Synopsis
0
CEP/COS
0
JDMF
0
KDMF
0
VMF
0
Canada
0
Australia
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kirsch Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Dr. Paul Lohmann GmbH & Co. KGaA
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]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gloria Interchem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Keval Exports
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Neelkanth MineChem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nitika Pharmaceutical Specialities
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Direct Compression
Disintegrants & Superdisintegrants
Granulation
Thickeners and Stabilizers
Co-Processed Excipients
Lubricants & Glidants
Chewable & Orodispersible Aids
Taste Masking
Solubilizers
Emulsifying Agents
Parenteral
Surfactant & Foaming Agents
Controlled & Modified Release
Topical
Rheology Modifiers
Coating Systems & Additives
Film Formers & Plasticizers
API Stability Enhancers
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Regulatory FDF Prices
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
APIs
Reply
01 Dec 2025
Reply
29 Aug 2024
Reply
15 Dec 2020
Reply
26 Oct 2020
Reply
08 Jul 2019
Reply
15 Sep 2018
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
US Patents
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
14
PharmaCompass offers a list of Bedaquiline API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Bedaquiline manufacturer or Bedaquiline supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Bedaquiline manufacturer or Bedaquiline supplier.
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.
click here to find a list of Bedaquiline manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
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, and COA 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.
click here to find a list of Bedaquiline suppliers with USDMF on PharmaCompass.
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.
click here to find a list of Bedaquiline 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 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.
click here to find a list of Bedaquiline suppliers with NDC on PharmaCompass.
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, 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).
Comment (3)
