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
0
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/FDF Prices: Book a Demo to explore the features and consider upgrading later
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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Fillers, Diluents & Binders
Controlled & Modified Release
Lubricants & Glidants
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Surfactant & Foaming Agents
Chewable & Orodispersible Aids
Parenteral
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ABOUT THIS PAGE
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 TRILIPIX manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of TRILIPIX, including repackagers and relabelers. The FDA regulates TRILIPIX manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. TRILIPIX 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 TRILIPIX manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A TRILIPIX supplier is an individual or a company that provides TRILIPIX active pharmaceutical ingredient (API) or TRILIPIX finished formulations upon request. The TRILIPIX suppliers may include TRILIPIX API manufacturers, exporters, distributors and traders.
click here to find a list of TRILIPIX suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A TRILIPIX DMF (Drug Master File) is a document detailing the whole manufacturing process of TRILIPIX active pharmaceutical ingredient (API) in detail. Different forms of TRILIPIX DMFs exist exist since differing nations have different regulations, such as TRILIPIX USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A TRILIPIX DMF submitted to regulatory agencies in the US is known as a USDMF. TRILIPIX USDMF includes data on TRILIPIX's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The TRILIPIX USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of TRILIPIX 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 TRILIPIX Drug Master File in Korea (TRILIPIX KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of TRILIPIX. The MFDS reviews the TRILIPIX KDMF as part of the drug registration process and uses the information provided in the TRILIPIX KDMF to evaluate the safety and efficacy of the drug.
After submitting a TRILIPIX 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 TRILIPIX API can apply through the Korea Drug Master File (KDMF).
click here to find a list of TRILIPIX suppliers with KDMF on PharmaCompass.
A TRILIPIX written confirmation (TRILIPIX WC) is an official document issued by a regulatory agency to a TRILIPIX manufacturer, verifying that the manufacturing facility of a TRILIPIX active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting TRILIPIX APIs or TRILIPIX finished pharmaceutical products to another nation, regulatory agencies frequently require a TRILIPIX WC (written confirmation) as part of the regulatory process.
click here to find a list of TRILIPIX 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 TRILIPIX as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for TRILIPIX 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 TRILIPIX 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 TRILIPIX and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a TRILIPIX NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of TRILIPIX suppliers with NDC on PharmaCompass.
TRILIPIX 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 TRILIPIX 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 TRILIPIX GMP manufacturer or TRILIPIX GMP API supplier for your needs.
A TRILIPIX CoA (Certificate of Analysis) is a formal document that attests to TRILIPIX's compliance with TRILIPIX specifications and serves as a tool for batch-level quality control.
TRILIPIX CoA mostly includes findings from lab analyses of a specific batch. For each TRILIPIX 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.
TRILIPIX may be tested according to a variety of international standards, such as European Pharmacopoeia (TRILIPIX EP), TRILIPIX JP (Japanese Pharmacopeia) and the US Pharmacopoeia (TRILIPIX USP).
