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