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API SUPPLIERS
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USDMF
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Evonik
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
33
PharmaCompass offers a list of Flavoxate 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 Flavoxate manufacturer or Flavoxate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Flavoxate manufacturer or Flavoxate supplier.
PharmaCompass also assists you with knowing the Flavoxate API Price utilized in the formulation of products. Flavoxate API Price is not always fixed or binding as the Flavoxate Price is obtained through a variety of data sources. The Flavoxate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Flavoxate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Flavoxate, including repackagers and relabelers. The FDA regulates Flavoxate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Flavoxate 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 Flavoxate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Flavoxate supplier is an individual or a company that provides Flavoxate active pharmaceutical ingredient (API) or Flavoxate finished formulations upon request. The Flavoxate suppliers may include Flavoxate API manufacturers, exporters, distributors and traders.
click here to find a list of Flavoxate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Flavoxate DMF (Drug Master File) is a document detailing the whole manufacturing process of Flavoxate active pharmaceutical ingredient (API) in detail. Different forms of Flavoxate DMFs exist exist since differing nations have different regulations, such as Flavoxate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Flavoxate DMF submitted to regulatory agencies in the US is known as a USDMF. Flavoxate USDMF includes data on Flavoxate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Flavoxate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Flavoxate 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 Flavoxate Drug Master File in Japan (Flavoxate JDMF) empowers Flavoxate 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 Flavoxate JDMF during the approval evaluation for pharmaceutical products. At the time of Flavoxate 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 Flavoxate 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 Flavoxate Drug Master File in Korea (Flavoxate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Flavoxate. The MFDS reviews the Flavoxate KDMF as part of the drug registration process and uses the information provided in the Flavoxate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Flavoxate 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 Flavoxate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Flavoxate suppliers with KDMF on PharmaCompass.
A Flavoxate written confirmation (Flavoxate WC) is an official document issued by a regulatory agency to a Flavoxate manufacturer, verifying that the manufacturing facility of a Flavoxate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Flavoxate APIs or Flavoxate finished pharmaceutical products to another nation, regulatory agencies frequently require a Flavoxate WC (written confirmation) as part of the regulatory process.
click here to find a list of Flavoxate 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 Flavoxate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Flavoxate 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 Flavoxate 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 Flavoxate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Flavoxate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Flavoxate suppliers with NDC on PharmaCompass.
Flavoxate 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 Flavoxate 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 Flavoxate GMP manufacturer or Flavoxate GMP API supplier for your needs.
A Flavoxate CoA (Certificate of Analysis) is a formal document that attests to Flavoxate's compliance with Flavoxate specifications and serves as a tool for batch-level quality control.
Flavoxate CoA mostly includes findings from lab analyses of a specific batch. For each Flavoxate 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.
Flavoxate may be tested according to a variety of international standards, such as European Pharmacopoeia (Flavoxate EP), Flavoxate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Flavoxate USP).
