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