Synopsis
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USP
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API SUPPLIERS
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USDMF
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
Lead Product(s) : Alemtuzumab, Glatiramer Acetate, Methylprednisolone, Ranitidine, Cetirizine
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Alemtuzumab is a Antibody drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Multiple Sclerosis.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
December 11, 2017
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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
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ABOUT THIS PAGE
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PharmaCompass offers a list of Glatiramer Acetate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Glatiramer Acetate manufacturer or Glatiramer Acetate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Glatiramer Acetate manufacturer or Glatiramer Acetate supplier.
A Glatiramer Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Glatiramer Acetate, including repackagers and relabelers. The FDA regulates Glatiramer Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Glatiramer Acetate 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 Glatiramer Acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Glatiramer Acetate supplier is an individual or a company that provides Glatiramer Acetate active pharmaceutical ingredient (API) or Glatiramer Acetate finished formulations upon request. The Glatiramer Acetate suppliers may include Glatiramer Acetate API manufacturers, exporters, distributors and traders.
click here to find a list of Glatiramer Acetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Glatiramer Acetate DMF (Drug Master File) is a document detailing the whole manufacturing process of Glatiramer Acetate active pharmaceutical ingredient (API) in detail. Different forms of Glatiramer Acetate DMFs exist exist since differing nations have different regulations, such as Glatiramer Acetate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Glatiramer Acetate DMF submitted to regulatory agencies in the US is known as a USDMF. Glatiramer Acetate USDMF includes data on Glatiramer Acetate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Glatiramer Acetate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Glatiramer Acetate suppliers with USDMF on PharmaCompass.
A Glatiramer Acetate written confirmation (Glatiramer Acetate WC) is an official document issued by a regulatory agency to a Glatiramer Acetate manufacturer, verifying that the manufacturing facility of a Glatiramer Acetate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Glatiramer Acetate APIs or Glatiramer Acetate finished pharmaceutical products to another nation, regulatory agencies frequently require a Glatiramer Acetate WC (written confirmation) as part of the regulatory process.
click here to find a list of Glatiramer Acetate 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 Glatiramer Acetate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Glatiramer Acetate 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 Glatiramer Acetate 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 Glatiramer Acetate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Glatiramer Acetate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Glatiramer Acetate suppliers with NDC on PharmaCompass.
Glatiramer Acetate 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 Glatiramer Acetate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Glatiramer Acetate GMP manufacturer or Glatiramer Acetate GMP API supplier for your needs.
A Glatiramer Acetate CoA (Certificate of Analysis) is a formal document that attests to Glatiramer Acetate's compliance with Glatiramer Acetate specifications and serves as a tool for batch-level quality control.
Glatiramer Acetate CoA mostly includes findings from lab analyses of a specific batch. For each Glatiramer Acetate 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.
Glatiramer Acetate may be tested according to a variety of international standards, such as European Pharmacopoeia (Glatiramer Acetate EP), Glatiramer Acetate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Glatiramer Acetate USP).
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