API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
Other Certificates
Other Suppliers
0
USA (Orange Book)
Europe
0
Canada
Australia
0
South Africa
0
Uploaded Dossiers
U.S. Medicaid
Annual Reports
0
89
PharmaCompass offers a list of Fluphenazine Deconate 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 Fluphenazine Deconate manufacturer or Fluphenazine Deconate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Fluphenazine Deconate manufacturer or Fluphenazine Deconate supplier.
PharmaCompass also assists you with knowing the Fluphenazine Deconate API Price utilized in the formulation of products. Fluphenazine Deconate API Price is not always fixed or binding as the Fluphenazine Deconate Price is obtained through a variety of data sources. The Fluphenazine Deconate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Fluphenazine Decanoate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fluphenazine Decanoate, including repackagers and relabelers. The FDA regulates Fluphenazine Decanoate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fluphenazine Decanoate 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 Fluphenazine Decanoate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fluphenazine Decanoate supplier is an individual or a company that provides Fluphenazine Decanoate active pharmaceutical ingredient (API) or Fluphenazine Decanoate finished formulations upon request. The Fluphenazine Decanoate suppliers may include Fluphenazine Decanoate API manufacturers, exporters, distributors and traders.
click here to find a list of Fluphenazine Decanoate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fluphenazine Decanoate DMF (Drug Master File) is a document detailing the whole manufacturing process of Fluphenazine Decanoate active pharmaceutical ingredient (API) in detail. Different forms of Fluphenazine Decanoate DMFs exist exist since differing nations have different regulations, such as Fluphenazine Decanoate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fluphenazine Decanoate DMF submitted to regulatory agencies in the US is known as a USDMF. Fluphenazine Decanoate USDMF includes data on Fluphenazine Decanoate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fluphenazine Decanoate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fluphenazine Decanoate 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 Fluphenazine Decanoate Drug Master File in Japan (Fluphenazine Decanoate JDMF) empowers Fluphenazine Decanoate 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 Fluphenazine Decanoate JDMF during the approval evaluation for pharmaceutical products. At the time of Fluphenazine Decanoate 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 Fluphenazine Decanoate suppliers with JDMF on PharmaCompass.
A Fluphenazine Decanoate CEP of the European Pharmacopoeia monograph is often referred to as a Fluphenazine Decanoate Certificate of Suitability (COS). The purpose of a Fluphenazine Decanoate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Fluphenazine Decanoate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Fluphenazine Decanoate to their clients by showing that a Fluphenazine Decanoate CEP has been issued for it. The manufacturer submits a Fluphenazine Decanoate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Fluphenazine Decanoate CEP holder for the record. Additionally, the data presented in the Fluphenazine Decanoate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Fluphenazine Decanoate DMF.
A Fluphenazine Decanoate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Fluphenazine Decanoate 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 Fluphenazine Decanoate suppliers with CEP (COS) on PharmaCompass.
A Fluphenazine Decanoate written confirmation (Fluphenazine Decanoate WC) is an official document issued by a regulatory agency to a Fluphenazine Decanoate manufacturer, verifying that the manufacturing facility of a Fluphenazine Decanoate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Fluphenazine Decanoate APIs or Fluphenazine Decanoate finished pharmaceutical products to another nation, regulatory agencies frequently require a Fluphenazine Decanoate WC (written confirmation) as part of the regulatory process.
click here to find a list of Fluphenazine Decanoate 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 Fluphenazine Decanoate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Fluphenazine Decanoate 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 Fluphenazine Decanoate 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 Fluphenazine Decanoate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fluphenazine Decanoate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Fluphenazine Decanoate suppliers with NDC on PharmaCompass.
Fluphenazine Decanoate 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 Fluphenazine Decanoate 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 Fluphenazine Decanoate GMP manufacturer or Fluphenazine Decanoate GMP API supplier for your needs.
A Fluphenazine Decanoate CoA (Certificate of Analysis) is a formal document that attests to Fluphenazine Decanoate's compliance with Fluphenazine Decanoate specifications and serves as a tool for batch-level quality control.
Fluphenazine Decanoate CoA mostly includes findings from lab analyses of a specific batch. For each Fluphenazine Decanoate 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.
Fluphenazine Decanoate may be tested according to a variety of international standards, such as European Pharmacopoeia (Fluphenazine Decanoate EP), Fluphenazine Decanoate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fluphenazine Decanoate USP).