Synopsis
0
CEP/COS
0
JDMF
0
VMF
0
Europe
0
Canada
0
Australia
0
South Africa
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONSUS Medicaid
NA
Annual Reports
NA
Regulatory FDF Prices
NA
0
FDF
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
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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API Imports and Exports
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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26
PharmaCompass offers a list of Choline Fenofibrate 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 Choline Fenofibrate manufacturer or Choline Fenofibrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Choline Fenofibrate manufacturer or Choline Fenofibrate supplier.
PharmaCompass also assists you with knowing the Choline Fenofibrate API Price utilized in the formulation of products. Choline Fenofibrate API Price is not always fixed or binding as the Choline Fenofibrate Price is obtained through a variety of data sources. The Choline Fenofibrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Fenofibrate Choline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fenofibrate Choline, including repackagers and relabelers. The FDA regulates Fenofibrate Choline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fenofibrate Choline 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 Fenofibrate Choline manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fenofibrate Choline supplier is an individual or a company that provides Fenofibrate Choline active pharmaceutical ingredient (API) or Fenofibrate Choline finished formulations upon request. The Fenofibrate Choline suppliers may include Fenofibrate Choline API manufacturers, exporters, distributors and traders.
click here to find a list of Fenofibrate Choline suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fenofibrate Choline DMF (Drug Master File) is a document detailing the whole manufacturing process of Fenofibrate Choline active pharmaceutical ingredient (API) in detail. Different forms of Fenofibrate Choline DMFs exist exist since differing nations have different regulations, such as Fenofibrate Choline USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fenofibrate Choline DMF submitted to regulatory agencies in the US is known as a USDMF. Fenofibrate Choline USDMF includes data on Fenofibrate Choline's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fenofibrate Choline USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fenofibrate Choline 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 Fenofibrate Choline Drug Master File in Korea (Fenofibrate Choline KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Fenofibrate Choline. The MFDS reviews the Fenofibrate Choline KDMF as part of the drug registration process and uses the information provided in the Fenofibrate Choline KDMF to evaluate the safety and efficacy of the drug.
After submitting a Fenofibrate Choline 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 Fenofibrate Choline API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Fenofibrate Choline suppliers with KDMF on PharmaCompass.
A Fenofibrate Choline written confirmation (Fenofibrate Choline WC) is an official document issued by a regulatory agency to a Fenofibrate Choline manufacturer, verifying that the manufacturing facility of a Fenofibrate Choline active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Fenofibrate Choline APIs or Fenofibrate Choline finished pharmaceutical products to another nation, regulatory agencies frequently require a Fenofibrate Choline WC (written confirmation) as part of the regulatory process.
click here to find a list of Fenofibrate Choline 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 Fenofibrate Choline as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Fenofibrate Choline 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 Fenofibrate Choline 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 Fenofibrate Choline and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fenofibrate Choline NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Fenofibrate Choline suppliers with NDC on PharmaCompass.
Fenofibrate Choline 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 Fenofibrate Choline 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 Fenofibrate Choline GMP manufacturer or Fenofibrate Choline GMP API supplier for your needs.
A Fenofibrate Choline CoA (Certificate of Analysis) is a formal document that attests to Fenofibrate Choline's compliance with Fenofibrate Choline specifications and serves as a tool for batch-level quality control.
Fenofibrate Choline CoA mostly includes findings from lab analyses of a specific batch. For each Fenofibrate Choline 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.
Fenofibrate Choline may be tested according to a variety of international standards, such as European Pharmacopoeia (Fenofibrate Choline EP), Fenofibrate Choline JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fenofibrate Choline USP).
