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Also known as: 164650-44-6, (2r,3r)-2-(2,4-difluorophenyl)-3-(4-methylenepiperidin-1-yl)-1-(1h-1,2,4-triazol-1-yl)butan-2-ol, Kp-103, Jublia, Clenafin, Kp103
Molecular Formula
C18H22F2N4O
Molecular Weight
348.4  g/mol
InChI Key
NFEZZTICAUWDHU-RDTXWAMCSA-N
FDA UNII
J82SB7FXWB

Efinaconazole
Efinaconazole is a triazole compound, with antifungal activity. Upon administration, efinaconazole targets, binds to and inhibits 14-alpha-demethylase, a cytochrome P450-dependent enzyme. Inhibition of 14-alpha-demethylase prevents the conversion of lanosterol to ergosterol, an important component of the fungal cell wall. Inhibition of ergosterol synthesis changes the fungal cell membrane composition and integrity, alters membrane permeability and eventually leads to fungal cell lysis.
Efinaconazole is an Azole Antifungal.
1 2D Structure

Efinaconazole

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2R,3R)-2-(2,4-difluorophenyl)-3-(4-methylidenepiperidin-1-yl)-1-(1,2,4-triazol-1-yl)butan-2-ol
2.1.2 InChI
InChI=1S/C18H22F2N4O/c1-13-5-7-23(8-6-13)14(2)18(25,10-24-12-21-11-22-24)16-4-3-15(19)9-17(16)20/h3-4,9,11-12,14,25H,1,5-8,10H2,2H3/t14-,18-/m1/s1
2.1.3 InChI Key
NFEZZTICAUWDHU-RDTXWAMCSA-N
2.1.4 Canonical SMILES
CC(C(CN1C=NC=N1)(C2=C(C=C(C=C2)F)F)O)N3CCC(=C)CC3
2.1.5 Isomeric SMILES
C[C@H]([C@](CN1C=NC=N1)(C2=C(C=C(C=C2)F)F)O)N3CCC(=C)CC3
2.2 Other Identifiers
2.2.1 UNII
J82SB7FXWB
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Jublia

2. Kp 103

3. Kp-103

4. Kp103

2.3.2 Depositor-Supplied Synonyms

1. 164650-44-6

2. (2r,3r)-2-(2,4-difluorophenyl)-3-(4-methylenepiperidin-1-yl)-1-(1h-1,2,4-triazol-1-yl)butan-2-ol

3. Kp-103

4. Jublia

5. Clenafin

6. Kp103

7. Idp-108

8. J82sb7fxwb

9. 164905-19-5

10. Chebi:82718

11. (2r,3r)-2-(2,4-difluorofenil)-3-(4-metilenopiperidin-1-il)-1-(1h-1,2,4-triazin-1-il)butan-2-ol

12. (2r,3r)-2-(2,4-difluorophenyl)-3-(4-methylidenepiperidin-1-yl)-1-(1,2,4-triazol-1-yl)butan-2-ol

13. Efinaconazole [inn]

14. Kp 103

15. Unii-j82sb7fxwb

16. Efinaconazole [usan:inn]

17. Efinaconazol

18. Efinaconazolum

19. Clenafin (tn)

20. Jublia (tn)

21. Efinaconazole(kp-103)

22. Efinaconazole; Kp-103

23. Efinaconazole [mi]

24. Efinaconazole [jan]

25. Efinaconazole [usan]

26. Efinaconazole [vandf]

27. Schembl300738

28. Efinaconazole [who-dd]

29. Zinc6251

30. Chembl2103877

31. Efinaconazole (jan/usan/inn)

32. Hsdb 8341

33. Dtxsid40167787

34. Efinaconazole [orange Book]

35. Bcp11665

36. Ex-a2643

37. Mfcd00936406

38. S5025

39. Akos027323571

40. Ccg-268012

41. Cs-3500

42. Db09040

43. Ncgc00390702-01

44. Ncgc00390702-02

45. Ncgc00390702-03

46. Ac-30630

47. As-30126

48. Hy-15660

49. D10021

50. A854585

51. Q21011225

52. (2r, 3r)-2-(2,4-difluorophenyl)-3-(4-methylenepiperidyl)-1-(1,2,4-triazolyl)butan-2-ol

53. (2r,3r)-2-(2,4-difluorophenyl)-3-(4-methylene-1-piperidinyl)-1-(1h-1,2,4-triazol-1-yl)-2-butanol

54. (2r,3r)-2-(2,4-difluorophenyl)-3-(4-methylene-1-piperidyl)-1-(1,2,4-triazol-1-yl)butan-2-ol

55. (2r,3r)-2-(2,4-difluorophenyl)-3-(4-methylenepiperidine-1-yl)-1-(1h-1,2,4-triazole-1-yl)butane-2-ol

56. (2r,3r)-2-(2,4-difluorophenyl)-3-(4-methylenepiperidino)-1-(1h-1,2,4-triazol-1-yl)butan-2-ol

57. (alphar,betar)-alpha-(2,4-difluorophenyl)-beta-methyl-4-methylene-alpha-(1h-1,2,4-triazol-1-ylmethyl)-1-piperidineethanol

58. 1-piperidineethanol, .alpha.-(2,4-difluorophenyl)-.beta.-methyl-4-methylene-.alpha.-(1h-1,2,4-triazol-1-ylmethyl)-, (r-(r*,r*))-

59. 1-piperidineethanol, .alpha.-(2,4-difluorophenyl)-.beta.-methyl-4-methylene-.alpha.-(1h-1,2,4-triazol-1-ylmethyl)-,(.alpha.r,.beta.r)-

60. 1-piperidineethanol, Alpha-(2,4-difluorophenyl)-beta-methyl-4-methylene-alpha-(1h-1,2,4-triazol-1- Ylmethyl)-, (alphar,betar)-

61. 1-piperidineethanol, Alpha-(2,4-difluorophenyl)-beta-methyl-4-methylene-alpha-(1h-1,2,4-triazol-1-ylmethyl)-, (alphar,betar)-

2.4 Create Date
2005-08-01
3 Chemical and Physical Properties
Molecular Weight 348.4 g/mol
Molecular Formula C18H22F2N4O
XLogP32
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count6
Rotatable Bond Count5
Exact Mass348.17616766 g/mol
Monoisotopic Mass348.17616766 g/mol
Topological Polar Surface Area54.2 Ų
Heavy Atom Count25
Formal Charge0
Complexity470
Isotope Atom Count0
Defined Atom Stereocenter Count2
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Therapeutic Uses

Antifungal Agents

National Library of Medicine's Medical Subject Headings. Efinaconazole. Online file (MeSH, 2016). Available from, as of June 24, 2016: https://www.nlm.nih.gov/mesh/2016/mesh_browser/MBrowser.html


Jublia (efinaconazole) topical solution, 10% is an azole antifungal indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes. /Included in US product label/

NIH; DailyMed. Current Medication Information for Jublia (Efinaconazole) Solution (Updated: May 2016). Available from, as of July 5, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=922d4d25-c530-11e1-9b21-0800200c9a66


We sought to evaluate the efficacy of efinaconazole topical solution, 10%, in patients with onychomycosis and coexisting tinea pedis. We analyzed 1,655 patients, aged 18 to 70 years, randomized (3:1) to receive efinaconazole topical solution, 10%, or vehicle from two identical multicenter, double-blind, vehicle-controlled 48-week studies evaluating safety and efficacy. The primary end point was complete cure rate (0% clinical involvement of the target toenail and negative potassium hydroxide examination and fungal culture findings) at week 52. Three groups were compared: patients with onychomycosis and coexisting interdigital tinea pedis on-study (treated or left untreated) and those with no coexisting tinea pedis. Treatment with efinaconazole topical solution, 10%, was significantly more effective than vehicle use irrespective of the coexistence of tinea pedis or its treatment. Overall, 352 patients with onychomycosis (21.3%) had coexisting interdigital tinea pedis, with 215 of these patients (61.1%) receiving investigator-approved topical antifungal agents for their tinea pedis in addition to their randomized onychomycosis treatment. At week 52, efinaconazole complete cure rates of 29.4% were reported in patients with onychomycosis when coexisting tinea pedis was treated compared with 16.1% when coexisting tinea pedis was not treated. Both cure rates were significant compared with vehicle (p = 0.003 and 0.045, respectively), and in the latter subgroup, no patients treated with vehicle achieved a complete cure. Treatment of coexisting tinea pedis in patients with onychomycosis enhances the efficacy of once-daily topical treatment with efinaconazole topical solution, 10%.

PMID:26429609 Markinson B, Caldwell B; J Am Podiatr Med Assoc 105 (5): 407-11 (2015)


A number of comorbidities and risk factors complicate the successful management of onychomycosis. Underlying conditions and patient characteristics, such as tinea pedis, age, and obesity, contribute to risk, whereas comorbidities, such as diabetes and psoriasis, can increase susceptibility to the disease. There are limited data on treatment effectiveness in these patients. Here, the authors review post hoc analyses of efinaconazole topical solution, 10%, in mild-to-moderate onychomycosis and present new data in terms of age and obesity. The only post hoc analysis to report significant differences so far is gender, where female patients do much better; however, the reasons are unclear. The authors report significant differences in terms of efficacy in obese patients who do not respond as well as those with normal body mass index (p=0.05) and in patients who have their co-existing tinea pedis treated compared to those in whom co-existing tinea pedis was not treated (p=0.025). Although there is a trend to reduced efficacy in older patients and those with co-existing diabetes, differences were not significant. More research is needed in onychomycosis patients with these important risk factors and comorbidities to fully evaluate the treatment challenges and possible solutions.

PMID:26705439 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4689496 Elewski BE, Tosti A; J Clin Aesthet Dermatol 8 (11): 38-42 (2015)


Onychomycosis is a common fungal infection of the nail unit that results in discoloration, subungual debris, thickening, onycholysis, and often pain and impairment of mobility. Dermatophytomas are characterized by a thick fungal mass within and under the nail plate and are especially resistant to treatment. Here we report a case of a patient with a dermatophytoma who had failed oral terbinafine but was successfully treated with efinaconazole 10% topical solution.

PMID:25942674 Cantrell W et al; J Drugs Dermatol 14 (5): 524-6 (2015)


4.2 Drug Warning

Adverse effects reported in at least 1% of adults treated with efinaconazole 10% topical solution and more frequently than with topical vehicle solution include application site dermatitis, ingrown toenail, application site vesicles, and application site pain.

American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016


Prior to treatment of onychomycosis, the diagnosis should be confirmed by direct microscopic examination of scrapings from infected toenails mounted in potassium hydroxide (KOH) or by culture.

American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016


Efinaconazole 10% solution is for topical use only. The topical solution should not be used orally or intravaginally, and should not be applied to the eyes.

American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016


Efinaconazole 10% topical solution may cause application site irritation (e.g., redness, swelling, burning, itching, blisters); there is no evidence to date that the solution causes contact sensitization.

American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016


For more Drug Warnings (Complete) data for Efinaconazole (10 total), please visit the HSDB record page.


4.3 Drug Indication

Indicated in the treatment of fungal infection of the nail, known as onychomycosis.


FDA Label


Treatment of onychomycosis


5 Pharmacology and Biochemistry
5.1 Pharmacology

mean SD plasma Cmax on Day 28 of treatment: 0.67 0.37 ng/mL. mean SD AUC was 12.15 6.91 ng*h/mL.


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
EFINACONAZOLE
5.3.2 FDA UNII
J82SB7FXWB
5.3.3 Pharmacological Classes
Azoles [CS]; Azole Antifungal [EPC]
5.4 ATC Code

D - Dermatologicals

D01 - Antifungals for dermatological use

D01A - Antifungals for topical use

D01AC - Imidazole and triazole derivatives

D01AC19 - Efinaconazole


5.5 Absorption, Distribution and Excretion

Administration of Jublia by the topical route leads to low systemic efinaconazole concentrations. Systemic absorption of efinaconazole in 18 patients with severe onychomycosis was determined after application of Jublia once daily for 28 days to patients' 10 toenails and adjacent skin. The concentration of efinaconazole in plasma was determined at multiple time points over the course of 24-hour periods on days 1, 14, and 28. Efinaconazole mean plasma Cmax on Day 28 was 0.67 ng/mL. The mean plasma concentration versus time profile was generally flat over the course of treatment. In onychomycosis patients, the steady state plasma concentration range was 0.1-1.5 ng/mL for efinaconazole and 0.2-7.5 ng/mL for H3 metabolite.

Health Canada; Product Monograph for Jublia (Efinaconazole) Topical Solution, 10% w/w, Drug Identification Number (DIN): 02413388 p.9 (Date of Preparation: October 2, 2013). Available from, as of July 5, 2016: https://webprod5.hc-sc.gc.ca/dpd-bdpp/start-debuter.do?lang=eng


/MILK/ Efinaconazole and or its metabolites were excreted in milk from lactating rats. The radioactivity concentration in milk was higher than that in plasma concentration for 24 hours after the administration of 14C-efinaconazole to lactating rats. However, the elimination half-life of the milk radioactivity was about one half of that of the plasma radioactivity, suggesting that efinaconazole or its metabolites was not retained in milk.

Health Canada; Product Monograph for Jublia (Efinaconazole) Topical Solution, 10% w/w, Drug Identification Number (DIN): 02413388 p.17 (Date of Preparation: October 2, 2013). Available from, as of July 5, 2016: https://webprod5.hc-sc.gc.ca/dpd-bdpp/start-debuter.do?lang=eng


/MILK/ It is not known whether efinaconazole is excreted in human milk.

NIH; DailyMed. Current Medication Information for Jublia (Efinaconazole) Solution (Updated: May 2016). Available from, as of July 5, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=922d4d25-c530-11e1-9b21-0800200c9a66


Efinaconazole penetrates through nails in vitro after Jublia administration, suggesting drug penetrations to the site of fungal infection in the nail and the nail bed, though clinical relevance is unknown. The penetration of Jublia was evaluated in an in vitro investigation after daily application of radiolabelled efinaconazole (10%) to human nails for 28 days at 55.1 uL/sq cm. After 28 days, the cumulative radioactivity in the receptor fluid and in the nail plate, on a percent basis of total administered radioactivity, was 0.03% and 0.16% (3.11 mg eq/g), respectively. The flux rate was relatively constant from Days 18 to 28, mean 1.40 ug eq/sq cm/day, suggesting steady state attainment.

Health Canada; Product Monograph for Jublia (Efinaconazole) Topical Solution, 10% w/w, Drug Identification Number (DIN): 02413388 p.9 (Date of Preparation: October 2, 2013). Available from, as of July 5, 2016: https://webprod5.hc-sc.gc.ca/dpd-bdpp/start-debuter.do?lang=eng


For more Absorption, Distribution and Excretion (Complete) data for Efinaconazole (8 total), please visit the HSDB record page.


5.6 Metabolism/Metabolites

Efinaconazole is extensively metabolized. It is oxidatively metabolized, cleaved and conjugated to glucuronic acid. The studies have identified 5 metabolites (H1, H2, H3, H4 and H5) of efinaconazole. In rats and minipigs, H3 was the major efinaconazole plasma metabolite, and its levels usually equaled or exceeded those of parent drug. The in vitro and in vivo metabolite profiles in nonclinical species were similar to human with no unique human metabolite(s).

Health Canada; Product Monograph for Jublia (Efinaconazole) Topical Solution, 10% w/w, Drug Identification Number (DIN): 02413388 p.17 (Date of Preparation: October 2, 2013). Available from, as of July 5, 2016: https://webprod5.hc-sc.gc.ca/dpd-bdpp/start-debuter.do?lang=eng


Jublia (efinaconazole) is extensively metabolized through oxidative/reductive processes, with the potential of additional metabolite glucuronidation. Analysis of human plasma confirmed that H3 is the only major efinaconazole metabolite.

Health Canada; Product Monograph for Jublia (Efinaconazole) Topical Solution, 10% w/w, Drug Identification Number (DIN): 02413388 p.10 (Date of Preparation: October 2, 2013). Available from, as of July 5, 2016: https://webprod5.hc-sc.gc.ca/dpd-bdpp/start-debuter.do?lang=eng


Efinaconazole metabolites, but not parent drug, were excreted in the bile and urine of rats and dogs which suggests complete metabolism of efinaconazole prior to excretion. Most of the absorbed radioactivity was eliminated during the first 72 hours after dermal and SC dosing in urine and feces.

Health Canada; Product Monograph for Jublia (Efinaconazole) Topical Solution, 10% w/w, Drug Identification Number (DIN): 02413388 p.17 (Date of Preparation: October 2, 2013). Available from, as of July 5, 2016: https://webprod5.hc-sc.gc.ca/dpd-bdpp/start-debuter.do?lang=eng


5.7 Biological Half-Life

29.9 hours in healthy patients.


In a ... study of healthy volunteers, the plasma half-life of Jublia at day 10 following repeat treatment applications repeated to all 10 toenails was 29.9 hours.

Health Canada; Product Monograph for Jublia (Efinaconazole) Topical Solution, 10% w/w, Drug Identification Number (DIN): 02413388 p.9 (Date of Preparation: October 2, 2013). Available from, as of July 5, 2016: https://webprod5.hc-sc.gc.ca/dpd-bdpp/start-debuter.do?lang=eng


5.8 Mechanism of Action

Efinaconazole is an azole antifungal. Efinaconazole inhibits fungal lanosterol 14-demethylase involved in the biosynthesis of ergosterol, a constituent of fungal cell membranes.


Efinaconazole is a triazole antifungal agent. Efinaconazole inhibits fungal lanosterol 14alpha-demethylase involved in ergosterol biosynthesis. The accumulation of 14alpha-methyl sterols and subsequent loss of ergosterol in the fungi cell wall may be responsible for the fungistatic and fungicidal activity of efinaconazole. Efinaconazole is shown in vitro to be substantially adsorbed to keratin but keratin binding is weak. Efinaconazole's low keratin affinity is expected to result in increased availability of free drug to the nail infection site.

Health Canada; Product Monograph for Jublia (Efinaconazole) Topical Solution, 10% w/w, Drug Identification Number (DIN): 02413388 p.9 (Date of Preparation: October 2, 2013). Available from, as of July 5, 2016: https://webprod5.hc-sc.gc.ca/dpd-bdpp/start-debuter.do?lang=eng


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Efinaconazole

Registrant Name : Toru Corporation

Registration Date : 2023-02-21

Registration Number : Su434-16-ND(2)

Manufacturer Name : Virupaksha Organics Ltd

Manufacturer Address : Sy. No.10, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telangana Sta...

Virupaksha

02

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Efinaconazole

Registrant Name : Aging Life Science Co., Ltd.

Registration Date : 2020-07-14

Registration Number : Su434-16-ND

Manufacturer Name : Virupaksha Organics Limited ...

Manufacturer Address : Sy. No.10, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telangana Sta...

Virupaksha

03

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Efinaconazole

Registrant Name : Klasia Co., Ltd.

Registration Date : 2020-09-04

Registration Number : Su434-16-ND(1)

Manufacturer Name : Virupaksha Organics Limited ...

Manufacturer Address : Sy. No.10, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telangana Sta...

Virupaksha

04

Cipla

India
Medlab Asia & Asia Health
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Cipla

India
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Efinaconazole

Registrant Name : Hiple Co., Ltd.

Registration Date : 2022-04-27

Registration Number : No. 496-27-ND(1)

Manufacturer Name : Cipla Limited.

Manufacturer Address : Plot NOS. A-2, A-33 & A-37/2/2, MIDC, Patalganga, Raigad 410220 Maharashtra State, In...

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05

Cipla

India
Medlab Asia & Asia Health
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Cipla

India
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Efinaconazole

Registrant Name : Dongwha Pharmaceutical Co., Ltd.

Registration Date : 2022-08-03

Registration Number : No. 496-27-ND(2)

Manufacturer Name : Cipla Limited.

Manufacturer Address : Plot NOS. A-2, A-33 & A-37/2/2, MIDC, Patalganga, Raigad 410220 Maharashtra State, In...

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06

Daebong

South Korea
Medlab Asia & Asia Health
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Daebong

South Korea
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Efinaconazole

Registrant Name : Daebong LS Co., Ltd.

Registration Date : 2021-07-13

Registration Number : 1867-4-ND

Manufacturer Name : Daebong LS Co., Ltd.

Manufacturer Address : 122B-9L, 123, Neungheodae-ro 649beon-gil, Namdong-gu, Incheon

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07

Medlab Asia & Asia Health
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Efinaconazole

Registrant Name : M-Peak Korea Co., Ltd.

Registration Date : 2021-11-10

Registration Number : Number 812-16-ND

Manufacturer Name : Glenmark Life Sciences Ltd

Manufacturer Address : Plot No.Z-103/ I, DAHEJ SEZ Phase II, City : Dahej, District : Bharuch, Gujarat State...

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08

Medlab Asia & Asia Health
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Efinaconazole

Registrant Name : Ace Biopharm Co., Ltd.

Registration Date : 2021-03-23

Registration Number : Su289-8-ND

Manufacturer Name : Harman Finochem Limited

Manufacturer Address : A-100, A-100/1, A-100/2 & D-1, MIDC Industrial Area, Shendra, Aurangabad -431 007, Ma...

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09

Medlab Asia & Asia Health
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Efinaconazole

Registrant Name : Dong-A ST Co., Ltd.

Registration Date : 2022-09-01

Registration Number : Number 247-17-ND

Manufacturer Name : Kaneka Corporation Takasago ...

Manufacturer Address : 1-8, Miyamae-machi, Takasago-cho, Takasago, Hyogo 676-8688, Japan

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10

Procos

Italy
Medlab Asia & Asia Health
Not Confirmed
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Procos

Italy
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Efinaconazole

Registrant Name : Sungjin Exim Co., Ltd.

Registration Date : 2021-02-05

Registration Number : 133-12-ND

Manufacturer Name : Procos SpA

Manufacturer Address : Via Matteotti 249-28062 Cameri (NO) Italy

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NDC API

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01

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EFINACONAZOLE

NDC Package Code : 51686-0012

Start Marketing Date : 2007-10-16

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

Virupaksha

02

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Virtual BoothSeqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

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EFINACONAZOLE

NDC Package Code : 58175-0606

Start Marketing Date : 2015-05-15

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

Seqens Company Banner

03

Medlab Asia & Asia Health
Not Confirmed
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EFINACONAZOLE

NDC Package Code : 46438-0644

Start Marketing Date : 2005-10-13

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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04

Medlab Asia & Asia Health
Not Confirmed
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EFINACONAZOLE

NDC Package Code : 66039-930

Start Marketing Date : 2016-09-30

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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Medlab Asia & Asia Health
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EFINACONAZOLE

NDC Package Code : 51557-001

Start Marketing Date : 2014-06-06

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER, FOR SOLUTION (1kg/kg)

Marketing Category : BULK INGREDIENT

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EFINACONAZOLE

NDC Package Code : 66064-1024

Start Marketing Date : 2017-01-01

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (10kg/10kg)

Marketing Category : BULK INGREDIENT

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EFINACONAZOLE

NDC Package Code : 70600-001

Start Marketing Date : 2016-03-31

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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EFINACONAZOLE

NDC Package Code : 68259-1314

Start Marketing Date : 2014-07-20

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER, FOR SOLUTION (1kg/kg)

Marketing Category : BULK INGREDIENT

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09

Medlab Asia & Asia Health
Not Confirmed
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EFINACONAZOLE

NDC Package Code : 76397-006

Start Marketing Date : 2020-01-01

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (1g/g)

Marketing Category : BULK INGREDIENT

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EFINACONAZOLE

NDC Package Code : 76397-018

Start Marketing Date : 2018-01-01

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT FOR HUMAN P...

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Listed Suppliers

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Efinaconazole

About the Company : Virupaksha Organics, founded in 2003 by G. Chandra Mouliswar Reddy, is committed to delivering products of the utmost quality to its customers. In a span of less than 20 years, the...

Virupaksha Organics, founded in 2003 by G. Chandra Mouliswar Reddy, is committed to delivering products of the utmost quality to its customers. In a span of less than 20 years, the Hyderabad-based company has grown from a single manufacturing unit to four, employing over 1,000 people. The manufacturing units are situated in Kazipally, Pashamylaram, Humnabad and Gandhi Nagar. Virupaksha's manufacturing facility holds FDA approval, reflecting its adherence to stringent standards. With a customer base exceeding 300 and a presence spanning over 70 countries, Virupaksha has established itself as a reputable global player in its field.
Virupaksha

02

LGM Pharma

U.S.A
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Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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Efinaconazole

About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.
LGM Pharma CB

03

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Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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Efinaconazole

About the Company :

Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product ...

Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product groups and has been approved by ISO 9001-2015, USFDA, WHO GMP, Cofepris & Japanese authorities. Metrochem’s in-depth industry knowledge, & hi-tech & advanced infrastructure, helps it provide quality products to its customers. Note: None of the products will be supplied to the countries where this could 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
Metrochem

04

Seqens

France
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Virtual BoothSeqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

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Efinaconazole

About the Company : Since its inception in 2003, Seqens has grown to become a global leader in pharmaceutical solutions and specialty ingredients. Seqens supports its customers in developing, scaling ...

Since its inception in 2003, Seqens has grown to become a global leader in pharmaceutical solutions and specialty ingredients. Seqens supports its customers in developing, scaling up and manufacturing drug substances from the pre-clinical phase to the commercial phase. It offers a large portfolio of APIs and proprietary products. Seqens also develops custom solutions and ingredients for the most demanding industries, such as healthcare, electronics and cosmetics. Its unique range of technologies enables it to manufacture complex molecules for small- and large-scale demands. It operates 24 industrial plants and 10 R&D centres across the globe.
Seqens Company Banner

05

Dipharma

Italy
Medlab Asia & Asia Health
Not Confirmed
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Dipharma

Italy
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Efinaconazole

About the Company : Dipharma is a leading European manufacturer of Active Pharmaceutical Ingredients that has been developing innovative and proprietary processes since 1949. We support our custome...

Dipharma is a leading European manufacturer of Active Pharmaceutical Ingredients that has been developing innovative and proprietary processes since 1949. We support our customers worldwide with a strong and well resourced R&D team, three cGMP facilities in Europe, and offer world-renowned expertise in handling hazardous chemical processes. Our customers can benefit from our broad portfolio of generic Active Pharmaceutical Ingredients and a wide range of advanced technologies available for custom synthesis. They can rely on the highest quality standards, but it does not stop there, they can count on our experience in innovation.
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Efinaconazole

About the Company : Harman Finochem Limited is a leading India-based Pharmaceutical Company which specializes in the manufacture and export of more than 45 Active Pharmaceutical Ingredients (APls) of ...

Harman Finochem Limited is a leading India-based Pharmaceutical Company which specializes in the manufacture and export of more than 45 Active Pharmaceutical Ingredients (APls) of which 10 are Essential Drugs as per the WHO Model List. We deliver top quality products to more than 35 countries across the globe. Harman Finochem ensures that its customers worldwide are delighted by receiving APl’s which are safe, efficient and of highest quality. We adhere to principles of cGmp and our team at all levels is committed to achieving this corporate excellence goal.
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Efinaconazole

About the Company : Maithri Drugs is one of India's fast-growing pharmaceutical companies. Maithri's strategic focus is on active pharma ingredients (APIs). The company is widely recognized for its ex...

Maithri Drugs is one of India's fast-growing pharmaceutical companies. Maithri's strategic focus is on active pharma ingredients (APIs). The company is widely recognized for its excellent research & development and aggressive growth strategies. Our 32 US DMFs and 9 CEPs in a short span attest to our R&D excellence. Maithri's manufacturing facility is located in Hyderabad. This facility is audited and approved by the US FDA. In addition, our facility is certified according to the standards of DCGI, WHO GMP, and ISO 9001:2015 We have a portfolio of 65 products and are continually expanding.
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Nifty Labs

India
Medlab Asia & Asia Health
Not Confirmed
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Nifty Labs

India
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Efinaconazole

About the Company : The company was founded by a technocrat Mr. D. Kesava Reddy in the year 2005. The Managing Director Mr. D. Kesava Reddy along with other three Board of Directors involved in contro...

The company was founded by a technocrat Mr. D. Kesava Reddy in the year 2005. The Managing Director Mr. D. Kesava Reddy along with other three Board of Directors involved in controlling the day to day operations of the company. The company has been focused on manufacturing and marketing of Bulk APIs (Bulk Drugs) and key Intermediates for APIs for Domestic and Global markets. About 60% is catered to domestic market and the rest 40% is catered to exports. The company does have a sister company named “Nifty Pharma Pvt. Ltd. located in Hyderabad focused on manufacturing & marketing of Semi-finished dosage forms.
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Medlab Asia & Asia Health
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Efinaconazole

About the Company : Synergene Active Ingredients Pvt.Ltd was incorporated in 2006 and commercial operations began in the same year. The Company is a manufacturer and supplier of Active Pharmaceuticals...

Synergene Active Ingredients Pvt.Ltd was incorporated in 2006 and commercial operations began in the same year. The Company is a manufacturer and supplier of Active Pharmaceuticals Ingredients (API'S) for wide range of therapeutic categories. Therapeutic segments of focus are Anti Fungals, Anti Depressants, and Anti Hypertensive. Synergene manufacturing facilities are cGMP compliant meeting global standards in terms of infrastructure and systems. The company has two manufacturing facilities located at Hyderabad & Vishakhapatnam manufacturing Active Pharmaceutical Ingredients and Intermediates.
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Not Confirmed
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Efinaconazole

About the Company : Viwit Pharmaceuticals Limited (Viwit), founded in 2006, is a fast-growing research-based pharmaceutical healthcare company dedicated to the development, manufacture and marketing o...

Viwit Pharmaceuticals Limited (Viwit), founded in 2006, is a fast-growing research-based pharmaceutical healthcare company dedicated to the development, manufacture and marketing of innovative products in the fields of Finished Dosage Formulations, Active Pharmaceutical Ingredients and Fine Chemicals. Viwit manufactures all the products based on company’s core technologies, and is dedicated to serve customers for their greater success and healthier living.
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API Reference Price

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REDDY\\'S LABORATORIES","supplierCountry":"INDIA","foreign_port":"SHEREMETYEVO","customer":"GLOBE MEDICAL LLC","customerCountry":"RUSSIA","quantity":"0.04","actualQuantity":"0.036","unit":"KGS","unitRateFc":"9256.4","totalValueFC":"329.8","currency":"USD","unitRateINR":666925,"date":"06-Feb-2021","totalValueINR":"24009.3","totalValueInUsd":"329.8","indian_port":"HYDERABAD AIR","hs_no":"29420090","bill_no":"8455567","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"7-1-27, AMEERPET, HYDERABAD, ANDHRA PRADESH","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2021","qtr":"Q3","strtotime":1629657000,"product":"EFINACONAZOLE","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"CIPLA","supplierCountry":"INDIA","foreign_port":"SEOUL - INCHEON INT\\'","customer":"BL H CO, LTD,","customerCountry":"KOREA, REPUBLIC OF","quantity":"0.20","actualQuantity":"200","unit":"GMS","unitRateFc":"18","totalValueFC":"3505.8","currency":"USD","unitRateINR":1300.0989500000001,"date":"23-Aug-2021","totalValueINR":"260019.79","totalValueInUsd":"3505.8","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"4040505","productDescription":"API","marketType":"REGULATED MARKET","country":"KOREA,REPUBLIC OF","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"MUMBAI CENTRAL,, MUMBAI, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2021","qtr":"Q3","strtotime":1630953000,"product":"EFINACONAZOLE","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"CIPLA","supplierCountry":"INDIA","foreign_port":"SEOUL - INCHEON INT\\'","customer":"DONG WHA PHARM, CO, LTD,","customerCountry":"KOREA, REPUBLIC OF","quantity":"0.15","actualQuantity":"0.15","unit":"KGS","unitRateFc":"12000","totalValueFC":"1713","currency":"USD","unitRateINR":840000,"date":"07-Sep-2021","totalValueINR":"126000","totalValueInUsd":"1713","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"4427939","productDescription":"API","marketType":"REGULATED MARKET","country":"KOREA,REPUBLIC OF","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"MUMBAI CENTRAL,, MUMBAI, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2021","qtr":"Q3","strtotime":1632853800,"product":"EFINACONAZOLE","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"CIPLA","supplierCountry":"INDIA","foreign_port":"SEOUL - INCHEON INT\\'","customer":"BL & H CO. 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06-Feb-2021
31-Jul-2024
KGS
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