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DRUG PRODUCT COMPOSITIONS
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Data Compilation #PharmaFlow
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API SUPPLIERS
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USDMF
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Withdrawn
Registration Country : Malta
Brand Name : Rhinathiol Sugar-Free
Dosage Form : Syrup
Dosage Strength : 20MG/ML
Packaging :
Approval Date : 2006-11-15
Application Number :
Regulatory Info : Withdrawn
Registration Country : Malta
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Withdrawn
Registration Country : Malta
Brand Name : Rhinathiol
Dosage Form : Syrup
Dosage Strength : 20MG/ML
Packaging :
Approval Date : 2006-12-12
Application Number :
Regulatory Info : Withdrawn
Registration Country : Malta
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Withdrawn
Registration Country : Malta
Brand Name : Rhinathiol
Dosage Form : Syrup
Dosage Strength : 100ML
Packaging :
Approval Date : 2006-12-12
Application Number :
Regulatory Info : Withdrawn
Registration Country : Malta
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Withdrawn
Registration Country : Malta
Brand Name : Rhinathiol Sugar-Free
Dosage Form : Syrup
Dosage Strength : 50MG/ML
Packaging :
Approval Date : 2006-11-15
Application Number :
Regulatory Info : Withdrawn
Registration Country : Malta
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Withdrawn
Registration Country : Malta
Carbocisteine; Promethazine Hydrochloride
Brand Name : Rhinathiol Promethazine
Dosage Form : Syrup
Dosage Strength : 100ML; 100ML
Packaging :
Approval Date : 2006-12-12
Application Number :
Regulatory Info : Withdrawn
Registration Country : Malta
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Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Dis-Chem Mucolytic
Dosage Form : SYR
Dosage Strength : 250mg/5ml
Packaging : 200X1mg/5ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Bronchette
Dosage Form : SYR
Dosage Strength : 250mg/5ml
Packaging : 200X1mg/5ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Flusin Mucous Cough
Dosage Form : SYR
Dosage Strength : 250mg/5 ml
Packaging : 200X1mg/5 ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Flutex Mucous Cough
Dosage Form : SYR
Dosage Strength : 250mg/5ml
Packaging : 200X1mg/5ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Mucospect
Dosage Form : SYR
Dosage Strength : 250mg/5ml
Packaging : 200X1mg/5ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Mucospect
Dosage Form : CAP
Dosage Strength : 375mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Co-flem
Dosage Form : SYR
Dosage Strength : 250mg/5ml
Packaging : 200X1mg/5ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Mucospect Paed
Dosage Form : SYR
Dosage Strength : 125mg/5ml
Packaging : 100X1mg/5ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Flemlite
Dosage Form : SYR
Dosage Strength : 250mg/5ml
Packaging : 200X1mg/5ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
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REF. STANDARDS & IMPURITIES
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
33
PharmaCompass offers a list of Carbocisteine 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 Carbocisteine manufacturer or Carbocisteine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Carbocisteine manufacturer or Carbocisteine supplier.
A carbocistein manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of carbocistein, including repackagers and relabelers. The FDA regulates carbocistein manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. carbocistein 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 carbocistein manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A carbocistein supplier is an individual or a company that provides carbocistein active pharmaceutical ingredient (API) or carbocistein finished formulations upon request. The carbocistein suppliers may include carbocistein API manufacturers, exporters, distributors and traders.
click here to find a list of carbocistein suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A carbocistein DMF (Drug Master File) is a document detailing the whole manufacturing process of carbocistein active pharmaceutical ingredient (API) in detail. Different forms of carbocistein DMFs exist exist since differing nations have different regulations, such as carbocistein USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A carbocistein DMF submitted to regulatory agencies in the US is known as a USDMF. carbocistein USDMF includes data on carbocistein's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The carbocistein USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of carbocistein suppliers with USDMF on PharmaCompass.
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 carbocistein Drug Master File in Japan (carbocistein JDMF) empowers carbocistein 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 carbocistein JDMF during the approval evaluation for pharmaceutical products. At the time of carbocistein JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of carbocistein suppliers with JDMF on PharmaCompass.
A carbocistein CEP of the European Pharmacopoeia monograph is often referred to as a carbocistein Certificate of Suitability (COS). The purpose of a carbocistein CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of carbocistein EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of carbocistein to their clients by showing that a carbocistein CEP has been issued for it. The manufacturer submits a carbocistein CEP (COS) as part of the market authorization procedure, and it takes on the role of a carbocistein CEP holder for the record. Additionally, the data presented in the carbocistein CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the carbocistein DMF.
A carbocistein CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. carbocistein CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of carbocistein suppliers with CEP (COS) 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 carbocistein as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for carbocistein 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 carbocistein 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 carbocistein and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a carbocistein NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of carbocistein suppliers with NDC on PharmaCompass.
carbocistein 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 carbocistein GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right carbocistein GMP manufacturer or carbocistein GMP API supplier for your needs.
A carbocistein CoA (Certificate of Analysis) is a formal document that attests to carbocistein's compliance with carbocistein specifications and serves as a tool for batch-level quality control.
carbocistein CoA mostly includes findings from lab analyses of a specific batch. For each carbocistein 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.
carbocistein may be tested according to a variety of international standards, such as European Pharmacopoeia (carbocistein EP), carbocistein JP (Japanese Pharmacopeia) and the US Pharmacopoeia (carbocistein USP).
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