Synopsis
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VMF
DRUG PRODUCT COMPOSITIONS0
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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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REF. STANDARDS & IMPURITIES
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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 Tamsulosin Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tamsulosin Hydrochloride, including repackagers and relabelers. The FDA regulates Tamsulosin Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tamsulosin Hydrochloride 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 Tamsulosin Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tamsulosin Hydrochloride supplier is an individual or a company that provides Tamsulosin Hydrochloride active pharmaceutical ingredient (API) or Tamsulosin Hydrochloride finished formulations upon request. The Tamsulosin Hydrochloride suppliers may include Tamsulosin Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Tamsulosin Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tamsulosin Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Tamsulosin Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Tamsulosin Hydrochloride DMFs exist exist since differing nations have different regulations, such as Tamsulosin Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tamsulosin Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Tamsulosin Hydrochloride USDMF includes data on Tamsulosin Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tamsulosin Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tamsulosin Hydrochloride 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 Tamsulosin Hydrochloride Drug Master File in Japan (Tamsulosin Hydrochloride JDMF) empowers Tamsulosin Hydrochloride 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 Tamsulosin Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Tamsulosin Hydrochloride 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 Tamsulosin Hydrochloride 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 Tamsulosin Hydrochloride Drug Master File in Korea (Tamsulosin Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tamsulosin Hydrochloride. The MFDS reviews the Tamsulosin Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Tamsulosin Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tamsulosin Hydrochloride 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 Tamsulosin Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Tamsulosin Hydrochloride suppliers with KDMF on PharmaCompass.
A Tamsulosin Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Tamsulosin Hydrochloride Certificate of Suitability (COS). The purpose of a Tamsulosin Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Tamsulosin Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Tamsulosin Hydrochloride to their clients by showing that a Tamsulosin Hydrochloride CEP has been issued for it. The manufacturer submits a Tamsulosin Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Tamsulosin Hydrochloride CEP holder for the record. Additionally, the data presented in the Tamsulosin Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Tamsulosin Hydrochloride DMF.
A Tamsulosin Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Tamsulosin Hydrochloride 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 Tamsulosin Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Tamsulosin Hydrochloride written confirmation (Tamsulosin Hydrochloride WC) is an official document issued by a regulatory agency to a Tamsulosin Hydrochloride manufacturer, verifying that the manufacturing facility of a Tamsulosin Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tamsulosin Hydrochloride APIs or Tamsulosin Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Tamsulosin Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Tamsulosin Hydrochloride 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 Tamsulosin Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tamsulosin Hydrochloride 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 Tamsulosin Hydrochloride 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 Tamsulosin Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tamsulosin Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tamsulosin Hydrochloride suppliers with NDC on PharmaCompass.
Tamsulosin Hydrochloride 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 Tamsulosin Hydrochloride 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 Tamsulosin Hydrochloride GMP manufacturer or Tamsulosin Hydrochloride GMP API supplier for your needs.
A Tamsulosin Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Tamsulosin Hydrochloride's compliance with Tamsulosin Hydrochloride specifications and serves as a tool for batch-level quality control.
Tamsulosin Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Tamsulosin Hydrochloride 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.
Tamsulosin Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Tamsulosin Hydrochloride EP), Tamsulosin Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tamsulosin Hydrochloride USP).
