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