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API SUPPLIERS
Century has been an API manufacturer for over 40 years & is the partner of choice for multipurpose custom manufacturing projects.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Aspen API. More than just an API™
ASMF
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USDMF
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Century has been an API manufacturer for over 40 years & is the partner of choice for multipurpose custom manufacturing projects.
About the Company : Century Pharmaceuticals, established in 1982, has 40 years of experience in manufacturing APIs. It has been supplying APIs produced in-house to several major pharma companies in In...
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...
Aspen API. More than just an API™
About the Company : Aspen API is the cooperative entity formed by Aspen Oss in the Netherlands and Fine Chemicals Corporation in South Africa. With quality, compliance, and teamwork at its core, Aspen...
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
Lead Product(s) : Fluphenazine
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The launch of Fluphenazine Hydrochloride Tablets, USP, a therapeutic equivalent generic version of Prolixin Tablets, 1 mg, 2.5 mg, 5 mg, and 10 mg, which is approved by the U.S. Food and Drug Administration (USFDA).
Product Name : Fluphenazine Hydrochloride-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 18, 2021
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EUROAPI
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Fluphenazine 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 manufacturer or Fluphenazine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Fluphenazine manufacturer or Fluphenazine supplier.
PharmaCompass also assists you with knowing the Fluphenazine API Price utilized in the formulation of products. Fluphenazine API Price is not always fixed or binding as the Fluphenazine Price is obtained through a variety of data sources. The Fluphenazine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Anatensol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Anatensol, including repackagers and relabelers. The FDA regulates Anatensol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Anatensol 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 Anatensol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Anatensol supplier is an individual or a company that provides Anatensol active pharmaceutical ingredient (API) or Anatensol finished formulations upon request. The Anatensol suppliers may include Anatensol API manufacturers, exporters, distributors and traders.
click here to find a list of Anatensol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Anatensol DMF (Drug Master File) is a document detailing the whole manufacturing process of Anatensol active pharmaceutical ingredient (API) in detail. Different forms of Anatensol DMFs exist exist since differing nations have different regulations, such as Anatensol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Anatensol DMF submitted to regulatory agencies in the US is known as a USDMF. Anatensol USDMF includes data on Anatensol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Anatensol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Anatensol suppliers with USDMF on PharmaCompass.
A Anatensol CEP of the European Pharmacopoeia monograph is often referred to as a Anatensol Certificate of Suitability (COS). The purpose of a Anatensol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Anatensol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Anatensol to their clients by showing that a Anatensol CEP has been issued for it. The manufacturer submits a Anatensol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Anatensol CEP holder for the record. Additionally, the data presented in the Anatensol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Anatensol DMF.
A Anatensol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Anatensol 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 Anatensol suppliers with CEP (COS) on PharmaCompass.
A Anatensol written confirmation (Anatensol WC) is an official document issued by a regulatory agency to a Anatensol manufacturer, verifying that the manufacturing facility of a Anatensol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Anatensol APIs or Anatensol finished pharmaceutical products to another nation, regulatory agencies frequently require a Anatensol WC (written confirmation) as part of the regulatory process.
click here to find a list of Anatensol 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 Anatensol as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Anatensol 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 Anatensol 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 Anatensol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Anatensol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Anatensol suppliers with NDC on PharmaCompass.
Anatensol 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 Anatensol 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 Anatensol GMP manufacturer or Anatensol GMP API supplier for your needs.
A Anatensol CoA (Certificate of Analysis) is a formal document that attests to Anatensol's compliance with Anatensol specifications and serves as a tool for batch-level quality control.
Anatensol CoA mostly includes findings from lab analyses of a specific batch. For each Anatensol 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.
Anatensol may be tested according to a variety of international standards, such as European Pharmacopoeia (Anatensol EP), Anatensol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Anatensol USP).
