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ABOUT THIS PAGE
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PharmaCompass offers a list of Methenamine Hippurate 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 Methenamine Hippurate manufacturer or Methenamine Hippurate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Methenamine Hippurate manufacturer or Methenamine Hippurate supplier.
PharmaCompass also assists you with knowing the Methenamine Hippurate API Price utilized in the formulation of products. Methenamine Hippurate API Price is not always fixed or binding as the Methenamine Hippurate Price is obtained through a variety of data sources. The Methenamine Hippurate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Hip-Rex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hip-Rex, including repackagers and relabelers. The FDA regulates Hip-Rex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hip-Rex 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 Hip-Rex manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hip-Rex supplier is an individual or a company that provides Hip-Rex active pharmaceutical ingredient (API) or Hip-Rex finished formulations upon request. The Hip-Rex suppliers may include Hip-Rex API manufacturers, exporters, distributors and traders.
click here to find a list of Hip-Rex suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Hip-Rex DMF (Drug Master File) is a document detailing the whole manufacturing process of Hip-Rex active pharmaceutical ingredient (API) in detail. Different forms of Hip-Rex DMFs exist exist since differing nations have different regulations, such as Hip-Rex USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hip-Rex DMF submitted to regulatory agencies in the US is known as a USDMF. Hip-Rex USDMF includes data on Hip-Rex's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hip-Rex USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hip-Rex suppliers with USDMF on PharmaCompass.
A Hip-Rex written confirmation (Hip-Rex WC) is an official document issued by a regulatory agency to a Hip-Rex manufacturer, verifying that the manufacturing facility of a Hip-Rex active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Hip-Rex APIs or Hip-Rex finished pharmaceutical products to another nation, regulatory agencies frequently require a Hip-Rex WC (written confirmation) as part of the regulatory process.
click here to find a list of Hip-Rex 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 Hip-Rex as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Hip-Rex 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 Hip-Rex 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 Hip-Rex and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Hip-Rex NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Hip-Rex suppliers with NDC on PharmaCompass.
Hip-Rex 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 Hip-Rex 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 Hip-Rex GMP manufacturer or Hip-Rex GMP API supplier for your needs.
A Hip-Rex CoA (Certificate of Analysis) is a formal document that attests to Hip-Rex's compliance with Hip-Rex specifications and serves as a tool for batch-level quality control.
Hip-Rex CoA mostly includes findings from lab analyses of a specific batch. For each Hip-Rex 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.
Hip-Rex may be tested according to a variety of international standards, such as European Pharmacopoeia (Hip-Rex EP), Hip-Rex JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Hip-Rex USP).
