Synopsis
0
USDMF
0
CEP/COS
0
NDC API
0
VMF
0
EDQM
0
USP
0
JP
0
Others
0
FDF Dossiers
0
FDA Orange Book
0
Europe
0
Canada
0
Australia
0
South Africa
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS
0
US Patents
0
US Exclusivities
0
Health Canada Patents
US Medicaid
NA
Annual Reports
NA
Regulatory FDF Prices
NA
0
API
0
FDF
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]
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
Digital Content
NEWS #PharmaBuzz
ABOUT THIS PAGE
32
PharmaCompass offers a list of Zaltoprofen 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 Zaltoprofen manufacturer or Zaltoprofen supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Zaltoprofen manufacturer or Zaltoprofen supplier.
PharmaCompass also assists you with knowing the Zaltoprofen API Price utilized in the formulation of products. Zaltoprofen API Price is not always fixed or binding as the Zaltoprofen Price is obtained through a variety of data sources. The Zaltoprofen Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Peon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Peon, including repackagers and relabelers. The FDA regulates Peon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Peon 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 Peon manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Peon supplier is an individual or a company that provides Peon active pharmaceutical ingredient (API) or Peon finished formulations upon request. The Peon suppliers may include Peon API manufacturers, exporters, distributors and traders.
click here to find a list of Peon 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 Peon Drug Master File in Japan (Peon JDMF) empowers Peon 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 Peon JDMF during the approval evaluation for pharmaceutical products. At the time of Peon 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 Peon 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 Peon Drug Master File in Korea (Peon KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Peon. The MFDS reviews the Peon KDMF as part of the drug registration process and uses the information provided in the Peon KDMF to evaluate the safety and efficacy of the drug.
After submitting a Peon 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 Peon API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Peon suppliers with KDMF on PharmaCompass.
A Peon written confirmation (Peon WC) is an official document issued by a regulatory agency to a Peon manufacturer, verifying that the manufacturing facility of a Peon active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Peon APIs or Peon finished pharmaceutical products to another nation, regulatory agencies frequently require a Peon WC (written confirmation) as part of the regulatory process.
click here to find a list of Peon suppliers with Written Confirmation (WC) on PharmaCompass.
Peon 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 Peon 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 Peon GMP manufacturer or Peon GMP API supplier for your needs.
A Peon CoA (Certificate of Analysis) is a formal document that attests to Peon's compliance with Peon specifications and serves as a tool for batch-level quality control.
Peon CoA mostly includes findings from lab analyses of a specific batch. For each Peon 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.
Peon may be tested according to a variety of international standards, such as European Pharmacopoeia (Peon EP), Peon JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Peon USP).
