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API SUPPLIERS
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
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NDC
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
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FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
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Regulatory Info :
Registration Country : Australia
Brand Name : Uramet
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Packaging : 100
Approval Date :
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Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Uramet
Dosage Form :
Dosage Strength :
Packaging : 100
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Methenamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Methenamine, including repackagers and relabelers. The FDA regulates Methenamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Methenamine 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Methenamine supplier is an individual or a company that provides Methenamine active pharmaceutical ingredient (API) or Methenamine finished formulations upon request. The Methenamine suppliers may include Methenamine API manufacturers, exporters, distributors and traders.
click here to find a list of Methenamine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Methenamine DMF (Drug Master File) is a document detailing the whole manufacturing process of Methenamine active pharmaceutical ingredient (API) in detail. Different forms of Methenamine DMFs exist exist since differing nations have different regulations, such as Methenamine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Methenamine DMF submitted to regulatory agencies in the US is known as a USDMF. Methenamine USDMF includes data on Methenamine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Methenamine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Methenamine suppliers with USDMF on PharmaCompass.
A Methenamine written confirmation (Methenamine WC) is an official document issued by a regulatory agency to a Methenamine manufacturer, verifying that the manufacturing facility of a Methenamine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Methenamine APIs or Methenamine finished pharmaceutical products to another nation, regulatory agencies frequently require a Methenamine WC (written confirmation) as part of the regulatory process.
click here to find a list of Methenamine 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 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Methenamine 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Methenamine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Methenamine suppliers with NDC on PharmaCompass.
Methenamine 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 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 GMP manufacturer or Methenamine GMP API supplier for your needs.
A Methenamine CoA (Certificate of Analysis) is a formal document that attests to Methenamine's compliance with Methenamine specifications and serves as a tool for batch-level quality control.
Methenamine CoA mostly includes findings from lab analyses of a specific batch. For each Methenamine 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Methenamine EP), Methenamine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Methenamine USP).
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