Synopsis
Synopsis
0
CEP/COS
0
JDMF
0
EU WC
0
KDMF
0
NDC API
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VMF
0
FDF
0
FDF Dossiers
0
FDA Orange Book
0
Europe
0
Canada
0
Australia
0
South Africa
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS
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EDQM
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USP
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JP
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Others
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US Patents
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US Exclusivities
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Health Canada Patents
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
US Medicaid
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Annual Reports
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Finished Drug Prices
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1. Super Squalene; Trans-squalene;addavax
2. 7683-64-9
3. Squalen
4. Chembl3561564
5. Dtxsid4064767
6. Akos025243731
7. Ncgc00181323-02
8. Ft-0772415
Molecular Weight | 410.7 g/mol |
---|---|
Molecular Formula | C30H50 |
XLogP3 | 11.6 |
Hydrogen Bond Donor Count | 0 |
Hydrogen Bond Acceptor Count | 0 |
Rotatable Bond Count | 15 |
Exact Mass | 410.391251595 g/mol |
Monoisotopic Mass | 410.391251595 g/mol |
Topological Polar Surface Area | 0 Ų |
Heavy Atom Count | 30 |
Formal Charge | 0 |
Complexity | 578 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 4 |
Covalently Bonded Unit Count | 1 |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38189
Submission : 2023-03-28
Status : Active
Type : IV
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 : 2988
Submission : 1977-07-25
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12515
Submission : 1997-05-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38189
Submission : 2023-03-28
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12515
Submission : 1997-05-23
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2988
Submission : 1977-07-25
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Details:
Under the terms of the agreement, CSL Seqirus will deliver an H5N8 A/Astrakhan virus vaccine candidate and will then sponsor a subsequent Phase 2 clinical trial to evaluate the candidate along with CSL Seqirus' proprietary adjuvant MF59®.
Lead Product(s): H5N8 A/Astrakhan Virus Vaccine,Squalene API
Therapeutic Area: Infections and Infectious Diseases Brand Name: H5N8 A/Astrakhan
Study Phase: PreclinicalProduct Type: Vaccine
Sponsor: BARDA
Deal Size: $30.1 million Upfront Cash: Undisclosed
Deal Type: Agreement October 06, 2022
Lead Product(s) : H5N8 A/Astrakhan Virus Vaccine,Squalene API
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : BARDA
Deal Size : $30.1 million
Deal Type : Agreement
Details : Under the terms of the agreement, CSL Seqirus will deliver an H5N8 A/Astrakhan virus vaccine candidate and will then sponsor a subsequent Phase 2 clinical trial to evaluate the candidate along with CSL Seqirus' proprietary adjuvant MF59®.
Brand Name : H5N8 A/Astrakhan
Molecule Type : Vaccine
Upfront Cash : Undisclosed
October 06, 2022
Details:
CSL said it will provide technical expertise and a donation of MF59 to the University of Queensland’s preclinical development program.
Lead Product(s): Squalene API
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: PreclinicalProduct Type: Small molecule
Sponsor: University of Queensland
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration February 12, 2020
Lead Product(s) : Squalene API
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : University of Queensland
Deal Size : Undisclosed
Deal Type : Collaboration
CSL Collaborates With University of Queensland for Treatment of COVID-19
Details : CSL said it will provide technical expertise and a donation of MF59 to the University of Queensland’s preclinical development program.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Undisclosed
February 12, 2020
Related Excipient Companies
Dosage Form : Injectable / Parenteral
Grade : Parenteral
Application : Parenteral
Excipient Details : Castor oil is used as an oily solvent in parenteral dosage forms.
Market Place
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16 Sep 2024
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11 Mar 2019
ABOUT THIS PAGE
A Squalene API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Squalene API, including repackagers and relabelers. The FDA regulates Squalene API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Squalene API 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 Squalene API manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Squalene API supplier is an individual or a company that provides Squalene API active pharmaceutical ingredient (API) or Squalene API finished formulations upon request. The Squalene API suppliers may include Squalene API API manufacturers, exporters, distributors and traders.
click here to find a list of Squalene API suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Squalene API DMF (Drug Master File) is a document detailing the whole manufacturing process of Squalene API active pharmaceutical ingredient (API) in detail. Different forms of Squalene API DMFs exist exist since differing nations have different regulations, such as Squalene API USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Squalene API DMF submitted to regulatory agencies in the US is known as a USDMF. Squalene API USDMF includes data on Squalene API's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Squalene API USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Squalene API suppliers with USDMF on PharmaCompass.
Squalene API 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 Squalene API 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 Squalene API GMP manufacturer or Squalene API GMP API supplier for your needs.
A Squalene API CoA (Certificate of Analysis) is a formal document that attests to Squalene API's compliance with Squalene API specifications and serves as a tool for batch-level quality control.
Squalene API CoA mostly includes findings from lab analyses of a specific batch. For each Squalene API 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.
Squalene API may be tested according to a variety of international standards, such as European Pharmacopoeia (Squalene API EP), Squalene API JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Squalene API USP).
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