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