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VMF
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Evonik
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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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
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
Fillers, Diluents & Binders
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Solubilizers
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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
32
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 Omnic manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Omnic, including repackagers and relabelers. The FDA regulates Omnic manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Omnic 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 Omnic manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Omnic supplier is an individual or a company that provides Omnic active pharmaceutical ingredient (API) or Omnic finished formulations upon request. The Omnic suppliers may include Omnic API manufacturers, exporters, distributors and traders.
click here to find a list of Omnic suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Omnic DMF (Drug Master File) is a document detailing the whole manufacturing process of Omnic active pharmaceutical ingredient (API) in detail. Different forms of Omnic DMFs exist exist since differing nations have different regulations, such as Omnic USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Omnic DMF submitted to regulatory agencies in the US is known as a USDMF. Omnic USDMF includes data on Omnic's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Omnic USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Omnic 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 Omnic Drug Master File in Japan (Omnic JDMF) empowers Omnic 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 Omnic JDMF during the approval evaluation for pharmaceutical products. At the time of Omnic 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 Omnic 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 Omnic Drug Master File in Korea (Omnic KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Omnic. The MFDS reviews the Omnic KDMF as part of the drug registration process and uses the information provided in the Omnic KDMF to evaluate the safety and efficacy of the drug.
After submitting a Omnic 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 Omnic API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Omnic suppliers with KDMF on PharmaCompass.
A Omnic CEP of the European Pharmacopoeia monograph is often referred to as a Omnic Certificate of Suitability (COS). The purpose of a Omnic CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Omnic EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Omnic to their clients by showing that a Omnic CEP has been issued for it. The manufacturer submits a Omnic CEP (COS) as part of the market authorization procedure, and it takes on the role of a Omnic CEP holder for the record. Additionally, the data presented in the Omnic CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Omnic DMF.
A Omnic CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Omnic 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 Omnic suppliers with CEP (COS) on PharmaCompass.
A Omnic written confirmation (Omnic WC) is an official document issued by a regulatory agency to a Omnic manufacturer, verifying that the manufacturing facility of a Omnic active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Omnic APIs or Omnic finished pharmaceutical products to another nation, regulatory agencies frequently require a Omnic WC (written confirmation) as part of the regulatory process.
click here to find a list of Omnic 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 Omnic as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Omnic 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 Omnic 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 Omnic and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Omnic NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Omnic suppliers with NDC on PharmaCompass.
Omnic 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 Omnic 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 Omnic GMP manufacturer or Omnic GMP API supplier for your needs.
A Omnic CoA (Certificate of Analysis) is a formal document that attests to Omnic's compliance with Omnic specifications and serves as a tool for batch-level quality control.
Omnic CoA mostly includes findings from lab analyses of a specific batch. For each Omnic 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.
Omnic may be tested according to a variety of international standards, such as European Pharmacopoeia (Omnic EP), Omnic JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Omnic USP).
