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