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API SUPPLIERS
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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
Siegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7333
Submission : 1988-02-08
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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Laboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.
About the Company : Laboratorium Ofichem is a GMP-certified and FDA-approved API manufacturer with state-of-the-art development and production facilities in the Netherlands. We develop and manufacture...
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
About the Company : Nuray Chemicals Pvt Ltd, established in 2012 near Chennai, is an API manufacturer for highly regulated markets. Its state-of-the-art R&D facility specializes in synthesizing NCEs, ...
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
About the Company : Since 1962, MOEHS has produced high-quality Active Pharmaceutical Ingredients (APIs) for the global market. With decades of technical expertise, Moehs Group delivers pharmaceutical...
Siegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.
About the Company : Siegfried is a global Contract Development and Manufacturing Organization providing integrated services for pharmaceutical ingredients & finished dosage forms. With 13 production s...
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Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Methenamine Hippurate Orion
Dosage Form : Tablet
Dosage Strength : 1g
Packaging :
Approval Date : 30-10-2023
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden
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Regulatory Info :
Registration Country : Australia
Brand Name : Uramet
Dosage Form :
Dosage Strength :
Packaging : 100
Approval Date :
Application Number :
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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ABOUT THIS PAGE
27
PharmaCompass offers a list of Methenamine Hippurate 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 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.
A hexamine hippurate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of hexamine hippurate, including repackagers and relabelers. The FDA regulates hexamine hippurate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. hexamine 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 hexamine hippurate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A hexamine hippurate supplier is an individual or a company that provides hexamine hippurate active pharmaceutical ingredient (API) or hexamine hippurate finished formulations upon request. The hexamine hippurate suppliers may include hexamine hippurate API manufacturers, exporters, distributors and traders.
click here to find a list of hexamine hippurate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A hexamine hippurate DMF (Drug Master File) is a document detailing the whole manufacturing process of hexamine hippurate active pharmaceutical ingredient (API) in detail. Different forms of hexamine hippurate DMFs exist exist since differing nations have different regulations, such as hexamine hippurate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A hexamine hippurate DMF submitted to regulatory agencies in the US is known as a USDMF. hexamine hippurate USDMF includes data on hexamine hippurate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The hexamine hippurate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of hexamine hippurate suppliers with USDMF on PharmaCompass.
A hexamine hippurate written confirmation (hexamine hippurate WC) is an official document issued by a regulatory agency to a hexamine hippurate manufacturer, verifying that the manufacturing facility of a hexamine hippurate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting hexamine hippurate APIs or hexamine hippurate finished pharmaceutical products to another nation, regulatory agencies frequently require a hexamine hippurate WC (written confirmation) as part of the regulatory process.
click here to find a list of hexamine 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 hexamine hippurate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for hexamine 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 hexamine 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 hexamine hippurate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a hexamine hippurate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of hexamine hippurate suppliers with NDC on PharmaCompass.
hexamine 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 hexamine hippurate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right hexamine hippurate GMP manufacturer or hexamine hippurate GMP API supplier for your needs.
A hexamine hippurate CoA (Certificate of Analysis) is a formal document that attests to hexamine hippurate's compliance with hexamine hippurate specifications and serves as a tool for batch-level quality control.
hexamine hippurate CoA mostly includes findings from lab analyses of a specific batch. For each hexamine 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.
hexamine hippurate may be tested according to a variety of international standards, such as European Pharmacopoeia (hexamine hippurate EP), hexamine hippurate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (hexamine hippurate USP).
