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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Benzhexol hydrochloride 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 Benzhexol hydrochloride manufacturer or Benzhexol hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Benzhexol hydrochloride manufacturer or Benzhexol hydrochloride supplier.
PharmaCompass also assists you with knowing the Benzhexol hydrochloride API Price utilized in the formulation of products. Benzhexol hydrochloride API Price is not always fixed or binding as the Benzhexol hydrochloride Price is obtained through a variety of data sources. The Benzhexol hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Benzhexol hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Benzhexol hydrochloride, including repackagers and relabelers. The FDA regulates Benzhexol hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Benzhexol hydrochloride 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 Benzhexol hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Benzhexol hydrochloride supplier is an individual or a company that provides Benzhexol hydrochloride active pharmaceutical ingredient (API) or Benzhexol hydrochloride finished formulations upon request. The Benzhexol hydrochloride suppliers may include Benzhexol hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Benzhexol hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Benzhexol hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Benzhexol hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Benzhexol hydrochloride DMFs exist exist since differing nations have different regulations, such as Benzhexol hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Benzhexol hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Benzhexol hydrochloride USDMF includes data on Benzhexol hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Benzhexol hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Benzhexol hydrochloride 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 Benzhexol hydrochloride Drug Master File in Japan (Benzhexol hydrochloride JDMF) empowers Benzhexol hydrochloride 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 Benzhexol hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Benzhexol hydrochloride 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 Benzhexol hydrochloride suppliers with JDMF on PharmaCompass.
A Benzhexol hydrochloride written confirmation (Benzhexol hydrochloride WC) is an official document issued by a regulatory agency to a Benzhexol hydrochloride manufacturer, verifying that the manufacturing facility of a Benzhexol hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Benzhexol hydrochloride APIs or Benzhexol hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Benzhexol hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Benzhexol hydrochloride 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 Benzhexol hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Benzhexol hydrochloride 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 Benzhexol hydrochloride 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 Benzhexol hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Benzhexol hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Benzhexol hydrochloride suppliers with NDC on PharmaCompass.
Benzhexol hydrochloride 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 Benzhexol hydrochloride 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 Benzhexol hydrochloride GMP manufacturer or Benzhexol hydrochloride GMP API supplier for your needs.
A Benzhexol hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Benzhexol hydrochloride's compliance with Benzhexol hydrochloride specifications and serves as a tool for batch-level quality control.
Benzhexol hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Benzhexol hydrochloride 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.
Benzhexol hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Benzhexol hydrochloride EP), Benzhexol hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Benzhexol hydrochloride USP).
