Synopsis
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CEP/COS
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JDMF
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KDMF
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VMF
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Canada
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Listed Dossiers
DRUG PRODUCT COMPOSITIONS
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Data Compilation #PharmaFlow
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API SUPPLIERS
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
Mesochem is focused on incessant innovation along with the R&D of new APIs.
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USDMF
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Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
About the Company : Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in th...
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
About the Company : Omgene Life Sciences Private Limited is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically...
Mesochem is focused on incessant innovation along with the R&D of new APIs.
About the Company : Beijing Mesochem Technology Co. Ltd., which is located in the national economic and technological development area of Yizhuang, China, manufactures pharmaceutical chemicals, fine c...
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API Imports and Exports
Drugs in Development
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DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
1 Acetyl Naphthalene (1 Acetonaphthone)
CAS Number : 941-98-0
End Use API : Bedaquiline
About The Company : DKSH, founded with the goal of improving people's lives, assists businesses with market expansion and business growth in both existing and emerging markets. It ...
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SPI Pharma
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Taste Masking
Excipient Details : CS90 is a directly compressible calcium carbonate with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 150-175 µm, Tapped Density: 0.85
Ingredient(s) : Calcium Carbonate Excipient
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Taste Masking
Excipient Details : MS90 is a directly compressible magnesium hydroxide with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 150-170 µm, Tapped Density: 0.80
Ingredient(s) : Magnesium Hydroxide Excipient
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
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Direct Compression
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Granulation
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Co-Processed Excipients
Taste Masking
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Solubilizers
Emulsifying Agents
Controlled & Modified Release
Coating Systems & Additives
Parenteral
Surfactant & Foaming Agents
Topical
Rheology Modifiers
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API Stability Enhancers
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
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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.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Bedaquiline manufacturer or Bedaquiline supplier.
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 (fumarate) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bedaquiline (fumarate), including repackagers and relabelers. The FDA regulates Bedaquiline (fumarate) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bedaquiline (fumarate) 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 (fumarate) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bedaquiline (fumarate) supplier is an individual or a company that provides Bedaquiline (fumarate) active pharmaceutical ingredient (API) or Bedaquiline (fumarate) finished formulations upon request. The Bedaquiline (fumarate) suppliers may include Bedaquiline (fumarate) API manufacturers, exporters, distributors and traders.
click here to find a list of Bedaquiline (fumarate) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bedaquiline (fumarate) DMF (Drug Master File) is a document detailing the whole manufacturing process of Bedaquiline (fumarate) active pharmaceutical ingredient (API) in detail. Different forms of Bedaquiline (fumarate) DMFs exist exist since differing nations have different regulations, such as Bedaquiline (fumarate) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bedaquiline (fumarate) DMF submitted to regulatory agencies in the US is known as a USDMF. Bedaquiline (fumarate) USDMF includes data on Bedaquiline (fumarate)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bedaquiline (fumarate) USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bedaquiline (fumarate) suppliers with USDMF on PharmaCompass.
A Bedaquiline (fumarate) written confirmation (Bedaquiline (fumarate) WC) is an official document issued by a regulatory agency to a Bedaquiline (fumarate) manufacturer, verifying that the manufacturing facility of a Bedaquiline (fumarate) active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Bedaquiline (fumarate) APIs or Bedaquiline (fumarate) finished pharmaceutical products to another nation, regulatory agencies frequently require a Bedaquiline (fumarate) WC (written confirmation) as part of the regulatory process.
click here to find a list of Bedaquiline (fumarate) 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 (fumarate) as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Bedaquiline (fumarate) 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 (fumarate) 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 (fumarate) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Bedaquiline (fumarate) NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Bedaquiline (fumarate) suppliers with NDC on PharmaCompass.
Bedaquiline (fumarate) 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 (fumarate) 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 (fumarate) GMP manufacturer or Bedaquiline (fumarate) GMP API supplier for your needs.
A Bedaquiline (fumarate) CoA (Certificate of Analysis) is a formal document that attests to Bedaquiline (fumarate)'s compliance with Bedaquiline (fumarate) specifications and serves as a tool for batch-level quality control.
Bedaquiline (fumarate) CoA mostly includes findings from lab analyses of a specific batch. For each Bedaquiline (fumarate) 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 (fumarate) may be tested according to a variety of international standards, such as European Pharmacopoeia (Bedaquiline (fumarate) EP), Bedaquiline (fumarate) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bedaquiline (fumarate) USP).
