US DMFs Filed
USA (Orange Book)
PharmaCompass offers a list of Benazepril Hydrochloride 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 Benazepril Hydrochloride manufacturer or Benazepril Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Benazepril Hydrochloride manufacturer or Benazepril Hydrochloride supplier.
PharmaCompass also assists you with knowing the Benazepril Hydrochloride API Price utilized in the formulation of products. Benazepril Hydrochloride API Price is not always fixed or binding as the Benazepril Hydrochloride Price is obtained through a variety of data sources. The Benazepril Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Benazepril Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Benazepril Hydrochloride, including repackagers and relabelers. The FDA regulates Benazepril Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Benazepril Hydrochloride 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 Benazepril Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Benazepril Hydrochloride supplier is an individual or a company that provides Benazepril Hydrochloride active pharmaceutical ingredient (API) or Benazepril Hydrochloride finished formulations upon request. The Benazepril Hydrochloride suppliers may include Benazepril Hydrochloride API manufacturers, exporters, distributors and traders.
CLICK HERE to find a list of Benazepril Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Benazepril Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Benazepril Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Benazepril Hydrochloride DMFs exist exist since differing nations have different regulations, such as Benazepril Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Benazepril Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Benazepril Hydrochloride USDMF includes data on Benazepril Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Benazepril Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 Benazepril Hydrochloride Drug Master File in Japan (Benazepril Hydrochloride JDMF) empowers Benazepril Hydrochloride 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 Benazepril Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Benazepril Hydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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A Benazepril Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Benazepril Hydrochloride Certificate of Suitability (COS). The purpose of a Benazepril Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Benazepril Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Benazepril Hydrochloride to their clients by showing that a Benazepril Hydrochloride CEP has been issued for it. The manufacturer submits a Benazepril Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Benazepril Hydrochloride CEP holder for the record. Additionally, the data presented in the Benazepril Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Benazepril Hydrochloride DMF.
A Benazepril Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Benazepril Hydrochloride CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A Benazepril Hydrochloride written confirmation (Benazepril Hydrochloride WC) is an official document issued by a regulatory agency to a Benazepril Hydrochloride manufacturer, verifying that the manufacturing facility of a Benazepril Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Benazepril Hydrochloride APIs or Benazepril Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Benazepril Hydrochloride WC (written confirmation) as part of the regulatory process.
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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 Benazepril Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Benazepril Hydrochloride 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 Benazepril Hydrochloride 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 Benazepril Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Benazepril Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
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Benazepril Hydrochloride 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 Benazepril Hydrochloride 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 Benazepril Hydrochloride GMP manufacturer or Benazepril Hydrochloride GMP API supplier for your needs.
A Benazepril Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Benazepril Hydrochloride's compliance with Benazepril Hydrochloride specifications and serves as a tool for batch-level quality control.
Benazepril Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Benazepril Hydrochloride 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.
Benazepril Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Benazepril Hydrochloride EP), Benazepril Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Benazepril Hydrochloride USP).