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NDC API
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EDQM
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USP
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JP
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FDF Dossiers
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FDA Orange Book
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Europe
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Data Compilation #PharmaFlow
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ABOUT THIS PAGE
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PharmaCompass offers a list of Benzamidine 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 Benzamidine manufacturer or Benzamidine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Benzamidine manufacturer or Benzamidine supplier.
PharmaCompass also assists you with knowing the Benzamidine API Price utilized in the formulation of products. Benzamidine API Price is not always fixed or binding as the Benzamidine Price is obtained through a variety of data sources. The Benzamidine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Benzamidine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Benzamidine, including repackagers and relabelers. The FDA regulates Benzamidine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Benzamidine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Benzamidine supplier is an individual or a company that provides Benzamidine active pharmaceutical ingredient (API) or Benzamidine finished formulations upon request. The Benzamidine suppliers may include Benzamidine API manufacturers, exporters, distributors and traders.
click here to find a list of Benzamidine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Benzamidine DMF (Drug Master File) is a document detailing the whole manufacturing process of Benzamidine active pharmaceutical ingredient (API) in detail. Different forms of Benzamidine DMFs exist exist since differing nations have different regulations, such as Benzamidine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Benzamidine DMF submitted to regulatory agencies in the US is known as a USDMF. Benzamidine USDMF includes data on Benzamidine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Benzamidine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Benzamidine suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Benzamidine Drug Master File in Japan (Benzamidine JDMF) empowers Benzamidine API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Benzamidine JDMF during the approval evaluation for pharmaceutical products. At the time of Benzamidine JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Benzamidine suppliers with JDMF on PharmaCompass.
Benzamidine 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 Benzamidine 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 Benzamidine GMP manufacturer or Benzamidine GMP API supplier for your needs.
A Benzamidine CoA (Certificate of Analysis) is a formal document that attests to Benzamidine's compliance with Benzamidine specifications and serves as a tool for batch-level quality control.
Benzamidine CoA mostly includes findings from lab analyses of a specific batch. For each Benzamidine 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.
Benzamidine may be tested according to a variety of international standards, such as European Pharmacopoeia (Benzamidine EP), Benzamidine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Benzamidine USP).
