Synopsis
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CEP/COS
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VMF
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
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USDMF
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
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DOSAGE - CAPSULE;ORAL - 4MG
USFDA APPLICATION NUMBER - 22206
DOSAGE - CAPSULE;ORAL - 8MG
USFDA APPLICATION NUMBER - 22206
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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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 Rapilif manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rapilif, including repackagers and relabelers. The FDA regulates Rapilif manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rapilif 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 Rapilif manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rapilif supplier is an individual or a company that provides Rapilif active pharmaceutical ingredient (API) or Rapilif finished formulations upon request. The Rapilif suppliers may include Rapilif API manufacturers, exporters, distributors and traders.
click here to find a list of Rapilif suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rapilif DMF (Drug Master File) is a document detailing the whole manufacturing process of Rapilif active pharmaceutical ingredient (API) in detail. Different forms of Rapilif DMFs exist exist since differing nations have different regulations, such as Rapilif USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rapilif DMF submitted to regulatory agencies in the US is known as a USDMF. Rapilif USDMF includes data on Rapilif's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rapilif USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rapilif 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 Rapilif Drug Master File in Japan (Rapilif JDMF) empowers Rapilif 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 Rapilif JDMF during the approval evaluation for pharmaceutical products. At the time of Rapilif 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 Rapilif 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 Rapilif Drug Master File in Korea (Rapilif KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Rapilif. The MFDS reviews the Rapilif KDMF as part of the drug registration process and uses the information provided in the Rapilif KDMF to evaluate the safety and efficacy of the drug.
After submitting a Rapilif 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 Rapilif API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Rapilif suppliers with KDMF on PharmaCompass.
A Rapilif written confirmation (Rapilif WC) is an official document issued by a regulatory agency to a Rapilif manufacturer, verifying that the manufacturing facility of a Rapilif active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Rapilif APIs or Rapilif finished pharmaceutical products to another nation, regulatory agencies frequently require a Rapilif WC (written confirmation) as part of the regulatory process.
click here to find a list of Rapilif 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 Rapilif as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Rapilif 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 Rapilif 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 Rapilif and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Rapilif NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Rapilif suppliers with NDC on PharmaCompass.
Rapilif 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 Rapilif 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 Rapilif GMP manufacturer or Rapilif GMP API supplier for your needs.
A Rapilif CoA (Certificate of Analysis) is a formal document that attests to Rapilif's compliance with Rapilif specifications and serves as a tool for batch-level quality control.
Rapilif CoA mostly includes findings from lab analyses of a specific batch. For each Rapilif 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.
Rapilif may be tested according to a variety of international standards, such as European Pharmacopoeia (Rapilif EP), Rapilif JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rapilif USP).
