaceutical, 5 Nanjing Well Pharmaceutical, 2 Actylis, 8 BASF, 2 Corel Pharma Chem, 1 Finar, 1 Kerry, 2 Lubrizol Life Science Health, 1 Pluviaendo, 1 Valens Pharmachem

relatedExcipients
1 Seqens
1 DKSH
1 Faran Shimi Pharmaceutical
5 Nanjing Well Pharmaceutical
2 Actylis
8 BASF
2 Corel Pharma Chem
1 Finar
1 Kerry
2 Lubrizol Life Science Health
1 Pluviaendo
1 Valens Pharmachem

EXCIPIENTS BY APPLICATIONS

13 Topical, 6 Parenteral, 5 Solubilizers, 3 Granulation, 3 Coating Systems & Additives, 3 Thickeners and Stabilizers, 3 Film Formers & Plasticizers, 2 Lubricants & Glidants, 2 Taste Masking, 2 Emulsifying Agents, 2 Controlled & Modified Release, 1 Direct Compression, 1 Surfactant & Foaming Agents

excipientsByApplications
13 Topical
6 Parenteral
5 Solubilizers
3 Granulation
3 Coating Systems & Additives
3 Thickeners and Stabilizers
3 Film Formers & Plasticizers
2 Lubricants & Glidants
2 Taste Masking
2 Emulsifying Agents
2 Controlled & Modified Release
1 Direct Compression
1 Surfactant & Foaming Agents

DIGITAL CONTENT

6 NEWS #PharmaBuzz

media
6 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 66 Finished Drug Prices

globalSalesInformation
3 US Medicaid Prescriptions
66 Finished Drug Prices

MARKET PLACE

8 APIs

marketPlace
8 APIs

PATENTS & EXCLUSIVITIES

1 Health Canada Patents

patents
1 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM , 3 USP , 6 Others

otherSolutions
4 EDQM
3 USP
6 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 382

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

0 DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

39,008,248

Annual Reports (USD Million)

Finished Drug Prices

26 RELATED EXCIPIENT COMPANIES

46EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 29342-05-0, Loprox, Penlac, Hoe 296b, Cyclopirox, Ciclopiroxum

Molecular Formula

C₁₂H₁₇NO₂

Molecular Weight

207.27 g/mol

InChI Key

SCKYRAXSEDYPSA-UHFFFAOYSA-N

FDA UNII

19W019ZDRJ

A cyclohexane and pyridinone derivative that is used for the treatment of fungal infections of the skin and nails, and for treatment of VAGINAL YEAST INFECTIONS.

The mechanism of action of ciclopirox is as a Protein Synthesis Inhibitor. The physiologic effect of ciclopirox is by means of Decreased DNA Replication, and Decreased Protein Synthesis, and Decreased RNA Replication.

1 2D Structure

Ciclopirox

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

6-cyclohexyl-1-hydroxy-4-methylpyridin-2-one

2.1.2 InChI

InChI=1S/C12H17NO2/c1-9-7-11(13(15)12(14)8-9)10-5-3-2-4-6-10/h7-8,10,15H,2-6H2,1H3

2.1.3 InChI Key

SCKYRAXSEDYPSA-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CC1=CC(=O)N(C(=C1)C2CCCCC2)O

2.2 Other Identifiers

2.2.1 UNII

19W019ZDRJ

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 6-cyclohexyl-1-hydroxy-4-methyl-2(1h)-pyridone Ethanolamine Salt

2. Batrafen

3. Ciclopirox Olamine

4. Ciclopiroxolamine

5. Cyclopirox

6. Cyclopyroxolamine

7. Dafnegin Csc

8. Dafnegin-csc

9. Hoe 296

10. Hoe-296

11. Hoe296

12. Loprox

13. Penlac

2.3.2 Depositor-Supplied Synonyms

1. 29342-05-0

2. Loprox

3. Penlac

4. Hoe 296b

5. Cyclopirox

6. Ciclopiroxum

7. Hoe-296b

8. Ciclopiroxum [inn-latin]

9. 2(1h)-pyridinone, 6-cyclohexyl-1-hydroxy-4-methyl-

10. 6-cyclohexyl-1-hydroxy-4-methylpyridin-2(1h)-one

11. 6-cyclohexyl-1-hydroxy-4-methylpyridin-2-one

12. 6-cyclohexyl-1-hydroxy-4-methyl-2(1h)-pyridinone

13. Hoe296b

14. Ciclopirox (penlac)

15. Loprox (tn)

16. 19w019zdrj

17. Terit

18. Chebi:453011

19. 29342-05-0 (free)

20. Stieprox

21. Ciclopirox Gel

22. Loprox Cream

23. Loprox Gel

24. Ciclopirox Olamin

25. Ciclopirox-olamin

26. 6-cyclohexyl-4-methyl-1-oxidanyl-pyridin-2-one

27. 6-cyclohexyl-1-hydroxy-4-methyl-2(1h)-pyridone

28. 6-cyclohexyl-1-hydroxy-4-methyl-1h-pyridin-2-one

29. Mls002153867

30. Penlac (tn)

31. Ciclopirox (usp/inn)

32. Cnl8

33. Smr001233223

34. Einecs 249-577-2

35. Unii-19w019zdrj

36. Ciclodan

37. Ciclopirox [usan:usp:inn:ban]

38. 2(1h)-pyridone, 6-cyclohexyl-1-hydroxy-4-methyl-

39. Ciclopirox [mi]

40. Ciclopirox [inn]

41. Prestwick0_000541

42. Prestwick1_000541

43. Prestwick2_000541

44. Prestwick3_000541

45. Spectrum2_000146

46. Spectrum3_000351

47. Spectrum4_000288

48. Spectrum5_000747

49. Ciclopirox [usan]

50. Ciclopirox [vandf]

51. 6-cyclohexyl-1-hydroxy-4-methyl-pyridin-2-one

52. Ciclopirox [mart.]

53. Chembl1413

54. Ciclopirox [usp-rs]

55. Ciclopirox [who-dd]

56. Schembl34424

57. Bspbio_000581

58. Bspbio_002041

59. Kbiogr_000816

60. 6-cyclohexyl-1-hydroxy-4-methyl-2-(1h)-pyridone

61. Cid_38911

62. Bidd:gt0080

63. (6-cyclohexyl-1-hydroxy-4-methyl-2(1h)-pyridone)

64. Spbio_000252

65. Spbio_002502

66. Bpbio1_000641

67. Zinc1145

68. Ciclopirox [orange Book]

69. Ciclopirox, >=98% (hplc)

70. Dtxsid9048564

71. Bdbm66087

72. Gtpl11349

73. Kbio3_001261

74. Ciclopirox [ep Monograph]

75. Ciclopirox [usp Monograph]

76. Hms3656i12

77. Bcp28530

78. Hy-b0450

79. Mfcd00599441

80. S2528

81. Akos015895717

82. Ab06517

83. Ccg-266632

84. Db01188

85. Ks-5085

86. Ncgc00017112-04

87. Ncgc00017112-05

88. Ncgc00017112-06

89. Ncgc00017112-08

90. Ncgc00017112-11

91. Ncgc00178850-01

92. Ncgc00178850-02

93. Ac-24195

94. Ciclopirox 100 Microg/ml In Acetonitrile

95. Sbi-0206690.p002

96. Db-047566

97. Hoe 296; Hoe-296;ciclopiroxum; Penlac

98. 1-hydroxy-4-methyl-6-cyclohexyl-2-pyridone

99. Ft-0602961

100. Sw196923-5

101. 6-cyclohexyl-1-hydroxy-4-methyl-2-pyridinone

102. D03488

103. Ab00053438_09

104. Ab00053438_10

105. Ab00053438_11

106. 342c050

107. A819878

108. Q419468

109. Sr-05000001589-5

110. W-106995

111. 6-cyclohexyl-1-hydroxy-4-methyl-2(1h)-pyridinone #

112. Brd-k13044802-213-04-1

113. Brd-k13044802-213-09-0

114. 2-aminoethanol;6-cyclohexyl-1-hydroxy-4-methyl-2-pyridone

115. 6-cyclohexyl-1-hydroxy-4-methyl-1,2-dihydropyridin-2-one

116. Ciclopirox, European Pharmacopoeia (ep) Reference Standard

117. 2-aminoethanol;6-cyclohexyl-1-hydroxy-4-methyl-2-pyridinone

118. 2-azanylethanol;6-cyclohexyl-4-methyl-1-oxidanyl-pyridin-2-one

119. Ciclopirox, United States Pharmacopeia (usp) Reference Standard

2.4 Create Date

2005-03-25

3 Chemical and Physical Properties

Molecular Formula	C₁₂H₁₇NO₂
Molecular Weight	207.27 g/mol
XLogP3	2
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	2
Rotatable Bond Count	1
Exact Mass	207.125928785 g/mol
Monoisotopic Mass	207.125928785 g/mol
Topological Polar Surface Area	40.5 Å²
Heavy Atom Count	15
Formal Charge	0
Complexity	325
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

4 Drug and Medication Information

4.1 Drug Information

1 of 6
Drug Name	Ciclopirox
PubMed Health	Ciclopirox (On the skin)
Drug Classes	Antifungal
Drug Label	Ciclopirox Topical Solution, 8% (Nail Lacquer) contains a synthetic antifungal agent, ciclopirox. It is intended for topical use on fingernails and toenails and immediately adjacent skin.Each gram of Ciclopirox Topical Solution, 8% (Nail Lacquer) con...
Active Ingredient	Ciclopirox
Dosage Form	Gel; Shampoo; Cream; Solution; Suspension
Route	Topical
Strength	8%; 1%; 0.77%
Market Status	Prescription
Company	Glenmark Generics; Fougera Pharms; Glenmark Pharms; Hi Tech Pharma; Paddock; Versapharm; Actavis Mid Atlantic; Perrigo; Perrigo New York; Taro Pharm Inds; Taro; Tolmar; G And W Labs; Cipla

2 of 6
Drug Name	Loprox
PubMed Health	Ciclopirox (On the skin)
Drug Classes	Antifungal
Drug Label	LOPROX (ciclopirox) Shampoo 1% contains the synthetic antifungal agent, ciclopirox for topical use.Each gram (equivalent to 0.96 mL) of LOPROX Shampoo contains 10 mg ciclopirox in a shampoo base consisting of disodium laureth sulfosuccinate, laureth-...
Active Ingredient	Ciclopirox
Dosage Form	Shampoo; Cream; Suspension; Gel
Route	Topical
Strength	1%; 0.77%
Market Status	Prescription
Company	Cnty Line Pharms; Medicis; Medimetriks Pharms

3 of 6
Drug Name	Penlac
Drug Label	PENLAC NAIL LACQUER (ciclopirox) Topical Solution, 8%, contains a synthetic antifungal agent, ciclopirox. It is intended for topical use on fingernails and toenails and immediately adjacent skin. Each gram of PENLAC NAIL LACQUER (ciclopirox) Topi...
Active Ingredient	Ciclopirox
Dosage Form	Solution
Route	Topical
Strength	8%
Market Status	Prescription
Company	Valeant Bermuda

4 of 6
Drug Name	Ciclopirox
PubMed Health	Ciclopirox (On the skin)
Drug Classes	Antifungal
Drug Label	Ciclopirox Topical Solution, 8% (Nail Lacquer) contains a synthetic antifungal agent, ciclopirox. It is intended for topical use on fingernails and toenails and immediately adjacent skin.Each gram of Ciclopirox Topical Solution, 8% (Nail Lacquer) con...
Active Ingredient	Ciclopirox
Dosage Form	Gel; Shampoo; Cream; Solution; Suspension
Route	Topical
Strength	8%; 1%; 0.77%
Market Status	Prescription
Company	Glenmark Generics; Fougera Pharms; Glenmark Pharms; Hi Tech Pharma; Paddock; Versapharm; Actavis Mid Atlantic; Perrigo; Perrigo New York; Taro Pharm Inds; Taro; Tolmar; G And W Labs; Cipla

5 of 6
Drug Name	Loprox
PubMed Health	Ciclopirox (On the skin)
Drug Classes	Antifungal
Drug Label	LOPROX (ciclopirox) Shampoo 1% contains the synthetic antifungal agent, ciclopirox for topical use.Each gram (equivalent to 0.96 mL) of LOPROX Shampoo contains 10 mg ciclopirox in a shampoo base consisting of disodium laureth sulfosuccinate, laureth-...
Active Ingredient	Ciclopirox
Dosage Form	Shampoo; Cream; Suspension; Gel
Route	Topical
Strength	1%; 0.77%
Market Status	Prescription
Company	Cnty Line Pharms; Medicis; Medimetriks Pharms

6 of 6
Drug Name	Penlac
Drug Label	PENLAC NAIL LACQUER (ciclopirox) Topical Solution, 8%, contains a synthetic antifungal agent, ciclopirox. It is intended for topical use on fingernails and toenails and immediately adjacent skin. Each gram of PENLAC NAIL LACQUER (ciclopirox) Topi...
Active Ingredient	Ciclopirox
Dosage Form	Solution
Route	Topical
Strength	8%
Market Status	Prescription
Company	Valeant Bermuda

4.2 Drug Indication

Used as a topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophyton rubrum.

FDA Label

5 Pharmacology and Biochemistry

5.1 Pharmacology

Ciclopirox is a broad-spectrum antifungal medication that also has antibacterial and anti-inflammatory properties. Its main mode of action is thought to be its high affinity for trivalent cations, which inhibit essential co-factors in enzymes. Ciclopirox exhibits either fungistatic or fungicidal activity in vitro against a broad spectrum of fungal organisms, such as dermatophytes, yeasts, dimorphic fungi, eumycetes, and actinomycetes. In addition to its broad spectrum of action, ciclopirox also exerts antibacterial activity against many Gram-positive and Gram-negative bacteria. Furthermore, the anti-inflammatory effects of ciclopirox have been demonstrated in human polymorphonuclear cells, where ciclopirox has inhibited the synthesis of prostaglandin and leukotriene. Ciclopirox can also exhibit its anti-inflammatory effects by inhibiting the formation of 5-lipoxygenase and cyclooxygenase.

5.2 MeSH Pharmacological Classification

Antifungal Agents

Substances that destroy fungi by suppressing their ability to grow or reproduce. They differ from FUNGICIDES, INDUSTRIAL because they defend against fungi present in human or animal tissues. (See all compounds classified as Antifungal Agents.)

5.3 FDA Pharmacological Classification

5.3.1 Active Moiety

CICLOPIROX

5.3.2 FDA UNII

19W019ZDRJ

5.3.3 Pharmacological Classes

Decreased Protein Synthesis [PE]; Decreased RNA Replication [PE]; Protein Synthesis Inhibitors [MoA]; Decreased DNA Replication [PE]

5.4 ATC Code

D01AE14

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

D01 - Antifungals for dermatological use

D01A - Antifungals for topical use

D01AE - Other antifungals for topical use

D01AE14 - Ciclopirox

G - Genito urinary system and sex hormones

G01 - Gynecological antiinfectives and antiseptics

G01A - Antiinfectives and antiseptics, excl. combinations with corticosteroids

G01AX - Other antiinfectives and antiseptics

G01AX12 - Ciclopirox

5.5 Absorption, Distribution and Excretion

Absorption

Rapidly absorbed after oral administration. Mean absorption of ciclopirox after application to nails of all twenty digits and adjacent 5 millimeters of skin once daily for 6 months in patients with dermatophytic onychomycoses was less than 5% of the applied dose. Ciclopirox olamine also penetrates into hair and through the epidermis and hair follicles into sebaceous glands and dermis.

Route of Elimination

Most of the compound is excreted either unchanged or as glucuronide. After oral administration of 10 mg of radiolabeled drug (14C-ciclopirox) to healthy volunteers, approximately 96% of the radioactivity was excreted renally within 12 hours of administration. Ninety-four percent of the renally excreted radioactivity was in the form of glucuronides.

5.6 Metabolism/Metabolites

Glucuronidation is the main metabolic pathway of ciclopirox.

5.7 Biological Half-Life

1.7 hours for 1% topical solution.

5.8 Mechanism of Action

Unlike antifungals such as itraconazole and terbinafine, which affect sterol synthesis, ciclopirox is thought to act through the chelation of polyvalent metal cations, such as Fe³⁺ and Al³⁺. These cations inhibit many enzymes, including cytochromes, thus disrupting cellular activities such as mitochondrial electron transport processes and energy production. Ciclopirox also appears to modify the plasma membrane of fungi, resulting in the disorganization of internal structures. The anti-inflammatory action of ciclopirox is most likely due to inhibition of 5-lipoxygenase and cyclooxygenase. ciclopirox may exert its effect by disrupting DNA repair, cell division signals and structures (mitotic spindles) as well as some elements of intracellular transport.

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API Reference Price

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OLON SPA...","supplierCountry":"ITALY","foreign_port":"NA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"550","totalValueFC":"14967","currency":"EUR","unitRateINR":"49335","date":"21-Dec-2022","totalValueINR":"1233375","totalValueInUsd":"14967","indian_port":"BOMBAY AIR","hs_no":"29336990","bill_no":"3837708","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1671561000,"product":"CICLOPIROX OLAMINE USP (BATCH NO. 2250002964)","address":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:","city":"MUMBAI","supplier":"M\/S. OLON SPA...","supplierCountry":"ITALY","foreign_port":"NA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"175.00","actualQuantity":"175","unit":"KGS","unitRateFc":"550","totalValueFC":"104769","currency":"EUR","unitRateINR":"49335","date":"21-Dec-2022","totalValueINR":"8633625","totalValueInUsd":"104769","indian_port":"BOMBAY AIR","hs_no":"29336990","bill_no":"3837708","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1688322600,"product":"CICLOPIROX USP( (BATCH NO.A19556A)","address":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:","city":"MUMBAI","supplier":"INTERQUIM SA","supplierCountry":"SPAIN","foreign_port":"NA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"1250","totalValueFC":"13763.9","currency":"EUR","unitRateINR":"113124.7","date":"03-Jul-2023","totalValueINR":"1131249.819","totalValueInUsd":"13763.9","indian_port":"BOMBAY AIR","hs_no":"29337990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1688322600,"product":"CICLOPIROX USP( (BATCH NO.A19556A)","address":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:","city":"MUMBAI","supplier":"INTERQUIM SA","supplierCountry":"SPAIN","foreign_port":"NA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"1250","totalValueFC":"27527.8","currency":"EUR","unitRateINR":"113124.7","date":"03-Jul-2023","totalValueINR":"2262499.638","totalValueInUsd":"27527.8","indian_port":"BOMBAY AIR","hs_no":"29337990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1711477800,"product":"CICLOPIROX USP","address":"UNIT NO.24 STEEL MADE INDL.ESTATE","city":"MUMBAI","supplier":"SEQENS","supplierCountry":"FINLAND","foreign_port":"HELSINKI","customer":"ENCUBE ETHICALS PRIVATE LIMITED","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"800","totalValueFC":"89118.2","currency":"EUR","unitRateINR":"74000","date":"27-Mar-2024","totalValueINR":"7400000","totalValueInUsd":"89118.2","indian_port":"Bombay Air","hs_no":"29333990","bill_no":"2771108","productDescription":"API","marketType":"REGULATED MARKET","country":"FINLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"HELSINKI","supplierAddress":"PCAS FINLAND OYPO BOX 979FI-20101 TURKU FI","customerAddress":"UNIT NO.24 STEEL MADE INDL.ESTATE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1716316200,"product":"CICLOPIROX OLAMINE USP BATCH NO. 2350003226","address":"B\/2 MAHALAXMI CHAMBERS","city":"MUMBAI. MAHARASHTRA","supplier":"OLON S.P.A","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"550","totalValueFC":"15258.7","currency":"EUR","unitRateINR":"50875","date":"22-May-2024","totalValueINR":"1271875","totalValueInUsd":"15258.7","indian_port":"Bombay Air","hs_no":"29336990","bill_no":"3600809","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"STRADA RIVOLTANA KM. 6\/720053 RADANO (MI)ITALY IT","customerAddress":"B\/2 MAHALAXMI CHAMBERS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1716921000,"product":"CICLOPIROX OLAMINE USP (BATCH NO. 2350003226)","address":"B\/2 MAHALAXMI CHAMBERS","city":"MUMBAI. MAHARASHTRA","supplier":"OLON S.P.A","supplierCountry":"ITALY","foreign_port":"MILAN","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"3.64","actualQuantity":"3.64","unit":"KGS","unitRateFc":"550","totalValueFC":"2221.7","currency":"EUR","unitRateINR":"50875","date":"29-May-2024","totalValueINR":"185185","totalValueInUsd":"2221.7","indian_port":"Bombay Air","hs_no":"29336990","bill_no":"3728489","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN","supplierAddress":"STRADA RIVOLTANA KM. 6\/720053 RADANO (MI)ITALY IT","customerAddress":"B\/2 MAHALAXMI CHAMBERS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725474600,"product":"CICLOPIROX USP","address":"UNIT NO.24 STEEL MADE INDL.ESTATE","city":"MUMBAI","supplier":"PCAS","supplierCountry":"FINLAND","foreign_port":"HELSINKI","customer":"ENCUBE ETHICALS PRIVATE LIMITED","customerCountry":"INDIA","quantity":"6.47","actualQuantity":"6.47","unit":"KGS","unitRateFc":"800","totalValueFC":"5796.7","currency":"EUR","unitRateINR":"75080","date":"05-Sep-2024","totalValueINR":"485767.6","totalValueInUsd":"5796.7","indian_port":"Bombay Air","hs_no":"29333990","bill_no":"5433109","productDescription":"API","marketType":"REGULATED MARKET","country":"FINLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"HELSINKI","supplierAddress":"PO BOX 979 FI-20101 TURKU SDNF FI FI","customerAddress":"UNIT NO.24 STEEL MADE INDL.ESTATE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725474600,"product":"CICLOPIROX USP","address":"UNIT NO.24 STEEL MADE INDL.ESTATE","city":"MUMBAI","supplier":"PCAS","supplierCountry":"FINLAND","foreign_port":"HELSINKI","customer":"ENCUBE ETHICALS PRIVATE LIMITED","customerCountry":"INDIA","quantity":"124.00","actualQuantity":"124","unit":"KGS","unitRateFc":"800","totalValueFC":"111095.3","currency":"EUR","unitRateINR":"75080","date":"05-Sep-2024","totalValueINR":"9309920","totalValueInUsd":"111095.3","indian_port":"Bombay Air","hs_no":"29333990","bill_no":"5433109","productDescription":"API","marketType":"REGULATED MARKET","country":"FINLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"HELSINKI","supplierAddress":"PO BOX 979 FI-20101 TURKU SDNF FI FI","customerAddress":"UNIT NO.24 STEEL MADE INDL.ESTATE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1726425000,"product":"CICLOPIROX USP","address":"UNIT NO.24 STEEL MADE INDL.ESTATE","city":"MUMBAI","supplier":"PCAS","supplierCountry":"FINLAND","foreign_port":"HELSINKI","customer":"ENCUBE ETHICALS PRIVATE LIMITED","customerCountry":"INDIA","quantity":"130.62","actualQuantity":"130.62","unit":"KGS","unitRateFc":"800","totalValueFC":"118148.6","currency":"EUR","unitRateINR":"75800","date":"16-Sep-2024","totalValueINR":"9900996","totalValueInUsd":"118148.6","indian_port":"Bombay Air","hs_no":"29333990","bill_no":"5635971","productDescription":"API","marketType":"REGULATED MARKET","country":"FINLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"HELSINKI","supplierAddress":"PO BOX 979 FI-20101 TURKU SDNF FI","customerAddress":"UNIT NO.24 STEEL MADE INDL.ESTATE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729189800,"product":"CICLOPIROX","address":"UNIT NO.24 STEEL MADE INDL.ESTATE","city":"MUMBAI","supplier":"PCAS","supplierCountry":"FINLAND","foreign_port":"HELSINKI","customer":"ENCUBE ETHICALS PRIVATE LIMITED","customerCountry":"INDIA","quantity":"184.22","actualQuantity":"184.22","unit":"KGS","unitRateFc":"800","totalValueFC":"163027","currency":"EUR","unitRateINR":"74360","date":"18-Oct-2024","totalValueINR":"13698599.2","totalValueInUsd":"163027","indian_port":"Bombay Air","hs_no":"29333990","bill_no":"6191353","productDescription":"API","marketType":"REGULATED MARKET","country":"FINLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"HELSINKI","supplierAddress":"PO BOX 979 FI-20101 TURKU SDNF FI","customerAddress":"UNIT NO.24 STEEL MADE INDL.ESTATE"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

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

API Imports and Exports

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

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DOSAGE - CREAM;TOPICAL - 0.77%

USFDA APPLICATION NUMBER - 18748

DOSAGE - SUSPENSION;TOPICAL - 0.77%

USFDA APPLICATION NUMBER - 19824

DOSAGE - GEL;TOPICAL - 0.77% **Federal Regist...DOSAGE - GEL;TOPICAL - 0.77% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20519

DOSAGE - SOLUTION;TOPICAL - 8% **Federal Regi...DOSAGE - SOLUTION;TOPICAL - 8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21022

DOSAGE - SHAMPOO;TOPICAL - 1%

USFDA APPLICATION NUMBER - 21159

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01

Brand Name : Batrafen

France

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RX/OTC/DISCN : Class C

SANOFI-AVENTIS SpA

Ciclopirox

Dosage Form :

Dosage Strength : Cream Derm 30 G 1%

Price Per Pack (Euro) : 7.85

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Country : Italy

RX/OTC/DISCN : Class C

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02

Brand Name : Batrafen

France

Medlab Asia & Asia Health

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RX/OTC/DISCN : Class C

SANOFI-AVENTIS SpA

Ciclopirox

Dosage Form :

Dosage Strength : Skin Soluz 30 Ml 1%

Price Per Pack (Euro) : 7.85

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03

Brand Name : Micomicen

France

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RX/OTC/DISCN : Class C

SANOFI-AVENTIS SpA

Ciclopirox

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Dosage Strength : Cream Vag 78 G + 12 Applic

Price Per Pack (Euro) : 11.73

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04

Brand Name : Micomicen

France

Medlab Asia & Asia Health

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France

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RX/OTC/DISCN : Class C

SANOFI-AVENTIS SpA

Ciclopirox

Dosage Form :

Dosage Strength : 6 Ov Vag 100 Mg

Price Per Pack (Euro) : 11.73

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Country : Italy

RX/OTC/DISCN : Class C

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05

Brand Name : Micomicen

France

Medlab Asia & Asia Health

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France

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RX/OTC/DISCN : Class C

SANOFI-AVENTIS SpA

Ciclopirox

Dosage Form :

Dosage Strength : Ginec Foam 60 Ml 1%

Price Per Pack (Euro) : 10.2

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Country : Italy

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06

Brand Name : Batrafen

France

Medlab Asia & Asia Health

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France

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RX/OTC/DISCN : Class C

SANOFI-AVENTIS SpA

Ciclopirox

Dosage Form :

Dosage Strength : Skin Groun 30 G 1%

Price Per Pack (Euro) : 7.85

Published in :

Country : Italy

RX/OTC/DISCN : Class C

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07

Brand Name : Batrafen

France

Medlab Asia & Asia Health

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France

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RX/OTC/DISCN : Class C

SANOFI-AVENTIS SpA

Ciclopirox

Dosage Form :

Dosage Strength : Enamel Nails 1 Bottle 3 G 8%

Price Per Pack (Euro) : 27.03

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Country : Italy

RX/OTC/DISCN : Class C

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08

Brand Name : CICLOPIROX

U.S.A

Medlab Asia & Asia Health

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RX/OTC/DISCN : RX

TARO

Ciclopirox

Dosage Form : SUSPENSION;TOPICAL

Dosage Strength : 0.77%

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Country : USA

RX/OTC/DISCN : RX

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09

Brand Name : Brumixol

Italy

Medlab Asia & Asia Health

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10

Brand Name : Brumixol

Italy

Medlab Asia & Asia Health

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Ciclopirox

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ACTIVE PHARMA INGREDIENTS

10 API Suppliers

6 USDMF

5 CEP/COS

1 KDMF

5 NDC API

6 Listed Suppliers

$ API Reference Price

FINISHED DOSAGE FORMULATIONS

93 FDF Dossiers

32 FDA Orange Book

54 Europe

3 Canada

4 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CREAM;TOPICAL - 0.77%

SUSPENSION;TOPICAL - 0.77%

GEL;TOPICAL - 0.77% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SOLUTION;TOPICAL - 8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SHAMPOO;TOPICAL - 1%

RELATED EXCIPIENT COMPANIES

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2 Lubrizol Life Science Health

1 Pluviaendo

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6 Parenteral

5 Solubilizers

3 Granulation

3 Coating Systems & Additives

3 Thickeners and Stabilizers

3 Film Formers & Plasticizers

2 Lubricants & Glidants

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3 USP

6 Others

ACTIVE PHARMA INGREDIENTS

API REF. PRICE (USD/KG)

$ 382

MARKET PLACE

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FINISHED DOSAGE FORMULATIONS

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GEL;TOPICAL - 0.77% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SOLUTION;TOPICAL - 8% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons