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
Gentec Pharmaceutical Group is focused on manufacturing & developing APIs/HPAPIs, Advanced Intermediates & Fine Chemicals.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
EU-WC
NDC
IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Jai Radhe Sales is your partner for all your sourcing needs.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
Capital Farma, a leading European pharmaceutical company focusing on the development & distribution of niche APIs & Pharma Services.
Sumar Biotech work together to Innovate & Manufacture Semi-synthetic, Synthetic & Fermentation API.
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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]NDC API
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : Status- Under Registration
Registration Country : Germany
Brand Name :
Dosage Form : Hard Capsule
Dosage Strength : 4MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Under Registration
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : Status- Under Registration
Registration Country : Germany
Brand Name :
Dosage Form : Hard Capsule
Dosage Strength : 8MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Under Registration
Registration Country : Germany
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]South Africa
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Dossiers
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : Status- Under Registration
Registration Country : Germany
Brand Name :
Dosage Form : Hard Capsule
Dosage Strength : 4MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Under Registration
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : Status- Under Registration
Registration Country : Germany
Brand Name :
Dosage Form : Hard Capsule
Dosage Strength : 8MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Under Registration
Registration Country : Germany
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
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 Silodyx manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Silodyx, including repackagers and relabelers. The FDA regulates Silodyx manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Silodyx 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 Silodyx manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Silodyx supplier is an individual or a company that provides Silodyx active pharmaceutical ingredient (API) or Silodyx finished formulations upon request. The Silodyx suppliers may include Silodyx API manufacturers, exporters, distributors and traders.
click here to find a list of Silodyx suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Silodyx DMF (Drug Master File) is a document detailing the whole manufacturing process of Silodyx active pharmaceutical ingredient (API) in detail. Different forms of Silodyx DMFs exist exist since differing nations have different regulations, such as Silodyx USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Silodyx DMF submitted to regulatory agencies in the US is known as a USDMF. Silodyx USDMF includes data on Silodyx's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Silodyx USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Silodyx 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 Silodyx Drug Master File in Japan (Silodyx JDMF) empowers Silodyx 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 Silodyx JDMF during the approval evaluation for pharmaceutical products. At the time of Silodyx 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 Silodyx 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 Silodyx Drug Master File in Korea (Silodyx KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Silodyx. The MFDS reviews the Silodyx KDMF as part of the drug registration process and uses the information provided in the Silodyx KDMF to evaluate the safety and efficacy of the drug.
After submitting a Silodyx 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 Silodyx API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Silodyx suppliers with KDMF on PharmaCompass.
A Silodyx written confirmation (Silodyx WC) is an official document issued by a regulatory agency to a Silodyx manufacturer, verifying that the manufacturing facility of a Silodyx active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Silodyx APIs or Silodyx finished pharmaceutical products to another nation, regulatory agencies frequently require a Silodyx WC (written confirmation) as part of the regulatory process.
click here to find a list of Silodyx 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 Silodyx as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Silodyx 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 Silodyx 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 Silodyx and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Silodyx NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Silodyx suppliers with NDC on PharmaCompass.
Silodyx 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 Silodyx 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 Silodyx GMP manufacturer or Silodyx GMP API supplier for your needs.
A Silodyx CoA (Certificate of Analysis) is a formal document that attests to Silodyx's compliance with Silodyx specifications and serves as a tool for batch-level quality control.
Silodyx CoA mostly includes findings from lab analyses of a specific batch. For each Silodyx 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.
Silodyx may be tested according to a variety of international standards, such as European Pharmacopoeia (Silodyx EP), Silodyx JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Silodyx USP).
