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