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API SUPPLIERS
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USDMF
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Drugs in Development
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Rochem International Inc
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Dacarbazine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dacarbazine, including repackagers and relabelers. The FDA regulates Dacarbazine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dacarbazine 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 Dacarbazine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dacarbazine supplier is an individual or a company that provides Dacarbazine active pharmaceutical ingredient (API) or Dacarbazine finished formulations upon request. The Dacarbazine suppliers may include Dacarbazine API manufacturers, exporters, distributors and traders.
click here to find a list of Dacarbazine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dacarbazine DMF (Drug Master File) is a document detailing the whole manufacturing process of Dacarbazine active pharmaceutical ingredient (API) in detail. Different forms of Dacarbazine DMFs exist exist since differing nations have different regulations, such as Dacarbazine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dacarbazine DMF submitted to regulatory agencies in the US is known as a USDMF. Dacarbazine USDMF includes data on Dacarbazine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dacarbazine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dacarbazine suppliers with USDMF on PharmaCompass.
A Dacarbazine CEP of the European Pharmacopoeia monograph is often referred to as a Dacarbazine Certificate of Suitability (COS). The purpose of a Dacarbazine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dacarbazine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dacarbazine to their clients by showing that a Dacarbazine CEP has been issued for it. The manufacturer submits a Dacarbazine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dacarbazine CEP holder for the record. Additionally, the data presented in the Dacarbazine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dacarbazine DMF.
A Dacarbazine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dacarbazine CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Dacarbazine suppliers with CEP (COS) on PharmaCompass.
A Dacarbazine written confirmation (Dacarbazine WC) is an official document issued by a regulatory agency to a Dacarbazine manufacturer, verifying that the manufacturing facility of a Dacarbazine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dacarbazine APIs or Dacarbazine finished pharmaceutical products to another nation, regulatory agencies frequently require a Dacarbazine WC (written confirmation) as part of the regulatory process.
click here to find a list of Dacarbazine 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 Dacarbazine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dacarbazine 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 Dacarbazine 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 Dacarbazine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dacarbazine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dacarbazine suppliers with NDC on PharmaCompass.
Dacarbazine 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 Dacarbazine 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 Dacarbazine GMP manufacturer or Dacarbazine GMP API supplier for your needs.
A Dacarbazine CoA (Certificate of Analysis) is a formal document that attests to Dacarbazine's compliance with Dacarbazine specifications and serves as a tool for batch-level quality control.
Dacarbazine CoA mostly includes findings from lab analyses of a specific batch. For each Dacarbazine 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.
Dacarbazine may be tested according to a variety of international standards, such as European Pharmacopoeia (Dacarbazine EP), Dacarbazine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dacarbazine USP).
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