Synopsis
Synopsis
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CEP/COS
0
JDMF
0
EU WC
0
KDMF
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NDC API
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VMF
0
EDQM
0
USP
0
JP
0
Others
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FDA Orange Book
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Canada
0
Australia
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South Africa
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Listed Dossiers
DRUG PRODUCT COMPOSITIONS
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US Patents
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Stock Recap #PipelineProspector
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1. Baquacil
2. Cosmocil
3. Lavasept
4. Phmb Polymer
5. Polihexanide Hydrochloride
6. Poly(hexamethylene Biguanide)
7. Poly(hexamethylenebiguanide) Hydrochloride
8. Poly(iminocarbonimidoyliminocarbonimidoylimino-1,6-hexanediyl) Hydrochloride
9. Polyhexamethylen-biguanide
10. Polyhexamethylenbiguanid
11. Polyhexamethylenbiguanide
12. Polyhexamethylene Biguanide
13. Polyhexamethylene Biguanide Hydrochloride
14. Polyhexanide
15. Vantocil
16. Vantocil Ib Of Vantocil
1. Polyhexamethylene Biguanide
2. 28757-47-3
3. Polyhexanide
4. 1-(diaminomethylidene)-2-hexylguanidine
5. Lavasept
6. Vantocil
7. Polihexanide Hydrochloride
8. Purista
9. Microcare Mbg
10. Cosmocil Cq
11. N-hexylbiguanide
12. 1-hexylbiguanide
13. Schembl45011
14. Chembl2106939
15. Schembl20753163
16. Dtxsid40873856
17. N-hexylimidodicarbonimidic Diamide
18. Zinc4217340
19. Akos017531707
20. Ft-0700841
21. Q408205
22. 24717-31-5
| Molecular Weight | 185.27 g/mol |
|---|---|
| Molecular Formula | C8H19N5 |
| XLogP3 | 0.5 |
| Hydrogen Bond Donor Count | 3 |
| Hydrogen Bond Acceptor Count | 1 |
| Rotatable Bond Count | 6 |
| Exact Mass | 185.16404563 g/mol |
| Monoisotopic Mass | 185.16404563 g/mol |
| Topological Polar Surface Area | 103 Ų |
| Heavy Atom Count | 13 |
| Formal Charge | 0 |
| Complexity | 181 |
| 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 |
Treatment of Acanthamoeba keratitis
Disinfectants
Substances used on inanimate objects that destroy harmful microorganisms or inhibit their activity. Disinfectants are classed as complete, destroying SPORES as well as vegetative forms of microorganisms, or incomplete, destroying only vegetative forms of the organisms. They are distinguished from ANTISEPTICS, which are local anti-infective agents used on humans and other animals. (From Hawley's Condensed Chemical Dictionary, 11th ed) (See all compounds classified as Disinfectants.)
D - Dermatologicals
D08 - Antiseptics and disinfectants
D08A - Antiseptics and disinfectants
D08AC - Biguanides and amidines
D08AC05 - Polihexanide
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38861
Submission : 2023-10-27
Status : Active
Type : II

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
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Corporate PDF




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Details:
The Group will invest into the further development of Akantior (polihexanide) into existing and new geographies, as well as the development of polihexanide into additional orphan indications.
Lead Product(s): Polyhexanide,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: Akantior
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Faes Farma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Merger June 10, 2025

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Lead Product(s) : Polyhexanide,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Faes Farma
Deal Size : Undisclosed
Deal Type : Merger
SIFI Merges into Faes Farma to Expand International Access to its Portfolio and Pipeline
Details : The Group will invest into the further development of Akantior (polihexanide) into existing and new geographies, as well as the development of polihexanide into additional orphan indications.
Product Name : Akantior
Product Type : Miscellaneous
Upfront Cash : Undisclosed
June 10, 2025

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The collaboration aims to evaluate the Akantior (polihexanide), the first and only approved drug for the treatment of AK. It is being indicated for the treatment of Acanthamoeba Keratitis in US.
Lead Product(s): Polyhexanide,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: Akantior
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: University of California
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration March 18, 2025

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Lead Product(s) : Polyhexanide,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : University of California
Deal Size : Undisclosed
Deal Type : Collaboration
SIFI, UCSF Collaborate on Acanthamoeba Keratitis Research
Details : The collaboration aims to evaluate the Akantior (polihexanide), the first and only approved drug for the treatment of AK. It is being indicated for the treatment of Acanthamoeba Keratitis in US.
Product Name : Akantior
Product Type : Miscellaneous
Upfront Cash : Undisclosed
March 18, 2025

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Details:
The agreement aims for the distribution of revyve, an antimicrobial wound gel product line in infection management and wound healing.
Lead Product(s): Polyhexanide,Citric Acid,Edetate Calcium Disodium
Therapeutic Area: Podiatry Brand Name: Revyve
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Best Buy Medical Canada
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement March 11, 2025

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Lead Product(s) : Polyhexanide,Citric Acid,Edetate Calcium Disodium
Therapeutic Area : Podiatry
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Best Buy Medical Canada
Deal Size : Undisclosed
Deal Type : Agreement
Kane Announces Canadian Distribution Agreement with Best Buy Medical for Revyve
Details : The agreement aims for the distribution of revyve, an antimicrobial wound gel product line in infection management and wound healing.
Product Name : Revyve
Product Type : Miscellaneous
Upfront Cash : Undisclosed
March 11, 2025

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Details:
Akantior (polihexanide) is an investigational anti-amoebic polymer that got approval from european medicines agency for the treament of acanthamoeba keratitis.
Lead Product(s): Polyhexanide,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: Akantior
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 16, 2024

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Lead Product(s) : Polyhexanide,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
SIFI Updates AKANTIOR® Regulatory Pathway for Acanthamoeba Keratitis in UK and US
Details : Akantior (polihexanide) is an investigational anti-amoebic polymer that got approval from european medicines agency for the treament of acanthamoeba keratitis.
Product Name : Akantior
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 16, 2024

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Details:
BioStem Technologies will acquire exclusive US distribution rights for revyve from ProgenaCare Global.
Lead Product(s): Polyhexanide,Citric Acid,Edetate Calcium Disodium
Therapeutic Area: Podiatry Brand Name: Revyve
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: BioStem Technologies
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership November 27, 2024

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Lead Product(s) : Polyhexanide,Citric Acid,Edetate Calcium Disodium
Therapeutic Area : Podiatry
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : BioStem Technologies
Deal Size : Undisclosed
Deal Type : Partnership
Kane Biotech Changes US Partner for Revyve™ Antimicrobial Wound Gel Distribution
Details : BioStem Technologies will acquire exclusive US distribution rights for revyve from ProgenaCare Global.
Product Name : Revyve
Product Type : Miscellaneous
Upfront Cash : Undisclosed
November 27, 2024

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Details:
Revyve Antimicrobial Wound Gel is indicated for management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), burns, partial & full thickness wounds for adult populations.
Lead Product(s): Polyhexanide,Citric Acid,Edetate Calcium Disodium
Therapeutic Area: Trauma (Emergency, Injury, Surgery) Brand Name: Revyve
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 14, 2024

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Lead Product(s) : Polyhexanide,Citric Acid,Edetate Calcium Disodium
Therapeutic Area : Trauma (Emergency, Injury, Surgery)
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Kane Biotech Announces Health Canada Approval of revyve™ Antimicrobial Wound Gel
Details : Revyve Antimicrobial Wound Gel is indicated for management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), burns, partial & full thickness wounds for adult populations.
Product Name : Revyve
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 14, 2024

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Details:
The agreement aims for the distribution of revyve antimicrobial wound gel indicated for diabetic foot ulcers, in the Qatar wound care market.
Lead Product(s): Polyhexanide,Citric Acid,Edetate Calcium Disodium
Therapeutic Area: Podiatry Brand Name: Revyve
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Qatar Datamation Systems
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement August 28, 2024

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Lead Product(s) : Polyhexanide,Citric Acid,Edetate Calcium Disodium
Therapeutic Area : Podiatry
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Qatar Datamation Systems
Deal Size : Undisclosed
Deal Type : Agreement
Kane Biotech Signs Deal with Qatar Datamation For Wound Gel Distribution
Details : The agreement aims for the distribution of revyve antimicrobial wound gel indicated for diabetic foot ulcers, in the Qatar wound care market.
Product Name : Revyve
Product Type : Miscellaneous
Upfront Cash : Undisclosed
August 28, 2024

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Details:
Akantior (polihexanide) is an investigational anti-amoebic polymer that got approval from european medicines agency for the treament of acanthamoeba keratitis.
Lead Product(s): Polyhexanide,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: Akantior
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 26, 2024

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Lead Product(s) : Polyhexanide,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
SIFI Receives European Commission Approval for AKANTIOR®
Details : Akantior (polihexanide) is an investigational anti-amoebic polymer that got approval from european medicines agency for the treament of acanthamoeba keratitis.
Product Name : Akantior
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 26, 2024

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Details:
Akantior (polihexanide) is an investigational anti-amoebic polymer that recieved positive opinion from European Medicines Agency for the treament of acanthamoeba keratitis.
Lead Product(s): Polyhexanide,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: Akantior
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 22, 2024

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Lead Product(s) : Polyhexanide,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
SIFI Receives Positive Opinion for Orphan Drug Designation for Polihexanide
Details : Akantior (polihexanide) is an investigational anti-amoebic polymer that recieved positive opinion from European Medicines Agency for the treament of acanthamoeba keratitis.
Product Name : Akantior
Product Type : Miscellaneous
Upfront Cash : Inapplicable
July 22, 2024

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Details:
Akantior (polihexanide) is an investigational anti-amoebic polymer that recieved positive opinion from European Medicines Agency for the treament of acanthamoeba keratitis.
Lead Product(s): Polyhexanide,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: Akantior
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 03, 2024

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Lead Product(s) : Polyhexanide,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Avanzanite’s AKANTIOR® Gets Positive CHMP Opinion and Expands into 26 European Countries
Details : Akantior (polihexanide) is an investigational anti-amoebic polymer that recieved positive opinion from European Medicines Agency for the treament of acanthamoeba keratitis.
Product Name : Akantior
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 03, 2024

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Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Lavasept
Dosage Form : Concentrate
Dosage Strength : 200mg/ml
Packaging :
Approval Date : 17/12/1991
Application Number : 50445
Regulatory Info : Allowed
Registration Country : Switzerland

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Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Lavasept
Dosage Form : Solvent
Dosage Strength : 0.4mg/ml
Packaging :
Approval Date : 17/12/1991
Application Number : 50445
Regulatory Info : Allowed
Registration Country : Switzerland

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Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Acanthior
Dosage Form : Eye Drop
Dosage Strength : 0.8mg/ml
Packaging :
Approval Date : 23/08/2024
Application Number : 20220503000015
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Akantior
Dosage Form : Eye Drop In Solution In Single-Dose Container
Dosage Strength : 0.8MG
Packaging :
Approval Date : 2024-11-12
Application Number : 1241840002
Regulatory Info : Authorized
Registration Country : Spain

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ABOUT THIS PAGE
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PharmaCompass offers a list of Polyhexanide API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Polyhexanide manufacturer or Polyhexanide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Polyhexanide manufacturer or Polyhexanide supplier.
PharmaCompass also assists you with knowing the Polyhexanide API Price utilized in the formulation of products. Polyhexanide API Price is not always fixed or binding as the Polyhexanide Price is obtained through a variety of data sources. The Polyhexanide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Polyhexanide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Polyhexanide, including repackagers and relabelers. The FDA regulates Polyhexanide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Polyhexanide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Polyhexanide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Polyhexanide supplier is an individual or a company that provides Polyhexanide active pharmaceutical ingredient (API) or Polyhexanide finished formulations upon request. The Polyhexanide suppliers may include Polyhexanide API manufacturers, exporters, distributors and traders.
click here to find a list of Polyhexanide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Polyhexanide DMF (Drug Master File) is a document detailing the whole manufacturing process of Polyhexanide active pharmaceutical ingredient (API) in detail. Different forms of Polyhexanide DMFs exist exist since differing nations have different regulations, such as Polyhexanide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Polyhexanide DMF submitted to regulatory agencies in the US is known as a USDMF. Polyhexanide USDMF includes data on Polyhexanide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Polyhexanide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Polyhexanide suppliers with USDMF on PharmaCompass.
Polyhexanide Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Polyhexanide GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Polyhexanide GMP manufacturer or Polyhexanide GMP API supplier for your needs.
A Polyhexanide CoA (Certificate of Analysis) is a formal document that attests to Polyhexanide's compliance with Polyhexanide specifications and serves as a tool for batch-level quality control.
Polyhexanide CoA mostly includes findings from lab analyses of a specific batch. For each Polyhexanide CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Polyhexanide may be tested according to a variety of international standards, such as European Pharmacopoeia (Polyhexanide EP), Polyhexanide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Polyhexanide USP).