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