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