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