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