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