Synopsis
0
VMF
0
Australia
DRUG PRODUCT COMPOSITIONS0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
Axplora- The partner of choice for complex APIs.
Click Us!
EU-WC
NDC
KDMF
EU, CA, ...
With Fermion, start the journey of your innovative API.
CEP/COS
NDC
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
CEP/COS
JDMF
NDC
KDMF
CA, CN
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API Imports and Exports
Upgrade, download data, analyse, strategize, subscribe with us 
INTERMEDIATES SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - TABLET;ORAL - 150MG **Federal Regist...DOSAGE - TABLET;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19151
DOSAGE - TABLET;ORAL - 225MG **Federal Regist...DOSAGE - TABLET;ORAL - 225MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19151
DOSAGE - TABLET;ORAL - 300MG **Federal Regist...DOSAGE - TABLET;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19151
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 225...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 225MG
USFDA APPLICATION NUMBER - 21416
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 325...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 325MG
USFDA APPLICATION NUMBER - 21416
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 425...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 425MG
USFDA APPLICATION NUMBER - 21416
Related Excipient Companies
Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seqens
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Boai NKY Pharmaceuticals Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ACG Worldwide
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Aeon Procare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Alcedo Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Corel Pharma Chem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures Pvt Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kima Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Bold Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nomisma Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qianhao Chemical (Hebei) Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qualicaps
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Welltone Material Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ulanqab Kema New Material
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Coating Systems & Additives
Direct Compression
Disintegrants & Superdisintegrants
Granulation
Controlled & Modified Release
Thickeners and Stabilizers
Solubilizers
Lubricants & Glidants
Co-Processed Excipients
Film Formers & Plasticizers
Topical
Taste Masking
Parenteral
Chewable & Orodispersible Aids
Emulsifying Agents
Empty Capsules
API Stability Enhancers
Coloring Agents
Rheology Modifiers
Vegetarian Capsules
Surfactant & Foaming Agents
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
ABOUT THIS PAGE
A Propafenone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Propafenone, including repackagers and relabelers. The FDA regulates Propafenone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Propafenone 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 Propafenone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Propafenone supplier is an individual or a company that provides Propafenone active pharmaceutical ingredient (API) or Propafenone finished formulations upon request. The Propafenone suppliers may include Propafenone API manufacturers, exporters, distributors and traders.
click here to find a list of Propafenone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Propafenone DMF (Drug Master File) is a document detailing the whole manufacturing process of Propafenone active pharmaceutical ingredient (API) in detail. Different forms of Propafenone DMFs exist exist since differing nations have different regulations, such as Propafenone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Propafenone DMF submitted to regulatory agencies in the US is known as a USDMF. Propafenone USDMF includes data on Propafenone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Propafenone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Propafenone 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 Propafenone Drug Master File in Japan (Propafenone JDMF) empowers Propafenone 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 Propafenone JDMF during the approval evaluation for pharmaceutical products. At the time of Propafenone 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 Propafenone 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 Propafenone Drug Master File in Korea (Propafenone KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Propafenone. The MFDS reviews the Propafenone KDMF as part of the drug registration process and uses the information provided in the Propafenone KDMF to evaluate the safety and efficacy of the drug.
After submitting a Propafenone 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 Propafenone API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Propafenone suppliers with KDMF on PharmaCompass.
A Propafenone CEP of the European Pharmacopoeia monograph is often referred to as a Propafenone Certificate of Suitability (COS). The purpose of a Propafenone CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Propafenone EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Propafenone to their clients by showing that a Propafenone CEP has been issued for it. The manufacturer submits a Propafenone CEP (COS) as part of the market authorization procedure, and it takes on the role of a Propafenone CEP holder for the record. Additionally, the data presented in the Propafenone CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Propafenone DMF.
A Propafenone CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Propafenone 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 Propafenone suppliers with CEP (COS) on PharmaCompass.
A Propafenone written confirmation (Propafenone WC) is an official document issued by a regulatory agency to a Propafenone manufacturer, verifying that the manufacturing facility of a Propafenone active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Propafenone APIs or Propafenone finished pharmaceutical products to another nation, regulatory agencies frequently require a Propafenone WC (written confirmation) as part of the regulatory process.
click here to find a list of Propafenone 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 Propafenone as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Propafenone 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 Propafenone 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 Propafenone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Propafenone NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Propafenone suppliers with NDC on PharmaCompass.
Propafenone 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 Propafenone 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 Propafenone GMP manufacturer or Propafenone GMP API supplier for your needs.
A Propafenone CoA (Certificate of Analysis) is a formal document that attests to Propafenone's compliance with Propafenone specifications and serves as a tool for batch-level quality control.
Propafenone CoA mostly includes findings from lab analyses of a specific batch. For each Propafenone 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.
Propafenone may be tested according to a variety of international standards, such as European Pharmacopoeia (Propafenone EP), Propafenone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Propafenone USP).
LOOKING FOR A SUPPLIER?
