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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 (3s,5s,7s)-adamantan-1-amine hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (3s,5s,7s)-adamantan-1-amine hydrochloride, including repackagers and relabelers. The FDA regulates (3s,5s,7s)-adamantan-1-amine hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (3s,5s,7s)-adamantan-1-amine 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.
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A (3s,5s,7s)-adamantan-1-amine hydrochloride supplier is an individual or a company that provides (3s,5s,7s)-adamantan-1-amine hydrochloride active pharmaceutical ingredient (API) or (3s,5s,7s)-adamantan-1-amine hydrochloride finished formulations upon request. The (3s,5s,7s)-adamantan-1-amine hydrochloride suppliers may include (3s,5s,7s)-adamantan-1-amine hydrochloride API manufacturers, exporters, distributors and traders.
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A (3s,5s,7s)-adamantan-1-amine hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of (3s,5s,7s)-adamantan-1-amine hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of (3s,5s,7s)-adamantan-1-amine hydrochloride DMFs exist exist since differing nations have different regulations, such as (3s,5s,7s)-adamantan-1-amine hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A (3s,5s,7s)-adamantan-1-amine hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. (3s,5s,7s)-adamantan-1-amine hydrochloride USDMF includes data on (3s,5s,7s)-adamantan-1-amine hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The (3s,5s,7s)-adamantan-1-amine hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 (3s,5s,7s)-adamantan-1-amine hydrochloride Drug Master File in Japan ((3s,5s,7s)-adamantan-1-amine hydrochloride JDMF) empowers (3s,5s,7s)-adamantan-1-amine 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 (3s,5s,7s)-adamantan-1-amine hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of (3s,5s,7s)-adamantan-1-amine hydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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A (3s,5s,7s)-adamantan-1-amine hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a (3s,5s,7s)-adamantan-1-amine hydrochloride Certificate of Suitability (COS). The purpose of a (3s,5s,7s)-adamantan-1-amine hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of (3s,5s,7s)-adamantan-1-amine hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of (3s,5s,7s)-adamantan-1-amine hydrochloride to their clients by showing that a (3s,5s,7s)-adamantan-1-amine hydrochloride CEP has been issued for it. The manufacturer submits a (3s,5s,7s)-adamantan-1-amine hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a (3s,5s,7s)-adamantan-1-amine hydrochloride CEP holder for the record. Additionally, the data presented in the (3s,5s,7s)-adamantan-1-amine hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the (3s,5s,7s)-adamantan-1-amine hydrochloride DMF.
A (3s,5s,7s)-adamantan-1-amine hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. (3s,5s,7s)-adamantan-1-amine hydrochloride CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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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 (3s,5s,7s)-adamantan-1-amine hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for (3s,5s,7s)-adamantan-1-amine 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 (3s,5s,7s)-adamantan-1-amine 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 (3s,5s,7s)-adamantan-1-amine hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a (3s,5s,7s)-adamantan-1-amine hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
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(3s,5s,7s)-adamantan-1-amine 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 (3s,5s,7s)-adamantan-1-amine 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 (3s,5s,7s)-adamantan-1-amine hydrochloride GMP manufacturer or (3s,5s,7s)-adamantan-1-amine hydrochloride GMP API supplier for your needs.
A (3s,5s,7s)-adamantan-1-amine hydrochloride CoA (Certificate of Analysis) is a formal document that attests to (3s,5s,7s)-adamantan-1-amine hydrochloride's compliance with (3s,5s,7s)-adamantan-1-amine hydrochloride specifications and serves as a tool for batch-level quality control.
(3s,5s,7s)-adamantan-1-amine hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each (3s,5s,7s)-adamantan-1-amine 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.
(3s,5s,7s)-adamantan-1-amine hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia ((3s,5s,7s)-adamantan-1-amine hydrochloride EP), (3s,5s,7s)-adamantan-1-amine hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia ((3s,5s,7s)-adamantan-1-amine hydrochloride USP).
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