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API SUPPLIERS
Laboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
NDC 
NDC
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
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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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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
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 : Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in th...
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
About the Company : Since its founding in 1962, MOEHS has produced Active Pharmaceutical Ingredients (APIs) for the international pharmaceutical industry. Thanks to a business history of more than 50 ...
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Rochem International Inc
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
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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 Haiprex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Haiprex, including repackagers and relabelers. The FDA regulates Haiprex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Haiprex 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 Haiprex manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Haiprex supplier is an individual or a company that provides Haiprex active pharmaceutical ingredient (API) or Haiprex finished formulations upon request. The Haiprex suppliers may include Haiprex API manufacturers, exporters, distributors and traders.
click here to find a list of Haiprex suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Haiprex DMF (Drug Master File) is a document detailing the whole manufacturing process of Haiprex active pharmaceutical ingredient (API) in detail. Different forms of Haiprex DMFs exist exist since differing nations have different regulations, such as Haiprex USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Haiprex DMF submitted to regulatory agencies in the US is known as a USDMF. Haiprex USDMF includes data on Haiprex's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Haiprex USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Haiprex suppliers with USDMF on PharmaCompass.
A Haiprex written confirmation (Haiprex WC) is an official document issued by a regulatory agency to a Haiprex manufacturer, verifying that the manufacturing facility of a Haiprex active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Haiprex APIs or Haiprex finished pharmaceutical products to another nation, regulatory agencies frequently require a Haiprex WC (written confirmation) as part of the regulatory process.
click here to find a list of Haiprex 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 Haiprex as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Haiprex 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 Haiprex 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 Haiprex and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Haiprex NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Haiprex suppliers with NDC on PharmaCompass.
Haiprex 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 Haiprex 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 Haiprex GMP manufacturer or Haiprex GMP API supplier for your needs.
A Haiprex CoA (Certificate of Analysis) is a formal document that attests to Haiprex's compliance with Haiprex specifications and serves as a tool for batch-level quality control.
Haiprex CoA mostly includes findings from lab analyses of a specific batch. For each Haiprex 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.
Haiprex may be tested according to a variety of international standards, such as European Pharmacopoeia (Haiprex EP), Haiprex JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Haiprex USP).
