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ABOUT THIS PAGE
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PharmaCompass offers a list of Thiamine Mononitrate 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 Thiamine Mononitrate manufacturer or Thiamine Mononitrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Thiamine Mononitrate manufacturer or Thiamine Mononitrate supplier.
PharmaCompass also assists you with knowing the Thiamine Mononitrate API Price utilized in the formulation of products. Thiamine Mononitrate API Price is not always fixed or binding as the Thiamine Mononitrate Price is obtained through a variety of data sources. The Thiamine Mononitrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Thiamine Mononitrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Thiamine Mononitrate, including repackagers and relabelers. The FDA regulates Thiamine Mononitrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Thiamine Mononitrate 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 Thiamine Mononitrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Thiamine Mononitrate supplier is an individual or a company that provides Thiamine Mononitrate active pharmaceutical ingredient (API) or Thiamine Mononitrate finished formulations upon request. The Thiamine Mononitrate suppliers may include Thiamine Mononitrate API manufacturers, exporters, distributors and traders.
click here to find a list of Thiamine Mononitrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Thiamine Mononitrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Thiamine Mononitrate active pharmaceutical ingredient (API) in detail. Different forms of Thiamine Mononitrate DMFs exist exist since differing nations have different regulations, such as Thiamine Mononitrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Thiamine Mononitrate DMF submitted to regulatory agencies in the US is known as a USDMF. Thiamine Mononitrate USDMF includes data on Thiamine Mononitrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Thiamine Mononitrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Thiamine Mononitrate 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 Thiamine Mononitrate Drug Master File in Japan (Thiamine Mononitrate JDMF) empowers Thiamine Mononitrate 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 Thiamine Mononitrate JDMF during the approval evaluation for pharmaceutical products. At the time of Thiamine Mononitrate 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 Thiamine Mononitrate suppliers with JDMF on PharmaCompass.
A Thiamine Mononitrate CEP of the European Pharmacopoeia monograph is often referred to as a Thiamine Mononitrate Certificate of Suitability (COS). The purpose of a Thiamine Mononitrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Thiamine Mononitrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Thiamine Mononitrate to their clients by showing that a Thiamine Mononitrate CEP has been issued for it. The manufacturer submits a Thiamine Mononitrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Thiamine Mononitrate CEP holder for the record. Additionally, the data presented in the Thiamine Mononitrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Thiamine Mononitrate DMF.
A Thiamine Mononitrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Thiamine Mononitrate 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 Thiamine Mononitrate suppliers with CEP (COS) on PharmaCompass.
Thiamine Mononitrate 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 Thiamine Mononitrate 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 Thiamine Mononitrate GMP manufacturer or Thiamine Mononitrate GMP API supplier for your needs.
A Thiamine Mononitrate CoA (Certificate of Analysis) is a formal document that attests to Thiamine Mononitrate's compliance with Thiamine Mononitrate specifications and serves as a tool for batch-level quality control.
Thiamine Mononitrate CoA mostly includes findings from lab analyses of a specific batch. For each Thiamine Mononitrate 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.
Thiamine Mononitrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Thiamine Mononitrate EP), Thiamine Mononitrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Thiamine Mononitrate USP).
