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PharmaCompass offers a list of Benfotiamine 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 Benfotiamine manufacturer or Benfotiamine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Benfotiamine manufacturer or Benfotiamine supplier.
PharmaCompass also assists you with knowing the Benfotiamine API Price utilized in the formulation of products. Benfotiamine API Price is not always fixed or binding as the Benfotiamine Price is obtained through a variety of data sources. The Benfotiamine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Benphothiamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Benphothiamine, including repackagers and relabelers. The FDA regulates Benphothiamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Benphothiamine 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 Benphothiamine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Benphothiamine supplier is an individual or a company that provides Benphothiamine active pharmaceutical ingredient (API) or Benphothiamine finished formulations upon request. The Benphothiamine suppliers may include Benphothiamine API manufacturers, exporters, distributors and traders.
click here to find a list of Benphothiamine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Benphothiamine DMF (Drug Master File) is a document detailing the whole manufacturing process of Benphothiamine active pharmaceutical ingredient (API) in detail. Different forms of Benphothiamine DMFs exist exist since differing nations have different regulations, such as Benphothiamine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Benphothiamine DMF submitted to regulatory agencies in the US is known as a USDMF. Benphothiamine USDMF includes data on Benphothiamine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Benphothiamine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Benphothiamine 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 Benphothiamine Drug Master File in Japan (Benphothiamine JDMF) empowers Benphothiamine 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 Benphothiamine JDMF during the approval evaluation for pharmaceutical products. At the time of Benphothiamine 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 Benphothiamine suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Benphothiamine Drug Master File in Korea (Benphothiamine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Benphothiamine. The MFDS reviews the Benphothiamine KDMF as part of the drug registration process and uses the information provided in the Benphothiamine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Benphothiamine KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Benphothiamine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Benphothiamine suppliers with KDMF on PharmaCompass.
A Benphothiamine written confirmation (Benphothiamine WC) is an official document issued by a regulatory agency to a Benphothiamine manufacturer, verifying that the manufacturing facility of a Benphothiamine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Benphothiamine APIs or Benphothiamine finished pharmaceutical products to another nation, regulatory agencies frequently require a Benphothiamine WC (written confirmation) as part of the regulatory process.
click here to find a list of Benphothiamine suppliers with Written Confirmation (WC) on PharmaCompass.
Benphothiamine 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 Benphothiamine 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 Benphothiamine GMP manufacturer or Benphothiamine GMP API supplier for your needs.
A Benphothiamine CoA (Certificate of Analysis) is a formal document that attests to Benphothiamine's compliance with Benphothiamine specifications and serves as a tool for batch-level quality control.
Benphothiamine CoA mostly includes findings from lab analyses of a specific batch. For each Benphothiamine 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.
Benphothiamine may be tested according to a variety of international standards, such as European Pharmacopoeia (Benphothiamine EP), Benphothiamine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Benphothiamine USP).
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