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USDMF
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DOSAGE - TABLET;ORAL - 400MG
USFDA APPLICATION NUMBER - 21179
DOSAGE - TABLET;ORAL - 800MG
USFDA APPLICATION NUMBER - 21179
Related Excipient Companies
Nanjing Well Pharmaceutical
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ABOUT THIS PAGE
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PharmaCompass offers a list of Sevelamer Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Sevelamer Hydrochloride manufacturer or Sevelamer Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sevelamer Hydrochloride manufacturer or Sevelamer Hydrochloride supplier.
A RenaGel manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of RenaGel, including repackagers and relabelers. The FDA regulates RenaGel manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. RenaGel 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 RenaGel manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A RenaGel supplier is an individual or a company that provides RenaGel active pharmaceutical ingredient (API) or RenaGel finished formulations upon request. The RenaGel suppliers may include RenaGel API manufacturers, exporters, distributors and traders.
click here to find a list of RenaGel suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A RenaGel DMF (Drug Master File) is a document detailing the whole manufacturing process of RenaGel active pharmaceutical ingredient (API) in detail. Different forms of RenaGel DMFs exist exist since differing nations have different regulations, such as RenaGel USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A RenaGel DMF submitted to regulatory agencies in the US is known as a USDMF. RenaGel USDMF includes data on RenaGel's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The RenaGel USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of RenaGel 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 RenaGel Drug Master File in Japan (RenaGel JDMF) empowers RenaGel 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 RenaGel JDMF during the approval evaluation for pharmaceutical products. At the time of RenaGel 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 RenaGel suppliers with JDMF on PharmaCompass.
A RenaGel written confirmation (RenaGel WC) is an official document issued by a regulatory agency to a RenaGel manufacturer, verifying that the manufacturing facility of a RenaGel active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting RenaGel APIs or RenaGel finished pharmaceutical products to another nation, regulatory agencies frequently require a RenaGel WC (written confirmation) as part of the regulatory process.
click here to find a list of RenaGel 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 RenaGel as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for RenaGel 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 RenaGel 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 RenaGel and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a RenaGel NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of RenaGel suppliers with NDC on PharmaCompass.
RenaGel 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 RenaGel GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right RenaGel GMP manufacturer or RenaGel GMP API supplier for your needs.
A RenaGel CoA (Certificate of Analysis) is a formal document that attests to RenaGel's compliance with RenaGel specifications and serves as a tool for batch-level quality control.
RenaGel CoA mostly includes findings from lab analyses of a specific batch. For each RenaGel 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.
RenaGel may be tested according to a variety of international standards, such as European Pharmacopoeia (RenaGel EP), RenaGel JP (Japanese Pharmacopeia) and the US Pharmacopoeia (RenaGel USP).
