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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
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DOSAGE - TABLET;ORAL - 10MG
USFDA APPLICATION NUMBER - 21487
DOSAGE - TABLET;ORAL - 5MG
USFDA APPLICATION NUMBER - 21487
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 14M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 14MG
USFDA APPLICATION NUMBER - 22525
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 21M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 21MG
USFDA APPLICATION NUMBER - 22525
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 28M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 28MG
USFDA APPLICATION NUMBER - 22525
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 7MG...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22525
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ABOUT THIS PAGE
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PharmaCompass offers a list of Memantine 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 Memantine Hydrochloride manufacturer or Memantine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Memantine Hydrochloride manufacturer or Memantine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Memantine Hydrochloride API Price utilized in the formulation of products. Memantine Hydrochloride API Price is not always fixed or binding as the Memantine Hydrochloride Price is obtained through a variety of data sources. The Memantine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Memantine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Memantine Hydrochloride, including repackagers and relabelers. The FDA regulates Memantine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Memantine 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 Memantine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Memantine Hydrochloride supplier is an individual or a company that provides Memantine Hydrochloride active pharmaceutical ingredient (API) or Memantine Hydrochloride finished formulations upon request. The Memantine Hydrochloride suppliers may include Memantine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Memantine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Memantine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Memantine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Memantine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Memantine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Memantine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Memantine Hydrochloride USDMF includes data on Memantine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Memantine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Memantine 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 Memantine Hydrochloride Drug Master File in Japan (Memantine Hydrochloride JDMF) empowers Memantine 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 Memantine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Memantine 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 Memantine Hydrochloride suppliers with JDMF 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 Memantine Hydrochloride Drug Master File in Korea (Memantine Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Memantine Hydrochloride. The MFDS reviews the Memantine Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Memantine Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Memantine Hydrochloride 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 Memantine Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Memantine Hydrochloride suppliers with KDMF on PharmaCompass.
A Memantine Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Memantine Hydrochloride Certificate of Suitability (COS). The purpose of a Memantine Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Memantine Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Memantine Hydrochloride to their clients by showing that a Memantine Hydrochloride CEP has been issued for it. The manufacturer submits a Memantine Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Memantine Hydrochloride CEP holder for the record. Additionally, the data presented in the Memantine Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Memantine Hydrochloride DMF.
A Memantine Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Memantine 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 Memantine Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Memantine Hydrochloride written confirmation (Memantine Hydrochloride WC) is an official document issued by a regulatory agency to a Memantine Hydrochloride manufacturer, verifying that the manufacturing facility of a Memantine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Memantine Hydrochloride APIs or Memantine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Memantine Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Memantine Hydrochloride 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 Memantine Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Memantine 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 Memantine 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 Memantine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Memantine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Memantine Hydrochloride suppliers with NDC on PharmaCompass.
Memantine 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 Memantine 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 Memantine Hydrochloride GMP manufacturer or Memantine Hydrochloride GMP API supplier for your needs.
A Memantine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Memantine Hydrochloride's compliance with Memantine Hydrochloride specifications and serves as a tool for batch-level quality control.
Memantine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Memantine 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.
Memantine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Memantine Hydrochloride EP), Memantine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Memantine Hydrochloride USP).
