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