API Suppliers
US DMFs Filed
CEP/COS Certifications
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Other Suppliers
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USA (Orange Book)
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Europe
Canada
Australia
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South Africa
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PharmaCompass offers a list of Carbon 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 Carbon manufacturer or Carbon supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Carbon manufacturer or Carbon supplier.
PharmaCompass also assists you with knowing the Carbon API Price utilized in the formulation of products. Carbon API Price is not always fixed or binding as the Carbon Price is obtained through a variety of data sources. The Carbon Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Carbon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Carbon, including repackagers and relabelers. The FDA regulates Carbon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Carbon 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 Carbon manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Carbon supplier is an individual or a company that provides Carbon active pharmaceutical ingredient (API) or Carbon finished formulations upon request. The Carbon suppliers may include Carbon API manufacturers, exporters, distributors and traders.
click here to find a list of Carbon suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Carbon DMF (Drug Master File) is a document detailing the whole manufacturing process of Carbon active pharmaceutical ingredient (API) in detail. Different forms of Carbon DMFs exist exist since differing nations have different regulations, such as Carbon USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Carbon DMF submitted to regulatory agencies in the US is known as a USDMF. Carbon USDMF includes data on Carbon's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Carbon USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Carbon 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 Carbon Drug Master File in Korea (Carbon KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Carbon. The MFDS reviews the Carbon KDMF as part of the drug registration process and uses the information provided in the Carbon KDMF to evaluate the safety and efficacy of the drug.
After submitting a Carbon 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 Carbon API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Carbon suppliers with KDMF on PharmaCompass.
A Carbon CEP of the European Pharmacopoeia monograph is often referred to as a Carbon Certificate of Suitability (COS). The purpose of a Carbon CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Carbon EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Carbon to their clients by showing that a Carbon CEP has been issued for it. The manufacturer submits a Carbon CEP (COS) as part of the market authorization procedure, and it takes on the role of a Carbon CEP holder for the record. Additionally, the data presented in the Carbon CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Carbon DMF.
A Carbon CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Carbon 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 Carbon suppliers with CEP (COS) on PharmaCompass.
Carbon 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 Carbon 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 Carbon GMP manufacturer or Carbon GMP API supplier for your needs.
A Carbon CoA (Certificate of Analysis) is a formal document that attests to Carbon's compliance with Carbon specifications and serves as a tool for batch-level quality control.
Carbon CoA mostly includes findings from lab analyses of a specific batch. For each Carbon 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.
Carbon may be tested according to a variety of international standards, such as European Pharmacopoeia (Carbon EP), Carbon JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Carbon USP).