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API SUPPLIERS
ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.
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KDMF
Axplora- The partner of choice for complex APIs.
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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USDMF
ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31188
Submission : 2016-11-21
Status :
Type : II
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2001
Submission : 1972-09-29
Status :
Type : II
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ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.
Chenodeoxycholic acid and ursodeoxycholic acid magnesium trihydrate
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2021-03-18
Registration Number : 20210318-211-J-892
Manufacturer Name : ICE SpA@ ICE SPA@Raichem Med...
Manufacturer Address : Via Sicilia, 8-10 42122 Reggio Emilia ITALY @Via Novi 78, 15060 Basaluzzo(AL), Italy@...
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03 Mar 2022
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10 Aug 2021
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REF. STANDARDS & IMPURITIES
ANALYTICAL
Analytical Methods
ABOUT THIS PAGE
A Chenodeoxycholic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Chenodeoxycholic Acid, including repackagers and relabelers. The FDA regulates Chenodeoxycholic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Chenodeoxycholic 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 Chenodeoxycholic Acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Chenodeoxycholic Acid supplier is an individual or a company that provides Chenodeoxycholic Acid active pharmaceutical ingredient (API) or Chenodeoxycholic Acid finished formulations upon request. The Chenodeoxycholic Acid suppliers may include Chenodeoxycholic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Chenodeoxycholic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Chenodeoxycholic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Chenodeoxycholic Acid active pharmaceutical ingredient (API) in detail. Different forms of Chenodeoxycholic Acid DMFs exist exist since differing nations have different regulations, such as Chenodeoxycholic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Chenodeoxycholic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Chenodeoxycholic Acid USDMF includes data on Chenodeoxycholic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Chenodeoxycholic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Chenodeoxycholic 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 Chenodeoxycholic Acid Drug Master File in Korea (Chenodeoxycholic Acid KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Chenodeoxycholic Acid. The MFDS reviews the Chenodeoxycholic Acid KDMF as part of the drug registration process and uses the information provided in the Chenodeoxycholic Acid KDMF to evaluate the safety and efficacy of the drug.
After submitting a Chenodeoxycholic 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 Chenodeoxycholic Acid API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Chenodeoxycholic Acid suppliers with KDMF on PharmaCompass.
A Chenodeoxycholic Acid CEP of the European Pharmacopoeia monograph is often referred to as a Chenodeoxycholic Acid Certificate of Suitability (COS). The purpose of a Chenodeoxycholic Acid CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Chenodeoxycholic Acid EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Chenodeoxycholic Acid to their clients by showing that a Chenodeoxycholic Acid CEP has been issued for it. The manufacturer submits a Chenodeoxycholic Acid CEP (COS) as part of the market authorization procedure, and it takes on the role of a Chenodeoxycholic Acid CEP holder for the record. Additionally, the data presented in the Chenodeoxycholic Acid CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Chenodeoxycholic Acid DMF.
A Chenodeoxycholic Acid CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Chenodeoxycholic 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 Chenodeoxycholic 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 Chenodeoxycholic Acid as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Chenodeoxycholic 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 Chenodeoxycholic 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 Chenodeoxycholic Acid and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Chenodeoxycholic Acid NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Chenodeoxycholic Acid suppliers with NDC on PharmaCompass.
Chenodeoxycholic 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 Chenodeoxycholic 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 Chenodeoxycholic Acid GMP manufacturer or Chenodeoxycholic Acid GMP API supplier for your needs.
A Chenodeoxycholic Acid CoA (Certificate of Analysis) is a formal document that attests to Chenodeoxycholic Acid's compliance with Chenodeoxycholic Acid specifications and serves as a tool for batch-level quality control.
Chenodeoxycholic Acid CoA mostly includes findings from lab analyses of a specific batch. For each Chenodeoxycholic 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.
Chenodeoxycholic Acid may be tested according to a variety of international standards, such as European Pharmacopoeia (Chenodeoxycholic Acid EP), Chenodeoxycholic Acid JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Chenodeoxycholic Acid USP).
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