Synopsis
0
CEP/COS
0
JDMF
0
KDMF
0
VMF
DRUG PRODUCT COMPOSITIONS0
EDQM
0
USP
0
JP
0
Others
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API Imports and Exports
Upgrade, download data, analyse, strategize, subscribe with us 
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - FOR SOLUTION;SUBCUTANEOUS - 20MG/VIA...DOSAGE - FOR SOLUTION;SUBCUTANEOUS - 20MG/VIAL
USFDA APPLICATION NUMBER - 20622
DOSAGE - INJECTABLE;SUBCUTANEOUS - 40MG/ML
USFDA APPLICATION NUMBER - 20622
Related Excipient Companies
Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pfanstiehl
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shijiazhuang Huaxu Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Chewable & Orodispersible Aids
Taste Masking
Direct Compression
Co-Processed Excipients
Parenteral
Granulation
Disintegrants & Superdisintegrants
Thickeners and Stabilizers
API Stability Enhancers
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
ABOUT THIS PAGE
A Copaxone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Copaxone, including repackagers and relabelers. The FDA regulates Copaxone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Copaxone 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 Copaxone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Copaxone supplier is an individual or a company that provides Copaxone active pharmaceutical ingredient (API) or Copaxone finished formulations upon request. The Copaxone suppliers may include Copaxone API manufacturers, exporters, distributors and traders.
click here to find a list of Copaxone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Copaxone DMF (Drug Master File) is a document detailing the whole manufacturing process of Copaxone active pharmaceutical ingredient (API) in detail. Different forms of Copaxone DMFs exist exist since differing nations have different regulations, such as Copaxone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Copaxone DMF submitted to regulatory agencies in the US is known as a USDMF. Copaxone USDMF includes data on Copaxone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Copaxone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Copaxone suppliers with USDMF on PharmaCompass.
A Copaxone written confirmation (Copaxone WC) is an official document issued by a regulatory agency to a Copaxone manufacturer, verifying that the manufacturing facility of a Copaxone active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Copaxone APIs or Copaxone finished pharmaceutical products to another nation, regulatory agencies frequently require a Copaxone WC (written confirmation) as part of the regulatory process.
click here to find a list of Copaxone suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Copaxone as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Copaxone API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Copaxone as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Copaxone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Copaxone NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Copaxone suppliers with NDC on PharmaCompass.
Copaxone 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 Copaxone 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 Copaxone GMP manufacturer or Copaxone GMP API supplier for your needs.
A Copaxone CoA (Certificate of Analysis) is a formal document that attests to Copaxone's compliance with Copaxone specifications and serves as a tool for batch-level quality control.
Copaxone CoA mostly includes findings from lab analyses of a specific batch. For each Copaxone 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.
Copaxone may be tested according to a variety of international standards, such as European Pharmacopoeia (Copaxone EP), Copaxone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Copaxone USP).
LOOKING FOR A SUPPLIER?
