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