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ABOUT THIS PAGE
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PharmaCompass offers a list of Bromhexine Hydrochloride 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 Bromhexine Hydrochloride manufacturer or Bromhexine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Bromhexine Hydrochloride manufacturer or Bromhexine Hydrochloride supplier.
A Bromhexine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bromhexine, including repackagers and relabelers. The FDA regulates Bromhexine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bromhexine 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 Bromhexine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Bromhexine supplier is an individual or a company that provides Bromhexine active pharmaceutical ingredient (API) or Bromhexine finished formulations upon request. The Bromhexine suppliers may include Bromhexine API manufacturers, exporters, distributors and traders.
click here to find a list of Bromhexine suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information 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 Bromhexine Drug Master File in Japan (Bromhexine JDMF) empowers Bromhexine 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 Bromhexine JDMF during the approval evaluation for pharmaceutical products. At the time of Bromhexine 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 Bromhexine suppliers with JDMF on PharmaCompass.
A Bromhexine CEP of the European Pharmacopoeia monograph is often referred to as a Bromhexine Certificate of Suitability (COS). The purpose of a Bromhexine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Bromhexine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Bromhexine to their clients by showing that a Bromhexine CEP has been issued for it. The manufacturer submits a Bromhexine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Bromhexine CEP holder for the record. Additionally, the data presented in the Bromhexine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Bromhexine DMF.
A Bromhexine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Bromhexine 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 Bromhexine suppliers with CEP (COS) on PharmaCompass.
A Bromhexine written confirmation (Bromhexine WC) is an official document issued by a regulatory agency to a Bromhexine manufacturer, verifying that the manufacturing facility of a Bromhexine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Bromhexine APIs or Bromhexine finished pharmaceutical products to another nation, regulatory agencies frequently require a Bromhexine WC (written confirmation) as part of the regulatory process.
click here to find a list of Bromhexine 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 Bromhexine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Bromhexine 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 Bromhexine 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 Bromhexine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Bromhexine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Bromhexine suppliers with NDC on PharmaCompass.
Bromhexine 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 Bromhexine GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Bromhexine GMP manufacturer or Bromhexine GMP API supplier for your needs.
A Bromhexine CoA (Certificate of Analysis) is a formal document that attests to Bromhexine's compliance with Bromhexine specifications and serves as a tool for batch-level quality control.
Bromhexine CoA mostly includes findings from lab analyses of a specific batch. For each Bromhexine 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.
Bromhexine may be tested according to a variety of international standards, such as European Pharmacopoeia (Bromhexine EP), Bromhexine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bromhexine USP).
