Synopsis
Synopsis
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CEP/COS
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JDMF
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EU WC
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KDMF
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NDC API
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VMF
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EDQM
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USP
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JP
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Others
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Europe
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Canada
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South Africa
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Listed Dossiers
DRUG PRODUCT COMPOSITIONS
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1. F6h8 Cpd
2. Perfluorhexyl-octan
3. Perfluorohexyl-octan
4. Perfluorohexyloctane
1. 133331-77-8
2. 1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluorotetradecane
3. Perfluorohexyloctane
4. 7vyx4elwqm
5. Perfluorohexyloctane [who-dd]
6. 1,1,1,2,2,3,3,4,4,5,5,6,6,-tridecafluorotetradecane
7. 1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluorotetradecane F 6h8
8. Tetradecane, 1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluoro-
9. Starbld0000620
10. Unii-7vyx4elwqm
11. 1-(tridecafluorohexyl)octane
12. Schembl890448
13. Dtxsid20440585
14. Mfcd07784188
15. Akos015911101
16. Zinc100046937
17. Bs-20913
18. Cs-0205555
19. A806597
20. J-006351
Molecular Weight | 432.26 g/mol |
---|---|
Molecular Formula | C14H17F13 |
XLogP3 | 8.7 |
Hydrogen Bond Donor Count | 0 |
Hydrogen Bond Acceptor Count | 13 |
Rotatable Bond Count | 11 |
Exact Mass | 432.1122666 g/mol |
Monoisotopic Mass | 432.1122666 g/mol |
Topological Polar Surface Area | 0 Ų |
Heavy Atom Count | 27 |
Formal Charge | 0 |
Complexity | 464 |
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 |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40173
Submission : 2024-07-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39428
Submission : 2024-04-30
Status : Active
Type : IV
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...
About the Company : Micro Labs Limited is a diversified healthcare company with cutting-edge R&D, advanced manufacturing facilities, and a strong distribution network. It ranks among India's top pharm...
Details:
MIEBO (perfluorohexyloctane ophthalmic solution) is used for the treatment of the signs and symptoms of dry eye disease (DED). MIEBO is the first and only prescription eye drop approved for DED that directly targets tear evaporation.
Lead Product(s): Perfluorohexyloctane
Therapeutic Area: Ophthalmology Brand Name: Miebo
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 12, 2023
Lead Product(s) : Perfluorohexyloctane
Therapeutic Area : Ophthalmology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Bausch + Lomb Launches MIEBO™ (Perfluorohexyloctane Ophthalmic Solution) in the United States
Details : MIEBO (perfluorohexyloctane ophthalmic solution) is used for the treatment of the signs and symptoms of dry eye disease (DED). MIEBO is the first and only prescription eye drop approved for DED that directly targets tear evaporation.
Product Name : Miebo
Product Type : Small molecule
Upfront Cash : Not Applicable
September 12, 2023
Details:
Under the agreement, Senju acquires Japan rights to develop, manufacture, and commercialize NOV03 (perfluorohexyloctane ophthalmic solution), the first and only prescription treatment for signs and symptoms of dry eye disease that directly targets tear evaporation.
Lead Product(s): Perfluorohexyloctane
Therapeutic Area: Ophthalmology Brand Name: NOV'03
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: SENJU PHARMACEUTICAL CO LTD
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement June 13, 2023
Lead Product(s) : Perfluorohexyloctane
Therapeutic Area : Ophthalmology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : SENJU PHARMACEUTICAL CO LTD
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Details : Under the agreement, Senju acquires Japan rights to develop, manufacture, and commercialize NOV03 (perfluorohexyloctane ophthalmic solution), the first and only prescription treatment for signs and symptoms of dry eye disease that directly targets tear e...
Product Name : NOV'03
Product Type : Small molecule
Upfront Cash : Undisclosed
June 13, 2023
Details:
Miebo (perfluorohexyloctane) is the first drug approved by USFDA to treat dry eye disease associated with Meibomian gland dysfunction. It stabilizes the lipid layer for hours to protect the tear film and has the ability to penetrate the Meibomian glands.
Lead Product(s): Perfluorohexyloctane
Therapeutic Area: Ophthalmology Brand Name: Miebo
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Novaliq
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 18, 2023
Lead Product(s) : Perfluorohexyloctane
Therapeutic Area : Ophthalmology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Novaliq
Deal Size : Not Applicable
Deal Type : Not Applicable
Bausch + Lomb and Novaliq Announce FDA Approval of MIEBO™ (Perfluorohexyloctane Ophthalmic Solut...
Details : Miebo (perfluorohexyloctane) is the first drug approved by USFDA to treat dry eye disease associated with Meibomian gland dysfunction. It stabilizes the lipid layer for hours to protect the tear film and has the ability to penetrate the Meibomian glands.
Product Name : Miebo
Product Type : Small molecule
Upfront Cash : Not Applicable
May 18, 2023
Details:
NOV03 (Perfluorohexyloctane) is the first drug developed to treat dry eye disease associated with Meibomian gland dysfunction in a highly effective way. It stabilizes the lipid layer for hours to protect the tear film and has the ability to penetrate the Meibomian glands.
Lead Product(s): Perfluorohexyloctane
Therapeutic Area: Ophthalmology Brand Name: 37926
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Novaliq
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 04, 2023
Lead Product(s) : Perfluorohexyloctane
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Novaliq
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : NOV03 (Perfluorohexyloctane) is the first drug developed to treat dry eye disease associated with Meibomian gland dysfunction in a highly effective way. It stabilizes the lipid layer for hours to protect the tear film and has the ability to penetrate the...
Product Name : 37926
Product Type : Small molecule
Upfront Cash : Not Applicable
January 04, 2023
Details:
NOV03 (perfluorohexyloctane) A potential first-in-class eye drop with a novel mechanism of action, NOV03 is an investigational therapy to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD).
Lead Product(s): Perfluorohexyloctane
Therapeutic Area: Ophthalmology Brand Name: 37926
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Novaliq
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 06, 2022
Lead Product(s) : Perfluorohexyloctane
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Novaliq
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : NOV03 (perfluorohexyloctane) A potential first-in-class eye drop with a novel mechanism of action, NOV03 is an investigational therapy to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD).
Product Name : 37926
Product Type : Small molecule
Upfront Cash : Not Applicable
September 06, 2022
Details:
NOV03 (perfluorohexyloctane) Ophthalmic Soluton, is an investigational, proprietary, water-free, single-component preservative-free eye drop , an investigational treatment with a proposed indication of treating the signs and symptoms of dry eye disease.
Lead Product(s): Perfluorohexyloctane
Therapeutic Area: Ophthalmology Brand Name: 37926
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Novaliq
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 07, 2022
Lead Product(s) : Perfluorohexyloctane
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Novaliq
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : NOV03 (perfluorohexyloctane) Ophthalmic Soluton, is an investigational, proprietary, water-free, single-component preservative-free eye drop , an investigational treatment with a proposed indication of treating the signs and symptoms of dry eye disease.
Product Name : 37926
Product Type : Small molecule
Upfront Cash : Not Applicable
July 07, 2022
Details:
NOV03 (perfluorohexyloctane) is being investigated as a first-in-class treatment with a novel mechanism of action to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD).
Lead Product(s): Perfluorohexyloctane
Therapeutic Area: Ophthalmology Brand Name: 37926
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 03, 2022
Lead Product(s) : Perfluorohexyloctane
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : NOV03 (perfluorohexyloctane) is being investigated as a first-in-class treatment with a novel mechanism of action to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD).
Product Name : 37926
Product Type : Small molecule
Upfront Cash : Not Applicable
May 03, 2022
Details:
Presentations include results from Phase 3 trials of investigational NOV03 (perfluorohexyloctane), as well as from several studies involving products from company's consumer health care, pharmaceutical and surgical portfolios, such as XIPERE for suprachoroidal use.
Lead Product(s): Perfluorohexyloctane
Therapeutic Area: Ophthalmology Brand Name: NOV03
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 28, 2022
Lead Product(s) : Perfluorohexyloctane
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Presentations include results from Phase 3 trials of investigational NOV03 (perfluorohexyloctane), as well as from several studies involving products from company's consumer health care, pharmaceutical and surgical portfolios, such as XIPERE for supracho...
Product Name : NOV03
Product Type : Small molecule
Upfront Cash : Not Applicable
April 28, 2022
Details:
The data show that NOV03, (perfluorohexyloctane) met both primary endpoints of total Corneal Fluorescein Staining, a measure that assesses damage to the eye, and visual analogue scale dryness score at day 57.
Lead Product(s): Perfluorohexyloctane
Therapeutic Area: Ophthalmology Brand Name: NOV03
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Bausch & Lomb Incorporated
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 25, 2022
Lead Product(s) : Perfluorohexyloctane
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Bausch & Lomb Incorporated
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : The data show that NOV03, (perfluorohexyloctane) met both primary endpoints of total Corneal Fluorescein Staining, a measure that assesses damage to the eye, and visual analogue scale dryness score at day 57.
Product Name : NOV03
Product Type : Small molecule
Upfront Cash : Not Applicable
April 25, 2022
Details:
Company provided update on phase 3 trial of SHR8058 eye drops (perfluorohexyloctane) for the treatment of dry eye disease associated with Meibomian gland dysfunction and the trial met its prespecified primary sign endpoint improvement of total corneal fluorescein staining.
Lead Product(s): Perfluorohexyloctane
Therapeutic Area: Ophthalmology Brand Name: SHR8058
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 16, 2021
Lead Product(s) : Perfluorohexyloctane
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Company provided update on phase 3 trial of SHR8058 eye drops (perfluorohexyloctane) for the treatment of dry eye disease associated with Meibomian gland dysfunction and the trial met its prespecified primary sign endpoint improvement of total corneal fl...
Product Name : SHR8058
Product Type : Small molecule
Upfront Cash : Not Applicable
December 16, 2021
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PharmaCompass offers a list of Perfluorohexyloctane 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 Perfluorohexyloctane manufacturer or Perfluorohexyloctane supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Perfluorohexyloctane manufacturer or Perfluorohexyloctane supplier.
PharmaCompass also assists you with knowing the Perfluorohexyloctane API Price utilized in the formulation of products. Perfluorohexyloctane API Price is not always fixed or binding as the Perfluorohexyloctane Price is obtained through a variety of data sources. The Perfluorohexyloctane Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Perfluorohexyloctane manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Perfluorohexyloctane, including repackagers and relabelers. The FDA regulates Perfluorohexyloctane manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Perfluorohexyloctane 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 Perfluorohexyloctane manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Perfluorohexyloctane supplier is an individual or a company that provides Perfluorohexyloctane active pharmaceutical ingredient (API) or Perfluorohexyloctane finished formulations upon request. The Perfluorohexyloctane suppliers may include Perfluorohexyloctane API manufacturers, exporters, distributors and traders.
click here to find a list of Perfluorohexyloctane suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Perfluorohexyloctane DMF (Drug Master File) is a document detailing the whole manufacturing process of Perfluorohexyloctane active pharmaceutical ingredient (API) in detail. Different forms of Perfluorohexyloctane DMFs exist exist since differing nations have different regulations, such as Perfluorohexyloctane USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Perfluorohexyloctane DMF submitted to regulatory agencies in the US is known as a USDMF. Perfluorohexyloctane USDMF includes data on Perfluorohexyloctane's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Perfluorohexyloctane USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Perfluorohexyloctane suppliers with USDMF on PharmaCompass.
Perfluorohexyloctane 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 Perfluorohexyloctane 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 Perfluorohexyloctane GMP manufacturer or Perfluorohexyloctane GMP API supplier for your needs.
A Perfluorohexyloctane CoA (Certificate of Analysis) is a formal document that attests to Perfluorohexyloctane's compliance with Perfluorohexyloctane specifications and serves as a tool for batch-level quality control.
Perfluorohexyloctane CoA mostly includes findings from lab analyses of a specific batch. For each Perfluorohexyloctane 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.
Perfluorohexyloctane may be tested according to a variety of international standards, such as European Pharmacopoeia (Perfluorohexyloctane EP), Perfluorohexyloctane JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Perfluorohexyloctane USP).