Synopsis
0
CEP/COS
0
EU WC
0
KDMF
0
VMF
0
API
0
FDF
0
Europe
0
Canada
0
Australia
0
South Africa
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
Axplora- The partner of choice for complex APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2012-10-23
Pay. Date : 2012-11-28
DMF Number : 16492
Submission : 2003-03-26
Status :
Type : II
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
Axplora- The partner of choice for complex APIs.
About the Company : Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-qual...
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]DRUG PRODUCT COMPOSITIONS
DOSAGE - LOTION;TOPICAL - 0.05%
USFDA APPLICATION NUMBER - 13790
DOSAGE - TAPE;TOPICAL - 0.004MG/SQ CM
USFDA APPLICATION NUMBER - 16455
Related Excipient Companies
Nanjing Well Pharmaceutical
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]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]Kerry
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]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Topical
Film Formers & Plasticizers
Coating Systems & Additives
Parenteral
Co-Processed Excipients
Solubilizers
Lubricants & Glidants
Thickeners and Stabilizers
Fillers, Diluents & Binders
Emulsifying Agents
Controlled & Modified Release
Granulation
Direct Compression
Surfactant & Foaming Agents
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]REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Flurandrenolide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Flurandrenolide, including repackagers and relabelers. The FDA regulates Flurandrenolide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Flurandrenolide 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 Flurandrenolide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Flurandrenolide supplier is an individual or a company that provides Flurandrenolide active pharmaceutical ingredient (API) or Flurandrenolide finished formulations upon request. The Flurandrenolide suppliers may include Flurandrenolide API manufacturers, exporters, distributors and traders.
click here to find a list of Flurandrenolide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Flurandrenolide DMF (Drug Master File) is a document detailing the whole manufacturing process of Flurandrenolide active pharmaceutical ingredient (API) in detail. Different forms of Flurandrenolide DMFs exist exist since differing nations have different regulations, such as Flurandrenolide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Flurandrenolide DMF submitted to regulatory agencies in the US is known as a USDMF. Flurandrenolide USDMF includes data on Flurandrenolide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Flurandrenolide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Flurandrenolide 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 Flurandrenolide Drug Master File in Japan (Flurandrenolide JDMF) empowers Flurandrenolide 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 Flurandrenolide JDMF during the approval evaluation for pharmaceutical products. At the time of Flurandrenolide 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 Flurandrenolide suppliers with JDMF 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 Flurandrenolide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Flurandrenolide 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 Flurandrenolide 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 Flurandrenolide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Flurandrenolide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Flurandrenolide suppliers with NDC on PharmaCompass.
Flurandrenolide 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 Flurandrenolide 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 Flurandrenolide GMP manufacturer or Flurandrenolide GMP API supplier for your needs.
A Flurandrenolide CoA (Certificate of Analysis) is a formal document that attests to Flurandrenolide's compliance with Flurandrenolide specifications and serves as a tool for batch-level quality control.
Flurandrenolide CoA mostly includes findings from lab analyses of a specific batch. For each Flurandrenolide 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.
Flurandrenolide may be tested according to a variety of international standards, such as European Pharmacopoeia (Flurandrenolide EP), Flurandrenolide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Flurandrenolide USP).
LOOKING FOR A SUPPLIER?
