Synopsis
0
USDMF
0
KDMF
0
NDC API
0
VMF
0
FDA Orange Book
0
Canada
0
Australia
0
South Africa
DRUG PRODUCT COMPOSITIONS
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
FDF
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
CEP/COS
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Certificate Number : R1-CEP 1998-088 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2004-12-07
Type : Chemical
Substance Number : 636
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
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]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
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]Digital Content
NEWS #PharmaBuzz
Global Sales Information
Market Place
APIs
Reply
10 Jun 2024
Reply
29 Apr 2021
Reply
12 Feb 2021
Reply
12 May 2020
Reply
06 May 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
REF. STANDARDS & IMPURITIES
EDQM
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
17
PharmaCompass offers a list of Propyphenazone API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Propyphenazone manufacturer or Propyphenazone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Propyphenazone manufacturer or Propyphenazone supplier.
PharmaCompass also assists you with knowing the Propyphenazone API Price utilized in the formulation of products. Propyphenazone API Price is not always fixed or binding as the Propyphenazone Price is obtained through a variety of data sources. The Propyphenazone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Budirol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Budirol, including repackagers and relabelers. The FDA regulates Budirol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Budirol 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 Budirol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Budirol supplier is an individual or a company that provides Budirol active pharmaceutical ingredient (API) or Budirol finished formulations upon request. The Budirol suppliers may include Budirol API manufacturers, exporters, distributors and traders.
click here to find a list of Budirol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Budirol Drug Master File in Japan (Budirol JDMF) empowers Budirol 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 Budirol JDMF during the approval evaluation for pharmaceutical products. At the time of Budirol 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 Budirol suppliers with JDMF on PharmaCompass.
A Budirol CEP of the European Pharmacopoeia monograph is often referred to as a Budirol Certificate of Suitability (COS). The purpose of a Budirol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Budirol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Budirol to their clients by showing that a Budirol CEP has been issued for it. The manufacturer submits a Budirol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Budirol CEP holder for the record. Additionally, the data presented in the Budirol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Budirol DMF.
A Budirol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Budirol 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 Budirol suppliers with CEP (COS) on PharmaCompass.
A Budirol written confirmation (Budirol WC) is an official document issued by a regulatory agency to a Budirol manufacturer, verifying that the manufacturing facility of a Budirol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Budirol APIs or Budirol finished pharmaceutical products to another nation, regulatory agencies frequently require a Budirol WC (written confirmation) as part of the regulatory process.
click here to find a list of Budirol suppliers with Written Confirmation (WC) on PharmaCompass.
Budirol 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 Budirol 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 Budirol GMP manufacturer or Budirol GMP API supplier for your needs.
A Budirol CoA (Certificate of Analysis) is a formal document that attests to Budirol's compliance with Budirol specifications and serves as a tool for batch-level quality control.
Budirol CoA mostly includes findings from lab analyses of a specific batch. For each Budirol 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.
Budirol may be tested according to a variety of international standards, such as European Pharmacopoeia (Budirol EP), Budirol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Budirol USP).
Comment (2)
