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ABOUT THIS PAGE
A Cefpirome Sulphate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cefpirome Sulphate, including repackagers and relabelers. The FDA regulates Cefpirome Sulphate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cefpirome Sulphate 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 Cefpirome Sulphate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cefpirome Sulphate supplier is an individual or a company that provides Cefpirome Sulphate active pharmaceutical ingredient (API) or Cefpirome Sulphate finished formulations upon request. The Cefpirome Sulphate suppliers may include Cefpirome Sulphate API manufacturers, exporters, distributors and traders.
click here to find a list of Cefpirome Sulphate 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 Cefpirome Sulphate Drug Master File in Japan (Cefpirome Sulphate JDMF) empowers Cefpirome Sulphate 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 Cefpirome Sulphate JDMF during the approval evaluation for pharmaceutical products. At the time of Cefpirome Sulphate 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 Cefpirome Sulphate 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 Cefpirome Sulphate Drug Master File in Korea (Cefpirome Sulphate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cefpirome Sulphate. The MFDS reviews the Cefpirome Sulphate KDMF as part of the drug registration process and uses the information provided in the Cefpirome Sulphate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Cefpirome Sulphate 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 Cefpirome Sulphate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Cefpirome Sulphate suppliers with KDMF on PharmaCompass.
A Cefpirome Sulphate written confirmation (Cefpirome Sulphate WC) is an official document issued by a regulatory agency to a Cefpirome Sulphate manufacturer, verifying that the manufacturing facility of a Cefpirome Sulphate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cefpirome Sulphate APIs or Cefpirome Sulphate finished pharmaceutical products to another nation, regulatory agencies frequently require a Cefpirome Sulphate WC (written confirmation) as part of the regulatory process.
click here to find a list of Cefpirome Sulphate suppliers with Written Confirmation (WC) on PharmaCompass.
Cefpirome Sulphate 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 Cefpirome Sulphate 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 Cefpirome Sulphate GMP manufacturer or Cefpirome Sulphate GMP API supplier for your needs.
A Cefpirome Sulphate CoA (Certificate of Analysis) is a formal document that attests to Cefpirome Sulphate's compliance with Cefpirome Sulphate specifications and serves as a tool for batch-level quality control.
Cefpirome Sulphate CoA mostly includes findings from lab analyses of a specific batch. For each Cefpirome Sulphate 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.
Cefpirome Sulphate may be tested according to a variety of international standards, such as European Pharmacopoeia (Cefpirome Sulphate EP), Cefpirome Sulphate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cefpirome Sulphate USP).
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