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ABOUT THIS PAGE
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PharmaCompass offers a list of Chenodeoxycholic Acid 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 Chenodeoxycholic Acid manufacturer or Chenodeoxycholic Acid supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Chenodeoxycholic Acid manufacturer or Chenodeoxycholic Acid supplier.
PharmaCompass also assists you with knowing the Chenodeoxycholic Acid API Price utilized in the formulation of products. Chenodeoxycholic Acid API Price is not always fixed or binding as the Chenodeoxycholic Acid Price is obtained through a variety of data sources. The Chenodeoxycholic Acid Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 3a,7a-dihydroxy-5b-cholanic acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 3a,7a-dihydroxy-5b-cholanic acid, including repackagers and relabelers. The FDA regulates 3a,7a-dihydroxy-5b-cholanic acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 3a,7a-dihydroxy-5b-cholanic acid 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 3a,7a-dihydroxy-5b-cholanic acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 3a,7a-dihydroxy-5b-cholanic acid supplier is an individual or a company that provides 3a,7a-dihydroxy-5b-cholanic acid active pharmaceutical ingredient (API) or 3a,7a-dihydroxy-5b-cholanic acid finished formulations upon request. The 3a,7a-dihydroxy-5b-cholanic acid suppliers may include 3a,7a-dihydroxy-5b-cholanic acid API manufacturers, exporters, distributors and traders.
click here to find a list of 3a,7a-dihydroxy-5b-cholanic acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 3a,7a-dihydroxy-5b-cholanic acid DMF (Drug Master File) is a document detailing the whole manufacturing process of 3a,7a-dihydroxy-5b-cholanic acid active pharmaceutical ingredient (API) in detail. Different forms of 3a,7a-dihydroxy-5b-cholanic acid DMFs exist exist since differing nations have different regulations, such as 3a,7a-dihydroxy-5b-cholanic acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 3a,7a-dihydroxy-5b-cholanic acid DMF submitted to regulatory agencies in the US is known as a USDMF. 3a,7a-dihydroxy-5b-cholanic acid USDMF includes data on 3a,7a-dihydroxy-5b-cholanic acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 3a,7a-dihydroxy-5b-cholanic acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 3a,7a-dihydroxy-5b-cholanic acid 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 3a,7a-dihydroxy-5b-cholanic acid Drug Master File in Korea (3a,7a-dihydroxy-5b-cholanic acid KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 3a,7a-dihydroxy-5b-cholanic acid. The MFDS reviews the 3a,7a-dihydroxy-5b-cholanic acid KDMF as part of the drug registration process and uses the information provided in the 3a,7a-dihydroxy-5b-cholanic acid KDMF to evaluate the safety and efficacy of the drug.
After submitting a 3a,7a-dihydroxy-5b-cholanic acid 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 3a,7a-dihydroxy-5b-cholanic acid API can apply through the Korea Drug Master File (KDMF).
click here to find a list of 3a,7a-dihydroxy-5b-cholanic acid suppliers with KDMF on PharmaCompass.
A 3a,7a-dihydroxy-5b-cholanic acid CEP of the European Pharmacopoeia monograph is often referred to as a 3a,7a-dihydroxy-5b-cholanic acid Certificate of Suitability (COS). The purpose of a 3a,7a-dihydroxy-5b-cholanic acid CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 3a,7a-dihydroxy-5b-cholanic acid EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 3a,7a-dihydroxy-5b-cholanic acid to their clients by showing that a 3a,7a-dihydroxy-5b-cholanic acid CEP has been issued for it. The manufacturer submits a 3a,7a-dihydroxy-5b-cholanic acid CEP (COS) as part of the market authorization procedure, and it takes on the role of a 3a,7a-dihydroxy-5b-cholanic acid CEP holder for the record. Additionally, the data presented in the 3a,7a-dihydroxy-5b-cholanic acid CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 3a,7a-dihydroxy-5b-cholanic acid DMF.
A 3a,7a-dihydroxy-5b-cholanic acid CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 3a,7a-dihydroxy-5b-cholanic acid 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 3a,7a-dihydroxy-5b-cholanic acid 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 3a,7a-dihydroxy-5b-cholanic acid as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 3a,7a-dihydroxy-5b-cholanic acid 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 3a,7a-dihydroxy-5b-cholanic acid 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 3a,7a-dihydroxy-5b-cholanic acid and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 3a,7a-dihydroxy-5b-cholanic acid NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of 3a,7a-dihydroxy-5b-cholanic acid suppliers with NDC on PharmaCompass.
3a,7a-dihydroxy-5b-cholanic acid 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 3a,7a-dihydroxy-5b-cholanic acid 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 3a,7a-dihydroxy-5b-cholanic acid GMP manufacturer or 3a,7a-dihydroxy-5b-cholanic acid GMP API supplier for your needs.
A 3a,7a-dihydroxy-5b-cholanic acid CoA (Certificate of Analysis) is a formal document that attests to 3a,7a-dihydroxy-5b-cholanic acid's compliance with 3a,7a-dihydroxy-5b-cholanic acid specifications and serves as a tool for batch-level quality control.
3a,7a-dihydroxy-5b-cholanic acid CoA mostly includes findings from lab analyses of a specific batch. For each 3a,7a-dihydroxy-5b-cholanic acid 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.
3a,7a-dihydroxy-5b-cholanic acid may be tested according to a variety of international standards, such as European Pharmacopoeia (3a,7a-dihydroxy-5b-cholanic acid EP), 3a,7a-dihydroxy-5b-cholanic acid JP (Japanese Pharmacopeia) and the US Pharmacopoeia (3a,7a-dihydroxy-5b-cholanic acid USP).
