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Comhony Biotech manufactures fermentation & semi-synthetic APIs which aim at dermatology, anti-biotics; mitochondria & memory health.
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Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
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.
About the Company : Comhony Biotech is dedicated to supplying APIs and nutraceutical ingredients to worldwide clients in the pharmaceutical and nutraceutical sectors. Leveraging its proprietary techno...
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
About the Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs)...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
About the Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological API...
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Fusidic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fusidic Acid, including repackagers and relabelers. The FDA regulates Fusidic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fusidic Acid 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 Fusidic Acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fusidic Acid supplier is an individual or a company that provides Fusidic Acid active pharmaceutical ingredient (API) or Fusidic Acid finished formulations upon request. The Fusidic Acid suppliers may include Fusidic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Fusidic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fusidic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Fusidic Acid active pharmaceutical ingredient (API) in detail. Different forms of Fusidic Acid DMFs exist exist since differing nations have different regulations, such as Fusidic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fusidic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Fusidic Acid USDMF includes data on Fusidic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fusidic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fusidic Acid 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 Fusidic Acid Drug Master File in Korea (Fusidic Acid KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Fusidic Acid. The MFDS reviews the Fusidic Acid KDMF as part of the drug registration process and uses the information provided in the Fusidic Acid KDMF to evaluate the safety and efficacy of the drug.
After submitting a Fusidic Acid 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 Fusidic Acid API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Fusidic Acid suppliers with KDMF on PharmaCompass.
A Fusidic Acid CEP of the European Pharmacopoeia monograph is often referred to as a Fusidic Acid Certificate of Suitability (COS). The purpose of a Fusidic Acid CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Fusidic Acid EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Fusidic Acid to their clients by showing that a Fusidic Acid CEP has been issued for it. The manufacturer submits a Fusidic Acid CEP (COS) as part of the market authorization procedure, and it takes on the role of a Fusidic Acid CEP holder for the record. Additionally, the data presented in the Fusidic Acid CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Fusidic Acid DMF.
A Fusidic Acid CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Fusidic Acid 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 Fusidic Acid 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 Fusidic Acid as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Fusidic Acid 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 Fusidic Acid 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 Fusidic Acid and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fusidic Acid NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Fusidic Acid suppliers with NDC on PharmaCompass.
Fusidic Acid 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 Fusidic Acid 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 Fusidic Acid GMP manufacturer or Fusidic Acid GMP API supplier for your needs.
A Fusidic Acid CoA (Certificate of Analysis) is a formal document that attests to Fusidic Acid's compliance with Fusidic Acid specifications and serves as a tool for batch-level quality control.
Fusidic Acid CoA mostly includes findings from lab analyses of a specific batch. For each Fusidic Acid 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.
Fusidic Acid may be tested according to a variety of international standards, such as European Pharmacopoeia (Fusidic Acid EP), Fusidic Acid JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fusidic Acid USP).
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