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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.
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A MolPort-023-220-188 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of MolPort-023-220-188, including repackagers and relabelers. The FDA regulates MolPort-023-220-188 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. MolPort-023-220-188 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A MolPort-023-220-188 DMF (Drug Master File) is a document detailing the whole manufacturing process of MolPort-023-220-188 active pharmaceutical ingredient (API) in detail. Different forms of MolPort-023-220-188 DMFs exist exist since differing nations have different regulations, such as MolPort-023-220-188 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A MolPort-023-220-188 DMF submitted to regulatory agencies in the US is known as a USDMF. MolPort-023-220-188 USDMF includes data on MolPort-023-220-188's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The MolPort-023-220-188 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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A MolPort-023-220-188 written confirmation (MolPort-023-220-188 WC) is an official document issued by a regulatory agency to a MolPort-023-220-188 manufacturer, verifying that the manufacturing facility of a MolPort-023-220-188 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting MolPort-023-220-188 APIs or MolPort-023-220-188 finished pharmaceutical products to another nation, regulatory agencies frequently require a MolPort-023-220-188 WC (written confirmation) as part of the regulatory process.
click here to find a list of MolPort-023-220-188 suppliers with Written Confirmation (WC) on PharmaCompass.
MolPort-023-220-188 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 MolPort-023-220-188 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 MolPort-023-220-188 GMP manufacturer or MolPort-023-220-188 GMP API supplier for your needs.
A MolPort-023-220-188 CoA (Certificate of Analysis) is a formal document that attests to MolPort-023-220-188's compliance with MolPort-023-220-188 specifications and serves as a tool for batch-level quality control.
MolPort-023-220-188 CoA mostly includes findings from lab analyses of a specific batch. For each MolPort-023-220-188 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.
MolPort-023-220-188 may be tested according to a variety of international standards, such as European Pharmacopoeia (MolPort-023-220-188 EP), MolPort-023-220-188 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (MolPort-023-220-188 USP).