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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]Related Excipient Companies
Rochem International Inc
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
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REF. STANDARDS & IMPURITIES
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 Deticene manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Deticene, including repackagers and relabelers. The FDA regulates Deticene manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Deticene 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 Deticene manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Deticene supplier is an individual or a company that provides Deticene active pharmaceutical ingredient (API) or Deticene finished formulations upon request. The Deticene suppliers may include Deticene API manufacturers, exporters, distributors and traders.
click here to find a list of Deticene suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Deticene DMF (Drug Master File) is a document detailing the whole manufacturing process of Deticene active pharmaceutical ingredient (API) in detail. Different forms of Deticene DMFs exist exist since differing nations have different regulations, such as Deticene USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Deticene DMF submitted to regulatory agencies in the US is known as a USDMF. Deticene USDMF includes data on Deticene's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Deticene USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Deticene suppliers with USDMF on PharmaCompass.
A Deticene CEP of the European Pharmacopoeia monograph is often referred to as a Deticene Certificate of Suitability (COS). The purpose of a Deticene CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Deticene EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Deticene to their clients by showing that a Deticene CEP has been issued for it. The manufacturer submits a Deticene CEP (COS) as part of the market authorization procedure, and it takes on the role of a Deticene CEP holder for the record. Additionally, the data presented in the Deticene CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Deticene DMF.
A Deticene CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Deticene 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 Deticene suppliers with CEP (COS) on PharmaCompass.
A Deticene written confirmation (Deticene WC) is an official document issued by a regulatory agency to a Deticene manufacturer, verifying that the manufacturing facility of a Deticene active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Deticene APIs or Deticene finished pharmaceutical products to another nation, regulatory agencies frequently require a Deticene WC (written confirmation) as part of the regulatory process.
click here to find a list of Deticene 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 Deticene as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Deticene 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 Deticene 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 Deticene and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Deticene NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Deticene suppliers with NDC on PharmaCompass.
Deticene 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 Deticene 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 Deticene GMP manufacturer or Deticene GMP API supplier for your needs.
A Deticene CoA (Certificate of Analysis) is a formal document that attests to Deticene's compliance with Deticene specifications and serves as a tool for batch-level quality control.
Deticene CoA mostly includes findings from lab analyses of a specific batch. For each Deticene 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.
Deticene may be tested according to a variety of international standards, such as European Pharmacopoeia (Deticene EP), Deticene JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Deticene USP).
