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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Dutasteride Tamsulosin Zentiva
Dosage Form : Capsule
Dosage Strength : 0.5mg;0.4mg
Packaging :
Approval Date : 12/10/2020
Application Number : 67959
Regulatory Info : Allowed
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Tamsulosin retard Zentiva
Dosage Form : Extended Release Capsule
Dosage Strength : 0.4mg
Packaging :
Approval Date : 19/06/2019
Application Number : 67254
Regulatory Info : Allowed
Registration Country : Switzerland
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
Regulatory Info : Authorised
Registration Country : Malta
Dutasteride; Tamsulosin Hydrochloride
Brand Name : Dutasteride/Tamsulosin Olpha
Dosage Form : Hard Capsule
Dosage Strength : 0.5MG; 0.4MG
Packaging :
Approval Date : 2021-08-18
Application Number :
Regulatory Info : Authorised
Registration Country : Malta
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
Regulatory Info : Prescription
Registration Country : Estonia
Brand Name : Dutasteride/Tamsulosin Olpha
Dosage Form : Capsule
Dosage Strength : 0.5mg; 0.4mg
Packaging :
Approval Date :
Application Number :
Regulatory Info : Prescription
Registration Country : Estonia
Towa International works to research, develop, manufacture, and market, generic and value-added medicines to patients around the world.
Regulatory Info :
Registration Country : Italy
Brand Name : TAMSULOSIN THINKS
Dosage Form : Hard Capsules With Modified Release
Dosage Strength : 0.4 mg
Packaging : 20 UNITS 0.4 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Towa International works to research, develop, manufacture, and market, generic and value-added medicines to patients around the world.
Regulatory Info :
Registration Country : Italy
Brand Name : TAMSULOSIN THINKS
Dosage Form : Modified Release Hard Capsules
Dosage Strength : 0.4 mg
Packaging : 30 UNITS 0.4 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Towa International works to research, develop, manufacture, and market, generic and value-added medicines to patients around the world.
Regulatory Info : Authorized
Registration Country : Spain
Tamsulosin Hydrochloride; Solifenacin Succinate
Brand Name : Solifenacina/Tamsulosina Pensa
Dosage Form : Modified Release Tablet
Dosage Strength : 6MG; 0.4 MG
Packaging :
Approval Date : 22-02-2023
Application Number : 88683
Regulatory Info : Authorized
Registration Country : Spain
Towa International works to research, develop, manufacture, and market, generic and value-added medicines to patients around the world.
Regulatory Info : Authorized
Registration Country : Spain
Tamsulosin Hydrochloride; Dutasteride
Brand Name : Dutasterida/Tamsulosina Pensa
Dosage Form : Hard Capsule
Dosage Strength : 0.5MG; 0.4 MG
Packaging :
Approval Date : 26-11-2019
Application Number : 84608
Regulatory Info : Authorized
Registration Country : Spain
Towa International works to research, develop, manufacture, and market, generic and value-added medicines to patients around the world.
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Tamsulosina Pensa Pharma
Dosage Form : Modified-Release Hard Capsule
Dosage Strength : 0.4MG
Packaging :
Approval Date : 04-07-2024
Application Number : 89682
Regulatory Info : Authorized
Registration Country : Spain
Towa International works to research, develop, manufacture, and market, generic and value-added medicines to patients around the world.
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Tamsulosina Pensa
Dosage Form : Extended-Release Hard Capsule
Dosage Strength : 0.4MG
Packaging :
Approval Date : 01-06-2007
Application Number : 68870
Regulatory Info : Authorized
Registration Country : Spain
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DOSAGE - CAPSULE;ORAL - 0.4MG
USFDA APPLICATION NUMBER - 20579
DOSAGE - CAPSULE;ORAL - 0.5MG;0.4MG
USFDA APPLICATION NUMBER - 22460
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ABOUT THIS PAGE
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PharmaCompass offers a list of Tamsulosin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, 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.
A 106138-88-9 (Parent) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 106138-88-9 (Parent), including repackagers and relabelers. The FDA regulates 106138-88-9 (Parent) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 106138-88-9 (Parent) 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 106138-88-9 (Parent) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A 106138-88-9 (Parent) supplier is an individual or a company that provides 106138-88-9 (Parent) active pharmaceutical ingredient (API) or 106138-88-9 (Parent) finished formulations upon request. The 106138-88-9 (Parent) suppliers may include 106138-88-9 (Parent) API manufacturers, exporters, distributors and traders.
click here to find a list of 106138-88-9 (Parent) suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A 106138-88-9 (Parent) DMF (Drug Master File) is a document detailing the whole manufacturing process of 106138-88-9 (Parent) active pharmaceutical ingredient (API) in detail. Different forms of 106138-88-9 (Parent) DMFs exist exist since differing nations have different regulations, such as 106138-88-9 (Parent) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 106138-88-9 (Parent) DMF submitted to regulatory agencies in the US is known as a USDMF. 106138-88-9 (Parent) USDMF includes data on 106138-88-9 (Parent)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 106138-88-9 (Parent) USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 106138-88-9 (Parent) 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 106138-88-9 (Parent) Drug Master File in Japan (106138-88-9 (Parent) JDMF) empowers 106138-88-9 (Parent) 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 106138-88-9 (Parent) JDMF during the approval evaluation for pharmaceutical products. At the time of 106138-88-9 (Parent) 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 106138-88-9 (Parent) 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 106138-88-9 (Parent) Drug Master File in Korea (106138-88-9 (Parent) KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 106138-88-9 (Parent). The MFDS reviews the 106138-88-9 (Parent) KDMF as part of the drug registration process and uses the information provided in the 106138-88-9 (Parent) KDMF to evaluate the safety and efficacy of the drug.
After submitting a 106138-88-9 (Parent) 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 106138-88-9 (Parent) API can apply through the Korea Drug Master File (KDMF).
click here to find a list of 106138-88-9 (Parent) suppliers with KDMF on PharmaCompass.
A 106138-88-9 (Parent) CEP of the European Pharmacopoeia monograph is often referred to as a 106138-88-9 (Parent) Certificate of Suitability (COS). The purpose of a 106138-88-9 (Parent) CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 106138-88-9 (Parent) EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 106138-88-9 (Parent) to their clients by showing that a 106138-88-9 (Parent) CEP has been issued for it. The manufacturer submits a 106138-88-9 (Parent) CEP (COS) as part of the market authorization procedure, and it takes on the role of a 106138-88-9 (Parent) CEP holder for the record. Additionally, the data presented in the 106138-88-9 (Parent) CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 106138-88-9 (Parent) DMF.
A 106138-88-9 (Parent) CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 106138-88-9 (Parent) 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 106138-88-9 (Parent) suppliers with CEP (COS) on PharmaCompass.
A 106138-88-9 (Parent) written confirmation (106138-88-9 (Parent) WC) is an official document issued by a regulatory agency to a 106138-88-9 (Parent) manufacturer, verifying that the manufacturing facility of a 106138-88-9 (Parent) active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 106138-88-9 (Parent) APIs or 106138-88-9 (Parent) finished pharmaceutical products to another nation, regulatory agencies frequently require a 106138-88-9 (Parent) WC (written confirmation) as part of the regulatory process.
click here to find a list of 106138-88-9 (Parent) 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 106138-88-9 (Parent) as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 106138-88-9 (Parent) 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 106138-88-9 (Parent) 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 106138-88-9 (Parent) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 106138-88-9 (Parent) NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of 106138-88-9 (Parent) suppliers with NDC on PharmaCompass.
106138-88-9 (Parent) 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 106138-88-9 (Parent) GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right 106138-88-9 (Parent) GMP manufacturer or 106138-88-9 (Parent) GMP API supplier for your needs.
A 106138-88-9 (Parent) CoA (Certificate of Analysis) is a formal document that attests to 106138-88-9 (Parent)'s compliance with 106138-88-9 (Parent) specifications and serves as a tool for batch-level quality control.
106138-88-9 (Parent) CoA mostly includes findings from lab analyses of a specific batch. For each 106138-88-9 (Parent) 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.
106138-88-9 (Parent) may be tested according to a variety of international standards, such as European Pharmacopoeia (106138-88-9 (Parent) EP), 106138-88-9 (Parent) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (106138-88-9 (Parent) USP).
