Synopsis
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0
JDMF
0
VMF
0
FDF
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Europe
0
Canada
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Australia
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South Africa
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : Complete
Rev. Date : 2015-03-30
Pay. Date : 2014-10-09
DMF Number : 24540
Submission : 2011-01-07
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23540
Submission : 2010-02-19
Status :
Type : II
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DRUG PRODUCT COMPOSITIONS
DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 1...DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 135MG FENOFIBRIC ACID
USFDA APPLICATION NUMBER - 22224
DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 4...DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 45MG FENOFIBRIC ACID
USFDA APPLICATION NUMBER - 22224
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Choline Fenofibrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Choline Fenofibrate, including repackagers and relabelers. The FDA regulates Choline Fenofibrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Choline Fenofibrate 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 Choline Fenofibrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Choline Fenofibrate supplier is an individual or a company that provides Choline Fenofibrate active pharmaceutical ingredient (API) or Choline Fenofibrate finished formulations upon request. The Choline Fenofibrate suppliers may include Choline Fenofibrate API manufacturers, exporters, distributors and traders.
click here to find a list of Choline Fenofibrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Choline Fenofibrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Choline Fenofibrate active pharmaceutical ingredient (API) in detail. Different forms of Choline Fenofibrate DMFs exist exist since differing nations have different regulations, such as Choline Fenofibrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Choline Fenofibrate DMF submitted to regulatory agencies in the US is known as a USDMF. Choline Fenofibrate USDMF includes data on Choline Fenofibrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Choline Fenofibrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Choline Fenofibrate 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 Choline Fenofibrate Drug Master File in Korea (Choline Fenofibrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Choline Fenofibrate. The MFDS reviews the Choline Fenofibrate KDMF as part of the drug registration process and uses the information provided in the Choline Fenofibrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Choline Fenofibrate 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 Choline Fenofibrate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Choline Fenofibrate suppliers with KDMF on PharmaCompass.
A Choline Fenofibrate written confirmation (Choline Fenofibrate WC) is an official document issued by a regulatory agency to a Choline Fenofibrate manufacturer, verifying that the manufacturing facility of a Choline Fenofibrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Choline Fenofibrate APIs or Choline Fenofibrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Choline Fenofibrate WC (written confirmation) as part of the regulatory process.
click here to find a list of Choline Fenofibrate 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 Choline Fenofibrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Choline Fenofibrate 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 Choline Fenofibrate 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 Choline Fenofibrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Choline Fenofibrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Choline Fenofibrate suppliers with NDC on PharmaCompass.
Choline Fenofibrate 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 Choline Fenofibrate 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 Choline Fenofibrate GMP manufacturer or Choline Fenofibrate GMP API supplier for your needs.
A Choline Fenofibrate CoA (Certificate of Analysis) is a formal document that attests to Choline Fenofibrate's compliance with Choline Fenofibrate specifications and serves as a tool for batch-level quality control.
Choline Fenofibrate CoA mostly includes findings from lab analyses of a specific batch. For each Choline Fenofibrate 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.
Choline Fenofibrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Choline Fenofibrate EP), Choline Fenofibrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Choline Fenofibrate USP).
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