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