Synopsis
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Molecular Weight | 1115.2 g/mol |
---|---|
Molecular Formula | C52H78N10O17 |
Hydrogen Bond Donor Count | 13 |
Hydrogen Bond Acceptor Count | 21 |
Rotatable Bond Count | 14 |
Exact Mass | 1114.55464106 g/mol |
Monoisotopic Mass | 1114.55464106 g/mol |
Topological Polar Surface Area | 399 A^2 |
Heavy Atom Count | 79 |
Formal Charge | 0 |
Complexity | 658 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 4 |
Undefined Atom Stereocenter Count | 3 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 7 |
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 : 5372
Submission : 1984-04-30
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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 : 6075
Submission : 1985-07-02
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Date of Issue : 2022-06-08
Valid Till : 2025-07-02
Written Confirmation Number : WC-0112nA2
Address of the Firm :
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6075
Submission : 1985-07-02
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5372
Submission : 1984-04-30
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Date of Issue : 2022-06-08
Valid Till : 2025-07-02
Written Confirmation Number : WC-0112nA2
Address of the Firm : Plot No. 69/A-2, GIDC Industrial Estate, Vapi, Dist-Valsad-396 175, Gujarat
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18 Mar 2021
ANALYTICAL
ABOUT THIS PAGE
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PharmaCompass offers a list of Methisoprinol 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 Methisoprinol manufacturer or Methisoprinol supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Methisoprinol manufacturer or Methisoprinol supplier.
PharmaCompass also assists you with knowing the Methisoprinol API Price utilized in the formulation of products. Methisoprinol API Price is not always fixed or binding as the Methisoprinol Price is obtained through a variety of data sources. The Methisoprinol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Metisoprinol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Metisoprinol, including repackagers and relabelers. The FDA regulates Metisoprinol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Metisoprinol API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Metisoprinol supplier is an individual or a company that provides Metisoprinol active pharmaceutical ingredient (API) or Metisoprinol finished formulations upon request. The Metisoprinol suppliers may include Metisoprinol API manufacturers, exporters, distributors and traders.
click here to find a list of Metisoprinol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Metisoprinol DMF (Drug Master File) is a document detailing the whole manufacturing process of Metisoprinol active pharmaceutical ingredient (API) in detail. Different forms of Metisoprinol DMFs exist exist since differing nations have different regulations, such as Metisoprinol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Metisoprinol DMF submitted to regulatory agencies in the US is known as a USDMF. Metisoprinol USDMF includes data on Metisoprinol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Metisoprinol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Metisoprinol suppliers with USDMF on PharmaCompass.
A Metisoprinol written confirmation (Metisoprinol WC) is an official document issued by a regulatory agency to a Metisoprinol manufacturer, verifying that the manufacturing facility of a Metisoprinol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Metisoprinol APIs or Metisoprinol finished pharmaceutical products to another nation, regulatory agencies frequently require a Metisoprinol WC (written confirmation) as part of the regulatory process.
click here to find a list of Metisoprinol suppliers with Written Confirmation (WC) on PharmaCompass.
Metisoprinol 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 Metisoprinol 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 Metisoprinol GMP manufacturer or Metisoprinol GMP API supplier for your needs.
A Metisoprinol CoA (Certificate of Analysis) is a formal document that attests to Metisoprinol's compliance with Metisoprinol specifications and serves as a tool for batch-level quality control.
Metisoprinol CoA mostly includes findings from lab analyses of a specific batch. For each Metisoprinol 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.
Metisoprinol may be tested according to a variety of international standards, such as European Pharmacopoeia (Metisoprinol EP), Metisoprinol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Metisoprinol USP).