Synopsis
Synopsis
0
USDMF
0
CEP/COS
0
EU WC
0
KDMF
0
NDC API
0
VMF
0
Listed Suppliers
0
API
0
FDF
0
FDF Dossiers
0
FDA Orange Book
0
Europe
0
Canada
0
Australia
0
South Africa
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS
0
EDQM
0
USP
0
JP
0
Others
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
US Medicaid
NA
Annual Reports
NA
Finished Drug Prices
NA
Molecular Weight | 385.5 g/mol |
---|---|
Molecular Formula | C23H31NO4 |
XLogP3 | 4.7 |
Hydrogen Bond Donor Count | 1 |
Hydrogen Bond Acceptor Count | 5 |
Rotatable Bond Count | 7 |
Exact Mass | 385.22530847 g/mol |
Monoisotopic Mass | 385.22530847 g/mol |
Topological Polar Surface Area | 72.5 A^2 |
Heavy Atom Count | 28 |
Formal Charge | 0 |
Complexity | 619 |
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 |
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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ABOUT THIS PAGE
A Falcon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Falcon, including repackagers and relabelers. The FDA regulates Falcon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Falcon 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 Falcon supplier is an individual or a company that provides Falcon active pharmaceutical ingredient (API) or Falcon finished formulations upon request. The Falcon suppliers may include Falcon API manufacturers, exporters, distributors and traders.
click here to find a list of Falcon suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Falcon Drug Master File in Japan (Falcon JDMF) empowers Falcon API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Falcon JDMF during the approval evaluation for pharmaceutical products. At the time of Falcon JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Falcon suppliers with JDMF on PharmaCompass.
Falcon 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 Falcon 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 Falcon GMP manufacturer or Falcon GMP API supplier for your needs.
A Falcon CoA (Certificate of Analysis) is a formal document that attests to Falcon's compliance with Falcon specifications and serves as a tool for batch-level quality control.
Falcon CoA mostly includes findings from lab analyses of a specific batch. For each Falcon 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.
Falcon may be tested according to a variety of international standards, such as European Pharmacopoeia (Falcon EP), Falcon JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Falcon USP).
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