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