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