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