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USDMF
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2025-01-24
Pay. Date : 2024-12-24
DMF Number : 39333
Submission : 2023-12-30
Status :
Type : II
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PharmaCompass offers a list of Viloxazine Hydrochloride 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 Viloxazine Hydrochloride manufacturer or Viloxazine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Viloxazine Hydrochloride manufacturer or Viloxazine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Viloxazine Hydrochloride API Price utilized in the formulation of products. Viloxazine Hydrochloride API Price is not always fixed or binding as the Viloxazine Hydrochloride Price is obtained through a variety of data sources. The Viloxazine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Viloxazine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Viloxazine Hydrochloride, including repackagers and relabelers. The FDA regulates Viloxazine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Viloxazine 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 Viloxazine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Viloxazine Hydrochloride supplier is an individual or a company that provides Viloxazine Hydrochloride active pharmaceutical ingredient (API) or Viloxazine Hydrochloride finished formulations upon request. The Viloxazine Hydrochloride suppliers may include Viloxazine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Viloxazine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Viloxazine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Viloxazine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Viloxazine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Viloxazine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Viloxazine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Viloxazine Hydrochloride USDMF includes data on Viloxazine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Viloxazine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Viloxazine Hydrochloride 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 Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Viloxazine 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 Viloxazine 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 Viloxazine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Viloxazine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Viloxazine Hydrochloride suppliers with NDC on PharmaCompass.
Viloxazine 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 Viloxazine 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 Viloxazine Hydrochloride GMP manufacturer or Viloxazine Hydrochloride GMP API supplier for your needs.
A Viloxazine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Viloxazine Hydrochloride's compliance with Viloxazine Hydrochloride specifications and serves as a tool for batch-level quality control.
Viloxazine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Viloxazine 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.
Viloxazine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Viloxazine Hydrochloride EP), Viloxazine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Viloxazine Hydrochloride USP).
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