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API SUPPLIERS
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
KDMF
ASMF 
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
ASMF
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ABOUT THIS PAGE
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PharmaCompass offers a list of Tofisopam 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 Tofisopam manufacturer or Tofisopam supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tofisopam manufacturer or Tofisopam supplier.
PharmaCompass also assists you with knowing the Tofisopam API Price utilized in the formulation of products. Tofisopam API Price is not always fixed or binding as the Tofisopam Price is obtained through a variety of data sources. The Tofisopam Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A dextofisopam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of dextofisopam, including repackagers and relabelers. The FDA regulates dextofisopam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. dextofisopam 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 dextofisopam manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A dextofisopam supplier is an individual or a company that provides dextofisopam active pharmaceutical ingredient (API) or dextofisopam finished formulations upon request. The dextofisopam suppliers may include dextofisopam API manufacturers, exporters, distributors and traders.
click here to find a list of dextofisopam suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price 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 dextofisopam Drug Master File in Japan (dextofisopam JDMF) empowers dextofisopam 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 dextofisopam JDMF during the approval evaluation for pharmaceutical products. At the time of dextofisopam 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 dextofisopam 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 dextofisopam Drug Master File in Korea (dextofisopam KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of dextofisopam. The MFDS reviews the dextofisopam KDMF as part of the drug registration process and uses the information provided in the dextofisopam KDMF to evaluate the safety and efficacy of the drug.
After submitting a dextofisopam 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 dextofisopam API can apply through the Korea Drug Master File (KDMF).
click here to find a list of dextofisopam suppliers with KDMF on PharmaCompass.
A dextofisopam written confirmation (dextofisopam WC) is an official document issued by a regulatory agency to a dextofisopam manufacturer, verifying that the manufacturing facility of a dextofisopam active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting dextofisopam APIs or dextofisopam finished pharmaceutical products to another nation, regulatory agencies frequently require a dextofisopam WC (written confirmation) as part of the regulatory process.
click here to find a list of dextofisopam suppliers with Written Confirmation (WC) on PharmaCompass.
dextofisopam 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 dextofisopam 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 dextofisopam GMP manufacturer or dextofisopam GMP API supplier for your needs.
A dextofisopam CoA (Certificate of Analysis) is a formal document that attests to dextofisopam's compliance with dextofisopam specifications and serves as a tool for batch-level quality control.
dextofisopam CoA mostly includes findings from lab analyses of a specific batch. For each dextofisopam 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.
dextofisopam may be tested according to a variety of international standards, such as European Pharmacopoeia (dextofisopam EP), dextofisopam JP (Japanese Pharmacopeia) and the US Pharmacopoeia (dextofisopam USP).
