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API SUPPLIERS
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Century has been an API manufacturer for over 40 years & is the partner of choice for multipurpose custom manufacturing projects.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
Mesochem is focused on incessant innovation along with the R&D of new APIs.
Sumar Biotech work together to Innovate & Manufacture Semi-synthetic, Synthetic & Fermentation API.
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USDMF
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Amphotericin B 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 Amphotericin B manufacturer or Amphotericin B supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Amphotericin B manufacturer or Amphotericin B supplier.
PharmaCompass also assists you with knowing the Amphotericin B API Price utilized in the formulation of products. Amphotericin B API Price is not always fixed or binding as the Amphotericin B Price is obtained through a variety of data sources. The Amphotericin B Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Fungisome manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fungisome, including repackagers and relabelers. The FDA regulates Fungisome manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fungisome 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 Fungisome manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fungisome supplier is an individual or a company that provides Fungisome active pharmaceutical ingredient (API) or Fungisome finished formulations upon request. The Fungisome suppliers may include Fungisome API manufacturers, exporters, distributors and traders.
click here to find a list of Fungisome suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fungisome DMF (Drug Master File) is a document detailing the whole manufacturing process of Fungisome active pharmaceutical ingredient (API) in detail. Different forms of Fungisome DMFs exist exist since differing nations have different regulations, such as Fungisome USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fungisome DMF submitted to regulatory agencies in the US is known as a USDMF. Fungisome USDMF includes data on Fungisome's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fungisome USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fungisome 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 Fungisome Drug Master File in Japan (Fungisome JDMF) empowers Fungisome 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 Fungisome JDMF during the approval evaluation for pharmaceutical products. At the time of Fungisome 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 Fungisome 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 Fungisome Drug Master File in Korea (Fungisome KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Fungisome. The MFDS reviews the Fungisome KDMF as part of the drug registration process and uses the information provided in the Fungisome KDMF to evaluate the safety and efficacy of the drug.
After submitting a Fungisome 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 Fungisome API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Fungisome suppliers with KDMF on PharmaCompass.
A Fungisome CEP of the European Pharmacopoeia monograph is often referred to as a Fungisome Certificate of Suitability (COS). The purpose of a Fungisome CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Fungisome EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Fungisome to their clients by showing that a Fungisome CEP has been issued for it. The manufacturer submits a Fungisome CEP (COS) as part of the market authorization procedure, and it takes on the role of a Fungisome CEP holder for the record. Additionally, the data presented in the Fungisome CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Fungisome DMF.
A Fungisome CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Fungisome 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 Fungisome 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 Fungisome as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Fungisome 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 Fungisome 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 Fungisome and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fungisome NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Fungisome suppliers with NDC on PharmaCompass.
Fungisome 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 Fungisome 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 Fungisome GMP manufacturer or Fungisome GMP API supplier for your needs.
A Fungisome CoA (Certificate of Analysis) is a formal document that attests to Fungisome's compliance with Fungisome specifications and serves as a tool for batch-level quality control.
Fungisome CoA mostly includes findings from lab analyses of a specific batch. For each Fungisome 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.
Fungisome may be tested according to a variety of international standards, such as European Pharmacopoeia (Fungisome EP), Fungisome JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fungisome USP).
