X
API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
Other Certificates
0
Other Suppliers
0
0
USA (Orange Book)
0
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
0
Annual Reports
0
0
USFDA Orange Book Patents
0
USFDA Exclusivities
0
Blog #PharmaFlow
0
News
0
EDQM
0
USP
0
JP
0
Other Listed Suppliers
0
0
61
PharmaCompass offers a list of Cetraxate 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 Cetraxate manufacturer or Cetraxate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cetraxate manufacturer or Cetraxate supplier.
PharmaCompass also assists you with knowing the Cetraxate API Price utilized in the formulation of products. Cetraxate API Price is not always fixed or binding as the Cetraxate Price is obtained through a variety of data sources. The Cetraxate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Cetraxate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cetraxate, including repackagers and relabelers. The FDA regulates Cetraxate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cetraxate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Cetraxate supplier is an individual or a company that provides Cetraxate active pharmaceutical ingredient (API) or Cetraxate finished formulations upon request. The Cetraxate suppliers may include Cetraxate API manufacturers, exporters, distributors and traders.
click here to find a list of Cetraxate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cetraxate DMF (Drug Master File) is a document detailing the whole manufacturing process of Cetraxate active pharmaceutical ingredient (API) in detail. Different forms of Cetraxate DMFs exist exist since differing nations have different regulations, such as Cetraxate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cetraxate DMF submitted to regulatory agencies in the US is known as a USDMF. Cetraxate USDMF includes data on Cetraxate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cetraxate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cetraxate 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 Cetraxate Drug Master File in Japan (Cetraxate JDMF) empowers Cetraxate 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 Cetraxate JDMF during the approval evaluation for pharmaceutical products. At the time of Cetraxate 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 Cetraxate suppliers with JDMF on PharmaCompass.
Cetraxate 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 Cetraxate 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 Cetraxate GMP manufacturer or Cetraxate GMP API supplier for your needs.
A Cetraxate CoA (Certificate of Analysis) is a formal document that attests to Cetraxate's compliance with Cetraxate specifications and serves as a tool for batch-level quality control.
Cetraxate CoA mostly includes findings from lab analyses of a specific batch. For each Cetraxate 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.
Cetraxate may be tested according to a variety of international standards, such as European Pharmacopoeia (Cetraxate EP), Cetraxate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cetraxate USP).
Market Place
