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API SUPPLIERS
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USDMF
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ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.
About the Company : ICE Pharma's core business includes the manufacture of active pharmaceutical ingredients, the most important of which is Ursodeoxycholic Acid (UDCA), used to treat liver diseases a...
Axplora- The partner of choice for complex APIs.
About the Company : Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-qual...
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REF. STANDARDS & IMPURITIES
ANALYTICAL
Analytical Methods
ABOUT THIS PAGE
A Chenodiol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Chenodiol, including repackagers and relabelers. The FDA regulates Chenodiol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Chenodiol 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 Chenodiol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Chenodiol supplier is an individual or a company that provides Chenodiol active pharmaceutical ingredient (API) or Chenodiol finished formulations upon request. The Chenodiol suppliers may include Chenodiol API manufacturers, exporters, distributors and traders.
click here to find a list of Chenodiol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Chenodiol DMF (Drug Master File) is a document detailing the whole manufacturing process of Chenodiol active pharmaceutical ingredient (API) in detail. Different forms of Chenodiol DMFs exist exist since differing nations have different regulations, such as Chenodiol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Chenodiol DMF submitted to regulatory agencies in the US is known as a USDMF. Chenodiol USDMF includes data on Chenodiol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Chenodiol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Chenodiol 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 Chenodiol Drug Master File in Korea (Chenodiol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Chenodiol. The MFDS reviews the Chenodiol KDMF as part of the drug registration process and uses the information provided in the Chenodiol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Chenodiol 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 Chenodiol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Chenodiol suppliers with KDMF on PharmaCompass.
A Chenodiol CEP of the European Pharmacopoeia monograph is often referred to as a Chenodiol Certificate of Suitability (COS). The purpose of a Chenodiol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Chenodiol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Chenodiol to their clients by showing that a Chenodiol CEP has been issued for it. The manufacturer submits a Chenodiol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Chenodiol CEP holder for the record. Additionally, the data presented in the Chenodiol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Chenodiol DMF.
A Chenodiol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Chenodiol 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 Chenodiol suppliers with CEP (COS) 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 Chenodiol as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Chenodiol 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 Chenodiol 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 Chenodiol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Chenodiol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Chenodiol suppliers with NDC on PharmaCompass.
Chenodiol 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 Chenodiol 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 Chenodiol GMP manufacturer or Chenodiol GMP API supplier for your needs.
A Chenodiol CoA (Certificate of Analysis) is a formal document that attests to Chenodiol's compliance with Chenodiol specifications and serves as a tool for batch-level quality control.
Chenodiol CoA mostly includes findings from lab analyses of a specific batch. For each Chenodiol 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.
Chenodiol may be tested according to a variety of international standards, such as European Pharmacopoeia (Chenodiol EP), Chenodiol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Chenodiol USP).
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