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API SUPPLIERS
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USDMF
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DOSAGE - POWDER;INHALATION - 0.05MG/INH;EQ 0....DOSAGE - POWDER;INHALATION - 0.05MG/INH;EQ 0.025MG BASE/INH
USFDA APPLICATION NUMBER - 204275
DOSAGE - POWDER;INHALATION - 0.1MG/INH;EQ 0.0...DOSAGE - POWDER;INHALATION - 0.1MG/INH;EQ 0.025MG BASE/INH
USFDA APPLICATION NUMBER - 204275
DOSAGE - POWDER;INHALATION - 0.2MG/INH;EQ 0.0...DOSAGE - POWDER;INHALATION - 0.2MG/INH;EQ 0.025MG BASE/INH
USFDA APPLICATION NUMBER - 204275
DOSAGE - POWDER;INHALATION - 0.05MG/INH
USFDA APPLICATION NUMBER - 205625
DOSAGE - POWDER;INHALATION - 0.1MG/INH
USFDA APPLICATION NUMBER - 205625
DOSAGE - POWDER;INHALATION - 0.2MG/INH
USFDA APPLICATION NUMBER - 205625
DOSAGE - SPRAY, METERED;NASAL - 0.0275MG/SPRA...DOSAGE - SPRAY, METERED;NASAL - 0.0275MG/SPRAY
USFDA APPLICATION NUMBER - 22051
Related Excipient Companies
Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
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ABOUT THIS PAGE
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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 GSK 685 698 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of GSK 685 698, including repackagers and relabelers. The FDA regulates GSK 685 698 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. GSK 685 698 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 GSK 685 698 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A GSK 685 698 supplier is an individual or a company that provides GSK 685 698 active pharmaceutical ingredient (API) or GSK 685 698 finished formulations upon request. The GSK 685 698 suppliers may include GSK 685 698 API manufacturers, exporters, distributors and traders.
click here to find a list of GSK 685 698 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A GSK 685 698 DMF (Drug Master File) is a document detailing the whole manufacturing process of GSK 685 698 active pharmaceutical ingredient (API) in detail. Different forms of GSK 685 698 DMFs exist exist since differing nations have different regulations, such as GSK 685 698 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A GSK 685 698 DMF submitted to regulatory agencies in the US is known as a USDMF. GSK 685 698 USDMF includes data on GSK 685 698's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The GSK 685 698 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of GSK 685 698 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 GSK 685 698 Drug Master File in Japan (GSK 685 698 JDMF) empowers GSK 685 698 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 GSK 685 698 JDMF during the approval evaluation for pharmaceutical products. At the time of GSK 685 698 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 GSK 685 698 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 GSK 685 698 Drug Master File in Korea (GSK 685 698 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of GSK 685 698. The MFDS reviews the GSK 685 698 KDMF as part of the drug registration process and uses the information provided in the GSK 685 698 KDMF to evaluate the safety and efficacy of the drug.
After submitting a GSK 685 698 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 GSK 685 698 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of GSK 685 698 suppliers with KDMF on PharmaCompass.
A GSK 685 698 CEP of the European Pharmacopoeia monograph is often referred to as a GSK 685 698 Certificate of Suitability (COS). The purpose of a GSK 685 698 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of GSK 685 698 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of GSK 685 698 to their clients by showing that a GSK 685 698 CEP has been issued for it. The manufacturer submits a GSK 685 698 CEP (COS) as part of the market authorization procedure, and it takes on the role of a GSK 685 698 CEP holder for the record. Additionally, the data presented in the GSK 685 698 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the GSK 685 698 DMF.
A GSK 685 698 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. GSK 685 698 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 GSK 685 698 suppliers with CEP (COS) on PharmaCompass.
A GSK 685 698 written confirmation (GSK 685 698 WC) is an official document issued by a regulatory agency to a GSK 685 698 manufacturer, verifying that the manufacturing facility of a GSK 685 698 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting GSK 685 698 APIs or GSK 685 698 finished pharmaceutical products to another nation, regulatory agencies frequently require a GSK 685 698 WC (written confirmation) as part of the regulatory process.
click here to find a list of GSK 685 698 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 GSK 685 698 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for GSK 685 698 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 GSK 685 698 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 GSK 685 698 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a GSK 685 698 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of GSK 685 698 suppliers with NDC on PharmaCompass.
GSK 685 698 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 GSK 685 698 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 GSK 685 698 GMP manufacturer or GSK 685 698 GMP API supplier for your needs.
A GSK 685 698 CoA (Certificate of Analysis) is a formal document that attests to GSK 685 698's compliance with GSK 685 698 specifications and serves as a tool for batch-level quality control.
GSK 685 698 CoA mostly includes findings from lab analyses of a specific batch. For each GSK 685 698 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.
GSK 685 698 may be tested according to a variety of international standards, such as European Pharmacopoeia (GSK 685 698 EP), GSK 685 698 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (GSK 685 698 USP).
