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API SUPPLIERS
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USDMF
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Evonik
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Acamprosate Calcium 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 Acamprosate Calcium manufacturer or Acamprosate Calcium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Acamprosate Calcium manufacturer or Acamprosate Calcium supplier.
PharmaCompass also assists you with knowing the Acamprosate Calcium API Price utilized in the formulation of products. Acamprosate Calcium API Price is not always fixed or binding as the Acamprosate Calcium Price is obtained through a variety of data sources. The Acamprosate Calcium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Campral manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Campral, including repackagers and relabelers. The FDA regulates Campral manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Campral 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 Campral manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Campral supplier is an individual or a company that provides Campral active pharmaceutical ingredient (API) or Campral finished formulations upon request. The Campral suppliers may include Campral API manufacturers, exporters, distributors and traders.
click here to find a list of Campral suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Campral DMF (Drug Master File) is a document detailing the whole manufacturing process of Campral active pharmaceutical ingredient (API) in detail. Different forms of Campral DMFs exist exist since differing nations have different regulations, such as Campral USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Campral DMF submitted to regulatory agencies in the US is known as a USDMF. Campral USDMF includes data on Campral's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Campral USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Campral suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Campral Drug Master File in Korea (Campral KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Campral. The MFDS reviews the Campral KDMF as part of the drug registration process and uses the information provided in the Campral KDMF to evaluate the safety and efficacy of the drug.
After submitting a Campral KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Campral API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Campral suppliers with KDMF on PharmaCompass.
A Campral CEP of the European Pharmacopoeia monograph is often referred to as a Campral Certificate of Suitability (COS). The purpose of a Campral CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Campral EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Campral to their clients by showing that a Campral CEP has been issued for it. The manufacturer submits a Campral CEP (COS) as part of the market authorization procedure, and it takes on the role of a Campral CEP holder for the record. Additionally, the data presented in the Campral CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Campral DMF.
A Campral CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Campral 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 Campral suppliers with CEP (COS) on PharmaCompass.
A Campral written confirmation (Campral WC) is an official document issued by a regulatory agency to a Campral manufacturer, verifying that the manufacturing facility of a Campral active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Campral APIs or Campral finished pharmaceutical products to another nation, regulatory agencies frequently require a Campral WC (written confirmation) as part of the regulatory process.
click here to find a list of Campral 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 Campral as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Campral 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 Campral 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 Campral and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Campral NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Campral suppliers with NDC on PharmaCompass.
Campral 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 Campral 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 Campral GMP manufacturer or Campral GMP API supplier for your needs.
A Campral CoA (Certificate of Analysis) is a formal document that attests to Campral's compliance with Campral specifications and serves as a tool for batch-level quality control.
Campral CoA mostly includes findings from lab analyses of a specific batch. For each Campral 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.
Campral may be tested according to a variety of international standards, such as European Pharmacopoeia (Campral EP), Campral JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Campral USP).
