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USDMF
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Complete
Rev. Date : 2024-07-23
Pay. Date : 2024-07-08
DMF Number : 40057
Submission : 2024-07-04
Status :
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-27
Pay. Date : 2014-03-28
DMF Number : 28120
Submission : 2014-04-04
Status :
Type : II
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REF. STANDARDS & IMPURITIES
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 Methenamine Hippurate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Methenamine Hippurate, including repackagers and relabelers. The FDA regulates Methenamine Hippurate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Methenamine Hippurate 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 Methenamine Hippurate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Methenamine Hippurate supplier is an individual or a company that provides Methenamine Hippurate active pharmaceutical ingredient (API) or Methenamine Hippurate finished formulations upon request. The Methenamine Hippurate suppliers may include Methenamine Hippurate API manufacturers, exporters, distributors and traders.
click here to find a list of Methenamine Hippurate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Methenamine Hippurate DMF (Drug Master File) is a document detailing the whole manufacturing process of Methenamine Hippurate active pharmaceutical ingredient (API) in detail. Different forms of Methenamine Hippurate DMFs exist exist since differing nations have different regulations, such as Methenamine Hippurate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Methenamine Hippurate DMF submitted to regulatory agencies in the US is known as a USDMF. Methenamine Hippurate USDMF includes data on Methenamine Hippurate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Methenamine Hippurate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Methenamine Hippurate suppliers with USDMF on PharmaCompass.
A Methenamine Hippurate written confirmation (Methenamine Hippurate WC) is an official document issued by a regulatory agency to a Methenamine Hippurate manufacturer, verifying that the manufacturing facility of a Methenamine Hippurate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Methenamine Hippurate APIs or Methenamine Hippurate finished pharmaceutical products to another nation, regulatory agencies frequently require a Methenamine Hippurate WC (written confirmation) as part of the regulatory process.
click here to find a list of Methenamine Hippurate 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 Methenamine Hippurate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Methenamine Hippurate 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 Methenamine Hippurate 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 Methenamine Hippurate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Methenamine Hippurate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Methenamine Hippurate suppliers with NDC on PharmaCompass.
Methenamine Hippurate 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 Methenamine Hippurate 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 Methenamine Hippurate GMP manufacturer or Methenamine Hippurate GMP API supplier for your needs.
A Methenamine Hippurate CoA (Certificate of Analysis) is a formal document that attests to Methenamine Hippurate's compliance with Methenamine Hippurate specifications and serves as a tool for batch-level quality control.
Methenamine Hippurate CoA mostly includes findings from lab analyses of a specific batch. For each Methenamine Hippurate 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.
Methenamine Hippurate may be tested according to a variety of international standards, such as European Pharmacopoeia (Methenamine Hippurate EP), Methenamine Hippurate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Methenamine Hippurate USP).
