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