Synopsis
0
CEP/COS
0
JDMF
0
EU WC
0
KDMF
0
VMF
0
Europe
0
Canada
0
Australia
0
South Africa
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
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]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 
DRUG PRODUCT COMPOSITIONS
DOSAGE - CREAM;TOPICAL - EQ 85MG BASE/GM
USFDA APPLICATION NUMBER - 16763
DOSAGE - FOR SOLUTION;TOPICAL - 5%
USFDA APPLICATION NUMBER - 19832
Related Excipient Companies
Actylis
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]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Topical
Parenteral
Controlled & Modified Release
Film Formers & Plasticizers
Lubricants & Glidants
Granulation
Direct Compression
Surfactant & Foaming Agents
Coating Systems & Additives
Emulsifying Agents
Solubilizers
Thickeners and Stabilizers
Digital Content
DATA COMPILATION #PharmaFlow
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
ABOUT THIS PAGE
A Mafenide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mafenide, including repackagers and relabelers. The FDA regulates Mafenide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mafenide 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 Mafenide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mafenide supplier is an individual or a company that provides Mafenide active pharmaceutical ingredient (API) or Mafenide finished formulations upon request. The Mafenide suppliers may include Mafenide API manufacturers, exporters, distributors and traders.
click here to find a list of Mafenide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mafenide DMF (Drug Master File) is a document detailing the whole manufacturing process of Mafenide active pharmaceutical ingredient (API) in detail. Different forms of Mafenide DMFs exist exist since differing nations have different regulations, such as Mafenide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mafenide DMF submitted to regulatory agencies in the US is known as a USDMF. Mafenide USDMF includes data on Mafenide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mafenide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mafenide suppliers with USDMF 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 Mafenide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Mafenide 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 Mafenide 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 Mafenide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Mafenide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Mafenide suppliers with NDC on PharmaCompass.
Mafenide 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 Mafenide 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 Mafenide GMP manufacturer or Mafenide GMP API supplier for your needs.
A Mafenide CoA (Certificate of Analysis) is a formal document that attests to Mafenide's compliance with Mafenide specifications and serves as a tool for batch-level quality control.
Mafenide CoA mostly includes findings from lab analyses of a specific batch. For each Mafenide 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.
Mafenide may be tested according to a variety of international standards, such as European Pharmacopoeia (Mafenide EP), Mafenide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Mafenide USP).
LOOKING FOR A SUPPLIER?
