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