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API SUPPLIERS
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USDMF
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DOSAGE - FOR SUSPENSION;ORAL - 500MG/5ML
USFDA APPLICATION NUMBER - 202091
DOSAGE - CAPSULE;ORAL - 400MG
USFDA APPLICATION NUMBER - 203195
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
54
PharmaCompass offers a list of Cefixime API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Cefixime manufacturer or Cefixime supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cefixime manufacturer or Cefixime supplier.
A Cefspan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cefspan, including repackagers and relabelers. The FDA regulates Cefspan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cefspan 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 Cefspan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Cefspan supplier is an individual or a company that provides Cefspan active pharmaceutical ingredient (API) or Cefspan finished formulations upon request. The Cefspan suppliers may include Cefspan API manufacturers, exporters, distributors and traders.
click here to find a list of Cefspan suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Cefspan DMF (Drug Master File) is a document detailing the whole manufacturing process of Cefspan active pharmaceutical ingredient (API) in detail. Different forms of Cefspan DMFs exist exist since differing nations have different regulations, such as Cefspan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cefspan DMF submitted to regulatory agencies in the US is known as a USDMF. Cefspan USDMF includes data on Cefspan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cefspan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cefspan 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 Cefspan Drug Master File in Japan (Cefspan JDMF) empowers Cefspan 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 Cefspan JDMF during the approval evaluation for pharmaceutical products. At the time of Cefspan 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 Cefspan 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 Cefspan Drug Master File in Korea (Cefspan KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cefspan. The MFDS reviews the Cefspan KDMF as part of the drug registration process and uses the information provided in the Cefspan KDMF to evaluate the safety and efficacy of the drug.
After submitting a Cefspan 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 Cefspan API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Cefspan suppliers with KDMF on PharmaCompass.
A Cefspan CEP of the European Pharmacopoeia monograph is often referred to as a Cefspan Certificate of Suitability (COS). The purpose of a Cefspan CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cefspan EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cefspan to their clients by showing that a Cefspan CEP has been issued for it. The manufacturer submits a Cefspan CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cefspan CEP holder for the record. Additionally, the data presented in the Cefspan CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cefspan DMF.
A Cefspan CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cefspan 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 Cefspan suppliers with CEP (COS) on PharmaCompass.
A Cefspan written confirmation (Cefspan WC) is an official document issued by a regulatory agency to a Cefspan manufacturer, verifying that the manufacturing facility of a Cefspan active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cefspan APIs or Cefspan finished pharmaceutical products to another nation, regulatory agencies frequently require a Cefspan WC (written confirmation) as part of the regulatory process.
click here to find a list of Cefspan suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Cefspan as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cefspan API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Cefspan as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Cefspan and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cefspan NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cefspan suppliers with NDC on PharmaCompass.
Cefspan 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 Cefspan GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Cefspan GMP manufacturer or Cefspan GMP API supplier for your needs.
A Cefspan CoA (Certificate of Analysis) is a formal document that attests to Cefspan's compliance with Cefspan specifications and serves as a tool for batch-level quality control.
Cefspan CoA mostly includes findings from lab analyses of a specific batch. For each Cefspan 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.
Cefspan may be tested according to a variety of international standards, such as European Pharmacopoeia (Cefspan EP), Cefspan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cefspan USP).
