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API SUPPLIERS
Axplora- The partner of choice for complex APIs.
JDMF
EU-WC
NDC
Basic Nutrition, your expert for sourcing from China, India and Europe.
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
JDMF
ASMF 
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
Axplora- The partner of choice for complex APIs.
NDC
Axplora- The partner of choice for complex APIs.
NDC
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
ASMF
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
ASMF
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USDMF
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Axplora- The partner of choice for complex APIs.
Certificate Number : R1-CEP 1998-038 - Rev 05
Status : Valid
Issue Date : 2017-05-19
Type : Chemical
Substance Number : 885
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
Certificate Number : R1-CEP 1997-037 - Rev 06
Status : Valid
Issue Date : 2019-04-16
Type : Chemical
Substance Number : 885
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API Imports and Exports
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FDF Dossiers
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Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Carbocysteine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Carbocysteine, including repackagers and relabelers. The FDA regulates Carbocysteine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Carbocysteine 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 Carbocysteine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Carbocysteine supplier is an individual or a company that provides Carbocysteine active pharmaceutical ingredient (API) or Carbocysteine finished formulations upon request. The Carbocysteine suppliers may include Carbocysteine API manufacturers, exporters, distributors and traders.
click here to find a list of Carbocysteine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Carbocysteine DMF (Drug Master File) is a document detailing the whole manufacturing process of Carbocysteine active pharmaceutical ingredient (API) in detail. Different forms of Carbocysteine DMFs exist exist since differing nations have different regulations, such as Carbocysteine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Carbocysteine DMF submitted to regulatory agencies in the US is known as a USDMF. Carbocysteine USDMF includes data on Carbocysteine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Carbocysteine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Carbocysteine 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 Carbocysteine Drug Master File in Japan (Carbocysteine JDMF) empowers Carbocysteine 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 Carbocysteine JDMF during the approval evaluation for pharmaceutical products. At the time of Carbocysteine 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 Carbocysteine suppliers with JDMF on PharmaCompass.
A Carbocysteine CEP of the European Pharmacopoeia monograph is often referred to as a Carbocysteine Certificate of Suitability (COS). The purpose of a Carbocysteine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Carbocysteine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Carbocysteine to their clients by showing that a Carbocysteine CEP has been issued for it. The manufacturer submits a Carbocysteine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Carbocysteine CEP holder for the record. Additionally, the data presented in the Carbocysteine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Carbocysteine DMF.
A Carbocysteine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Carbocysteine 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 Carbocysteine suppliers with CEP (COS) on PharmaCompass.
A Carbocysteine written confirmation (Carbocysteine WC) is an official document issued by a regulatory agency to a Carbocysteine manufacturer, verifying that the manufacturing facility of a Carbocysteine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Carbocysteine APIs or Carbocysteine finished pharmaceutical products to another nation, regulatory agencies frequently require a Carbocysteine WC (written confirmation) as part of the regulatory process.
click here to find a list of Carbocysteine 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 Carbocysteine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Carbocysteine 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 Carbocysteine 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 Carbocysteine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Carbocysteine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Carbocysteine suppliers with NDC on PharmaCompass.
Carbocysteine 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 Carbocysteine 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 Carbocysteine GMP manufacturer or Carbocysteine GMP API supplier for your needs.
A Carbocysteine CoA (Certificate of Analysis) is a formal document that attests to Carbocysteine's compliance with Carbocysteine specifications and serves as a tool for batch-level quality control.
Carbocysteine CoA mostly includes findings from lab analyses of a specific batch. For each Carbocysteine 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.
Carbocysteine may be tested according to a variety of international standards, such as European Pharmacopoeia (Carbocysteine EP), Carbocysteine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Carbocysteine USP).
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