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JDMF
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Europe
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API SUPPLIERS
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
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USDMF
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39333
Submission : 2023-12-30
Status :
Type : II
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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
About the Company : Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs ...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product ...
Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
About the Company : Macsen is a USFDA registered, TGA GMP & WHO-GMP certified manufacturer and supplier of Active Pharmaceutical Ingredients (APIs), Biological Stains & Specialty Fine Chemicals. Our c...
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API Imports and Exports
Drugs in Development
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Viloxazine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Viloxazine, including repackagers and relabelers. The FDA regulates Viloxazine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Viloxazine 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 Viloxazine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Viloxazine supplier is an individual or a company that provides Viloxazine active pharmaceutical ingredient (API) or Viloxazine finished formulations upon request. The Viloxazine suppliers may include Viloxazine API manufacturers, exporters, distributors and traders.
click here to find a list of Viloxazine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Viloxazine DMF (Drug Master File) is a document detailing the whole manufacturing process of Viloxazine active pharmaceutical ingredient (API) in detail. Different forms of Viloxazine DMFs exist exist since differing nations have different regulations, such as Viloxazine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Viloxazine DMF submitted to regulatory agencies in the US is known as a USDMF. Viloxazine USDMF includes data on Viloxazine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Viloxazine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Viloxazine suppliers with USDMF 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 Viloxazine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Viloxazine 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 Viloxazine 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 Viloxazine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Viloxazine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Viloxazine suppliers with NDC on PharmaCompass.
Viloxazine 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 Viloxazine 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 Viloxazine GMP manufacturer or Viloxazine GMP API supplier for your needs.
A Viloxazine CoA (Certificate of Analysis) is a formal document that attests to Viloxazine's compliance with Viloxazine specifications and serves as a tool for batch-level quality control.
Viloxazine CoA mostly includes findings from lab analyses of a specific batch. For each Viloxazine 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.
Viloxazine may be tested according to a variety of international standards, such as European Pharmacopoeia (Viloxazine EP), Viloxazine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Viloxazine USP).
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