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