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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
CEP/COS 
EU-WC
NDC
KDMF
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
CEP/COS
JDMF
NDC
Canada D...
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Jai Radhe Sales is your partner for all your sourcing needs.
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
CEP/COS
NDC
KDMF
ASMF
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
AMI Lifesciences is Driven by Chemistry. Powered by People.
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USDMF
IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
GDUFA
DMF Review : Complete
Rev. Date : 2024-02-05
Pay. Date : 2023-12-22
DMF Number : 36535
Submission : 2022-01-05
Status :
Type : II
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11194
Submission : 1994-11-09
Status :
Type : II
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : Complete
Rev. Date : 2017-08-17
Pay. Date : 2017-07-31
DMF Number : 19119
Submission : 2006-01-16
Status :
Type : II
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15469
Submission : 2001-06-04
Status :
Type : II
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API Imports and Exports
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Drugs in Development
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Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
Regulatory Info :
Registration Country : Italy
Brand Name : FENOFIBRATE PENSA PHARMA
Dosage Form : Film-Coated Tablets
Dosage Strength : 145 mg
Packaging : 30 UNITS 145 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
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DOSAGE - TABLET;ORAL - 160MG
USFDA APPLICATION NUMBER - 21350
DOSAGE - CAPSULE;ORAL - 150MG
USFDA APPLICATION NUMBER - 21612
DOSAGE - CAPSULE;ORAL - 50MG
USFDA APPLICATION NUMBER - 21612
DOSAGE - TABLET;ORAL - 145MG
USFDA APPLICATION NUMBER - 21656
DOSAGE - TABLET;ORAL - 48MG
USFDA APPLICATION NUMBER - 21656
DOSAGE - CAPSULE;ORAL - 130MG
USFDA APPLICATION NUMBER - 21695
DOSAGE - CAPSULE;ORAL - 30MG **Federal Regist...DOSAGE - CAPSULE;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21695
DOSAGE - CAPSULE;ORAL - 43MG
USFDA APPLICATION NUMBER - 21695
DOSAGE - CAPSULE;ORAL - 90MG
USFDA APPLICATION NUMBER - 21695
DOSAGE - TABLET;ORAL - 105MG
USFDA APPLICATION NUMBER - 22418
DOSAGE - TABLET;ORAL - 35MG
USFDA APPLICATION NUMBER - 22418
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Minakem
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
Dosage Form : Capsule
Grade : Oral
Brand Name : Sodium Stearyl Fumarate G...
Application : Lubricants & Glidants
Excipient Details : Sodium Stearyl Fumarate is used as a lubricant in OSDs to reduce the friction and the adhesion. It also provides tablet strength & disintegration.
Pharmacopoeia Ref : USP, EP, ICH, Q7GMP
Technical Specs : NA
Ingredient(s) : Sodium Stearyl Fumarate
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REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
ABOUT THIS PAGE
A Fenofibrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fenofibrate, including repackagers and relabelers. The FDA regulates Fenofibrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 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 Fenofibrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fenofibrate supplier is an individual or a company that provides Fenofibrate active pharmaceutical ingredient (API) or Fenofibrate finished formulations upon request. The Fenofibrate suppliers may include Fenofibrate API manufacturers, exporters, distributors and traders.
click here to find a list of Fenofibrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fenofibrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Fenofibrate active pharmaceutical ingredient (API) in detail. Different forms of Fenofibrate DMFs exist exist since differing nations have different regulations, such as Fenofibrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fenofibrate DMF submitted to regulatory agencies in the US is known as a USDMF. Fenofibrate USDMF includes data on Fenofibrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fenofibrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fenofibrate suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Fenofibrate Drug Master File in Japan (Fenofibrate JDMF) empowers Fenofibrate API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Fenofibrate JDMF during the approval evaluation for pharmaceutical products. At the time of Fenofibrate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Fenofibrate suppliers with JDMF 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 Drug Master File in Korea (Fenofibrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Fenofibrate. The MFDS reviews the Fenofibrate KDMF as part of the drug registration process and uses the information provided in the Fenofibrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a 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 Fenofibrate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Fenofibrate suppliers with KDMF on PharmaCompass.
A Fenofibrate CEP of the European Pharmacopoeia monograph is often referred to as a Fenofibrate Certificate of Suitability (COS). The purpose of a Fenofibrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Fenofibrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Fenofibrate to their clients by showing that a Fenofibrate CEP has been issued for it. The manufacturer submits a Fenofibrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Fenofibrate CEP holder for the record. Additionally, the data presented in the Fenofibrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Fenofibrate DMF.
A Fenofibrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Fenofibrate 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 Fenofibrate suppliers with CEP (COS) on PharmaCompass.
A Fenofibrate written confirmation (Fenofibrate WC) is an official document issued by a regulatory agency to a Fenofibrate manufacturer, verifying that the manufacturing facility of a Fenofibrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Fenofibrate APIs or Fenofibrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Fenofibrate WC (written confirmation) as part of the regulatory process.
click here to find a list of 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 Fenofibrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 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 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 Fenofibrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fenofibrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Fenofibrate suppliers with NDC on PharmaCompass.
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 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 Fenofibrate GMP manufacturer or Fenofibrate GMP API supplier for your needs.
A Fenofibrate CoA (Certificate of Analysis) is a formal document that attests to Fenofibrate's compliance with Fenofibrate specifications and serves as a tool for batch-level quality control.
Fenofibrate CoA mostly includes findings from lab analyses of a specific batch. For each 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.
Fenofibrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Fenofibrate EP), Fenofibrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fenofibrate USP).
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