Synopsis
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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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DOSAGE - CAPSULE;ORAL - 0.4MG
USFDA APPLICATION NUMBER - 20579
DOSAGE - CAPSULE;ORAL - 0.5MG;0.4MG
USFDA APPLICATION NUMBER - 22460
Related Excipient Companies
EUROAPI
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qianhao Chemical (Hebei) Co., Ltd
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Silverline Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Valens Pharmachem
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Controlled & Modified Release
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Topical
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Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
ABOUT THIS PAGE
18
PharmaCompass offers a list of Tamsulosin 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 Tamsulosin manufacturer or Tamsulosin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tamsulosin manufacturer or Tamsulosin supplier.
PharmaCompass also assists you with knowing the Tamsulosin API Price utilized in the formulation of products. Tamsulosin API Price is not always fixed or binding as the Tamsulosin Price is obtained through a variety of data sources. The Tamsulosin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Flomax manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Flomax, including repackagers and relabelers. The FDA regulates Flomax manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Flomax 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 Flomax manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Flomax supplier is an individual or a company that provides Flomax active pharmaceutical ingredient (API) or Flomax finished formulations upon request. The Flomax suppliers may include Flomax API manufacturers, exporters, distributors and traders.
click here to find a list of Flomax suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Flomax DMF (Drug Master File) is a document detailing the whole manufacturing process of Flomax active pharmaceutical ingredient (API) in detail. Different forms of Flomax DMFs exist exist since differing nations have different regulations, such as Flomax USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Flomax DMF submitted to regulatory agencies in the US is known as a USDMF. Flomax USDMF includes data on Flomax's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Flomax USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Flomax 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 Flomax Drug Master File in Japan (Flomax JDMF) empowers Flomax 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 Flomax JDMF during the approval evaluation for pharmaceutical products. At the time of Flomax 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 Flomax 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 Flomax Drug Master File in Korea (Flomax KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Flomax. The MFDS reviews the Flomax KDMF as part of the drug registration process and uses the information provided in the Flomax KDMF to evaluate the safety and efficacy of the drug.
After submitting a Flomax 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 Flomax API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Flomax suppliers with KDMF on PharmaCompass.
A Flomax CEP of the European Pharmacopoeia monograph is often referred to as a Flomax Certificate of Suitability (COS). The purpose of a Flomax CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Flomax EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Flomax to their clients by showing that a Flomax CEP has been issued for it. The manufacturer submits a Flomax CEP (COS) as part of the market authorization procedure, and it takes on the role of a Flomax CEP holder for the record. Additionally, the data presented in the Flomax CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Flomax DMF.
A Flomax CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Flomax CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Flomax suppliers with CEP (COS) on PharmaCompass.
A Flomax written confirmation (Flomax WC) is an official document issued by a regulatory agency to a Flomax manufacturer, verifying that the manufacturing facility of a Flomax active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Flomax APIs or Flomax finished pharmaceutical products to another nation, regulatory agencies frequently require a Flomax WC (written confirmation) as part of the regulatory process.
click here to find a list of Flomax 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 Flomax as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Flomax 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 Flomax 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 Flomax and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Flomax NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Flomax suppliers with NDC on PharmaCompass.
Flomax 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 Flomax 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 Flomax GMP manufacturer or Flomax GMP API supplier for your needs.
A Flomax CoA (Certificate of Analysis) is a formal document that attests to Flomax's compliance with Flomax specifications and serves as a tool for batch-level quality control.
Flomax CoA mostly includes findings from lab analyses of a specific batch. For each Flomax 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.
Flomax may be tested according to a variety of international standards, such as European Pharmacopoeia (Flomax EP), Flomax JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Flomax USP).
