Synopsis
0
EU WC
0
KDMF
0
FDA Orange Book
DRUG PRODUCT COMPOSITIONS
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Data Compilation #PharmaFlow
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]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] Drugs in Development
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]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]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Evonik
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]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kirsch Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Dr. Paul Lohmann GmbH & Co. KGaA
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]Gloria Interchem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]JJ Chemicals
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]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Parenteral
Solubilizers
API Stability Enhancers
Topical
Emulsifying Agents
Thickeners and Stabilizers
Surfactant & Foaming Agents
Fillers, Diluents & Binders
Film Formers & Plasticizers
Controlled & Modified Release
Direct Compression
Co-Processed Excipients
Rheology Modifiers
Disintegrants & Superdisintegrants
Digital Content
NEWS #PharmaBuzz
Global Sales Information
Market Place
FDF DOSSIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
27
PharmaCompass offers a list of Dextrans API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Dextrans manufacturer or Dextrans supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dextrans manufacturer or Dextrans supplier.
A Rondex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rondex, including repackagers and relabelers. The FDA regulates Rondex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rondex 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 Rondex manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Rondex supplier is an individual or a company that provides Rondex active pharmaceutical ingredient (API) or Rondex finished formulations upon request. The Rondex suppliers may include Rondex API manufacturers, exporters, distributors and traders.
click here to find a list of Rondex suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Rondex DMF (Drug Master File) is a document detailing the whole manufacturing process of Rondex active pharmaceutical ingredient (API) in detail. Different forms of Rondex DMFs exist exist since differing nations have different regulations, such as Rondex USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rondex DMF submitted to regulatory agencies in the US is known as a USDMF. Rondex USDMF includes data on Rondex's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rondex USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rondex 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 Rondex Drug Master File in Japan (Rondex JDMF) empowers Rondex 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 Rondex JDMF during the approval evaluation for pharmaceutical products. At the time of Rondex 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 Rondex suppliers with JDMF on PharmaCompass.
A Rondex CEP of the European Pharmacopoeia monograph is often referred to as a Rondex Certificate of Suitability (COS). The purpose of a Rondex CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Rondex EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Rondex to their clients by showing that a Rondex CEP has been issued for it. The manufacturer submits a Rondex CEP (COS) as part of the market authorization procedure, and it takes on the role of a Rondex CEP holder for the record. Additionally, the data presented in the Rondex CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Rondex DMF.
A Rondex CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Rondex 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 Rondex suppliers with CEP (COS) 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 Rondex as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Rondex 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 Rondex 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 Rondex and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Rondex NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Rondex suppliers with NDC on PharmaCompass.
Rondex 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 Rondex GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Rondex GMP manufacturer or Rondex GMP API supplier for your needs.
A Rondex CoA (Certificate of Analysis) is a formal document that attests to Rondex's compliance with Rondex specifications and serves as a tool for batch-level quality control.
Rondex CoA mostly includes findings from lab analyses of a specific batch. For each Rondex 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.
Rondex may be tested according to a variety of international standards, such as European Pharmacopoeia (Rondex EP), Rondex JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rondex USP).
