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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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CEP/COS

CEP/COS Certifications

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JDMF

JDMFs Filed

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EU WC

EU WC

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KDMF

KDMF

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NDC API

NDC API

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VMF

NDC API

API REF. PRICE (USD/KG)

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FDF

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Europe

Europe

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Australia

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2 RELATED EXCIPIENT COMPANIES

2EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: Dodecylheptaglycol, 3055-97-8, 3,6,9,12,15,18,21-heptaoxatritriacontan-1-ol, Laureth-7, Heptaethyleneglycolmonododecylether, 2-[2-[2-[2-[2-[2-(2-dodecoxyethoxy)ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethanol
Molecular Formula
C26H54O8
Molecular Weight
494.7  g/mol
InChI Key
DWHIUNMOTRUVPG-UHFFFAOYSA-N

Polidocanol
An alkyl polyglycol ether of LAURYL ALCOHOL, chemically defined as an alcohol ethoxylate having an average alkyl chain of 12??14 carbon atoms, and an ethylene oxide chain of 9 ethylene oxide units. It is used as a detergent, and medically as a local anesthetic, and as a sclerosing agent for the treatment of ESOPHAGEAL AND GASTRIC VARICES and VARICOSE VEINS.
1 2D Structure

Polidocanol

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-[2-[2-[2-[2-[2-(2-dodecoxyethoxy)ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethanol
2.1.2 InChI
InChI=1S/C26H54O8/c1-2-3-4-5-6-7-8-9-10-11-13-28-15-17-30-19-21-32-23-25-34-26-24-33-22-20-31-18-16-29-14-12-27/h27H,2-26H2,1H3
2.1.3 InChI Key
DWHIUNMOTRUVPG-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CCCCCCCCCCCCOCCOCCOCCOCCOCCOCCOCCO
2.2 Synonyms
2.2.1 MeSH Synonyms

1. Aethoxysclerol

2. Aethoxysklerol

3. Aetoxisclerol

4. Alpha-dodecyl-omega-hydroxypoly(oxy-1,2ethanediyl)

5. Atossisclerol

6. Atoxysclerol

7. Brij 30

8. Brij-30

9. Brij30

10. Dodecyl Ethyleneglycol Monoether

11. Dodecyl Ethyleneglycol Monoethers

12. Ether, Nonaethyleneglycol Monododecyl

13. Ether, Polyethylene Glycol-7-lauryl

14. Ether, Polyoxyethylene 9-lauryl

15. Ether, Polyoxyethylene Lauryl

16. Ether, Polyoxyethylene-4-dodecyl

17. Ether, Tetraethyleneglycol Lauryl

18. Ethoxysclerol

19. Ethyleneglycol Monoether, Dodecyl

20. Hydroxypolyethoxydodecane

21. Laureth

22. Laureth 1

23. Laureth 4

24. Laureth 7

25. Laureth 9

26. Laureth-1

27. Laureth-4

28. Laureth-7

29. Laureth-9

30. Laureths

31. Lauromacrogol

32. Lauromacrogol 400

33. Lauromacrogols

34. Lauryl Ether, Tetraethyleneglycol

35. Lubrol 12a9

36. Lubrol Px

37. Lubrol-px

38. Monododecyl Ether, Nonaethyleneglycol

39. Monoether, Dodecyl Ethyleneglycol

40. Nonaethylene Glycol Monododecyl Ether

41. Nonaethyleneglycol Monododecyl Ether

42. Nonaethyleneglycol Monododecyl Ethers

43. Polidocanol

44. Polidocanols

45. Polyethylene Glycol 7 Lauryl Ether

46. Polyethylene Glycol Monododecyl Ether

47. Polyethylene Glycol-7-lauryl Ether

48. Polyethylene Glycol-7-lauryl Ethers

49. Polyoxyethylene 4 Dodecyl Ether

50. Polyoxyethylene 9 Lauryl Ether

51. Polyoxyethylene 9-lauryl Ether

52. Polyoxyethylene 9-lauryl Ethers

53. Polyoxyethylene Lauryl Ether

54. Polyoxyethylene Lauryl Ethers

55. Polyoxyethylene(4) Lauryl Ether

56. Polyoxyethylene-4-dodecyl Ether

57. Polyoxyethylenedodecyl Ether

58. Polyoxyethylenedodecyl Ethers

59. Tetraethylene Glycol Dodecyl Ether

60. Tetraethyleneglycol Lauryl Ether

61. Tetraethyleneglycol Lauryl Ethers

62. Thesit

2.2.2 Depositor-Supplied Synonyms

1. Dodecylheptaglycol

2. 3055-97-8

3. 3,6,9,12,15,18,21-heptaoxatritriacontan-1-ol

4. Laureth-7

5. Heptaethyleneglycolmonododecylether

6. 2-[2-[2-[2-[2-[2-(2-dodecoxyethoxy)ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethanol

7. Polyoxyethylene (7) Lauryl Ether

8. C12e7

9. Einecs 221-283-9

10. Mfcd00043065

11. Polyethylene Glycol (7) Lauryl Ether

12. Peg-7 Lauryl Ether

13. Lauryl Alcohol Hexa(oxyethylene) Ethanol

14. Schembl60375

15. Dtxsid8062816

16. C12h25(oc2h4)7oh

17. Heptaethylene Glycol Dodecyl Ether

18. Akos025311016

19. Zinc100014200

20. Hy-w140896

21. Heptaethylene Glycol Mono-n-dodecyl Ether

22. As-78358

23. Cs-0199396

24. Ft-0726791

25. H0445

26. E78070

27. 055h978

28. J-018014

29. Heptaethylene Glycol Monododecyl Ether, Bioxtra, >=98.0% (tlc)

2.3 Create Date
2005-03-27
3 Chemical and Physical Properties
Molecular Weight 494.7 g/mol
Molecular Formula C26H54O8
XLogP34.2
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count8
Rotatable Bond Count31
Exact Mass494.38186868 g/mol
Monoisotopic Mass494.38186868 g/mol
Topological Polar Surface Area84.8 Ų
Heavy Atom Count34
Formal Charge0
Complexity347
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Pharmacology and Biochemistry
4.1 MeSH Pharmacological Classification

Detergents

Purifying or cleansing agents, usually salts of long-chain aliphatic bases or acids, that exert cleansing (oil-dissolving) and antimicrobial effects through a surface action that depends on possessing both hydrophilic and hydrophobic properties. (See all compounds classified as Detergents.)


Sclerosing Solutions

Chemical agents injected into blood vessels and lymphatic sinuses to shrink or cause localized THROMBOSIS; FIBROSIS, and obliteration of the vessels. This treatment is applied in a number of conditions such as VARICOSE VEINS; HEMORRHOIDS; GASTRIC VARICES; ESOPHAGEAL VARICES; PEPTIC ULCER HEMORRHAGE. (See all compounds classified as Sclerosing Solutions.)


API SUPPLIERS

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01

LGM Pharma

U.S.A

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

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AES 2024
Not Confirmed
  • fda
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  • WHO-GMP

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

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Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
LGM Pharma CB

02

Nanjing Well Pharmaceutical

China

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

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AES 2024
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

Flag China
Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Nanjing Well Pharmaceutical

03

Agno Pharma

U.S.A

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

AES 2024
Not Confirmed
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Agno Pharma

U.S.A

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

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AES 2024
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USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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USDMF

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Agno Pharma

U.S.A

USDMF

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AES 2024
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Agno Pharma

U.S.A
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AES 2024
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GDUFA

DMF Review : Complete

Rev. Date : 2024-11-08

Pay. Date : 2024-10-31

DMF Number : 37637

Submission : 2024-06-17

Status : Active

Type : II

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Listed Suppliers

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LGM Pharma

U.S.A
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  • WHO-GMP

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

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Digital Content Digital Content

Polidocanol

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

02

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AES 2024
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

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Digital Content Digital Content

Polidocanol

About the Company : Nanjing Well Pharmaceutical Group was established in 2000 & is committed to R&D & manufacture of pharmaceutical materials, base oils of advanced synthetic lubricants, etc. The grou...

Nanjing Well Pharmaceutical Group was established in 2000 & is committed to R&D & manufacture of pharmaceutical materials, base oils of advanced synthetic lubricants, etc. The group has 10 subsidiaries, which are distributed in Nanjing, Yangzhou, & other cities in China. Nanjing Well Pharmaceutical Technology is a wholly-owned subsidiary of the Group, & it is a new R&D & manufacturing center for pharmaceutical excipients & APIs. It is located in Nanjing Jiangbei New Material Science & Technology Park with 200+ employees & has 15 synthetic production lines which can achieve an annual output of >20,000 tons of pharmaceutical excipients & APIs.
Nanjing Well Pharmaceutical
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API Reference Price

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26-Nov-2023
26-Mar-2024
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Quantity (KGS) & Unit rate (USD/KGS) over time

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Drugs in Development

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Details:

10XB101 is a novel formulation of polidocanol which is approved in the U.S. for vein sclerotherapy. It is noe being evaluated for submental body contouring.


Lead Product(s): Polidocanol

Therapeutic Area: Nutrition and Weight Loss Brand Name: 10XB101

Study Phase: Phase IIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 11, 2024

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01

10xbio

U.S.A
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AES 2024
Not Confirmed

10xbio

U.S.A
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Not Confirmed

Details : 10XB101 is a novel formulation of polidocanol which is approved in the U.S. for vein sclerotherapy. It is noe being evaluated for submental body contouring.

Brand Name : 10XB101

Molecule Type : Small molecule

Upfront Cash : Not Applicable

March 11, 2024

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FDF Dossiers

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POLIDOCANOL

Brand Name : ASCLERA

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 10MG/2ML (5MG/ML)

Packaging :

Approval Date : 2010-03-30

Application Number : 21201

Regulatory Info : RX

Registration Country : USA

Moehs Chemische Fabrik Berg

02

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AES 2024
Not Confirmed

POLIDOCANOL

Brand Name : ASCLERA

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 20MG/2ML (10MG/ML)

Packaging :

Approval Date : 2010-03-30

Application Number : 21201

Regulatory Info : RX

Registration Country : USA

Moehs Chemische Fabrik Berg

03

AES 2024
Not Confirmed
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Salvia officinalis L.; Oils, Peppermint; Riboflavin; Nicotinamide; Menthyl alcohol; eucalyptol; Xylitol; Chlorhexidine; polidocanol; Glycerol

Brand Name :

Dosage Form : Oral/Liquid Spray

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Poland

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AES 2024
Not Confirmed
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Oils, Peppermint; Panthenolum; Riboflavin; Nicotinamide; Menthyl alcohol; eucalyptol; OCTENIDINE HYDROCHLORIDE; Xylitol; polidocanol; Glycerol

Brand Name :

Dosage Form : Oral/Liquid Spray

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Poland

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PROVENSIS

United Kingdom
AES 2024
Not Confirmed
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PROVENSIS

United Kingdom
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POLIDOCANOL

Brand Name : VARITHENA

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 180MG/18ML (10MG/ML)

Packaging :

Approval Date : 2013-11-25

Application Number : 205098

Regulatory Info : RX

Registration Country : USA

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06

PROVENSIS

United Kingdom
AES 2024
Not Confirmed
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PROVENSIS

United Kingdom
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POLIDOCANOL

Brand Name : VARITHENA

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 77.5MG/7.75ML (10MG/ML)

Packaging :

Approval Date : 2017-12-21

Application Number : 205098

Regulatory Info : DISCN

Registration Country : USA

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - SOLUTION;INTRAVENOUS - 180MG/18ML (1...DOSAGE - SOLUTION;INTRAVENOUS - 180MG/18ML (10MG/ML)

USFDA APPLICATION NUMBER - 205098

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DOSAGE - SOLUTION;INTRAVENOUS - 77.5MG/7.75ML...DOSAGE - SOLUTION;INTRAVENOUS - 77.5MG/7.75ML (10MG/ML)

USFDA APPLICATION NUMBER - 205098

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DOSAGE - SOLUTION;INTRAVENOUS - 10MG/2ML (5MG...DOSAGE - SOLUTION;INTRAVENOUS - 10MG/2ML (5MG/ML)

USFDA APPLICATION NUMBER - 21201

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DOSAGE - SOLUTION;INTRAVENOUS - 20MG/2ML (10M...DOSAGE - SOLUTION;INTRAVENOUS - 20MG/2ML (10MG/ML)

USFDA APPLICATION NUMBER - 21201

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