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PharmaCompass offers a list of Ceftizoxime Sodium 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 Ceftizoxime Sodium manufacturer or Ceftizoxime Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ceftizoxime Sodium manufacturer or Ceftizoxime Sodium supplier.
PharmaCompass also assists you with knowing the Ceftizoxime Sodium API Price utilized in the formulation of products. Ceftizoxime Sodium API Price is not always fixed or binding as the Ceftizoxime Sodium Price is obtained through a variety of data sources. The Ceftizoxime Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Epocelin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Epocelin, including repackagers and relabelers. The FDA regulates Epocelin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Epocelin 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 Epocelin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Epocelin supplier is an individual or a company that provides Epocelin active pharmaceutical ingredient (API) or Epocelin finished formulations upon request. The Epocelin suppliers may include Epocelin API manufacturers, exporters, distributors and traders.
click here to find a list of Epocelin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Epocelin DMF (Drug Master File) is a document detailing the whole manufacturing process of Epocelin active pharmaceutical ingredient (API) in detail. Different forms of Epocelin DMFs exist exist since differing nations have different regulations, such as Epocelin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Epocelin DMF submitted to regulatory agencies in the US is known as a USDMF. Epocelin USDMF includes data on Epocelin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Epocelin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Epocelin 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 Epocelin Drug Master File in Japan (Epocelin JDMF) empowers Epocelin 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 Epocelin JDMF during the approval evaluation for pharmaceutical products. At the time of Epocelin 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 Epocelin 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 Epocelin Drug Master File in Korea (Epocelin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Epocelin. The MFDS reviews the Epocelin KDMF as part of the drug registration process and uses the information provided in the Epocelin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Epocelin 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 Epocelin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Epocelin suppliers with KDMF on PharmaCompass.
A Epocelin CEP of the European Pharmacopoeia monograph is often referred to as a Epocelin Certificate of Suitability (COS). The purpose of a Epocelin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Epocelin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Epocelin to their clients by showing that a Epocelin CEP has been issued for it. The manufacturer submits a Epocelin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Epocelin CEP holder for the record. Additionally, the data presented in the Epocelin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Epocelin DMF.
A Epocelin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Epocelin 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 Epocelin suppliers with CEP (COS) on PharmaCompass.
Epocelin 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 Epocelin 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 Epocelin GMP manufacturer or Epocelin GMP API supplier for your needs.
A Epocelin CoA (Certificate of Analysis) is a formal document that attests to Epocelin's compliance with Epocelin specifications and serves as a tool for batch-level quality control.
Epocelin CoA mostly includes findings from lab analyses of a specific batch. For each Epocelin 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.
Epocelin may be tested according to a variety of international standards, such as European Pharmacopoeia (Epocelin EP), Epocelin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Epocelin USP).
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