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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 ratiopharm manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Memantine ratiopharm, including repackagers and relabelers. The FDA regulates Memantine ratiopharm manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Memantine ratiopharm 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 ratiopharm manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Memantine ratiopharm supplier is an individual or a company that provides Memantine ratiopharm active pharmaceutical ingredient (API) or Memantine ratiopharm finished formulations upon request. The Memantine ratiopharm suppliers may include Memantine ratiopharm API manufacturers, exporters, distributors and traders.
click here to find a list of Memantine ratiopharm suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Memantine ratiopharm DMF (Drug Master File) is a document detailing the whole manufacturing process of Memantine ratiopharm active pharmaceutical ingredient (API) in detail. Different forms of Memantine ratiopharm DMFs exist exist since differing nations have different regulations, such as Memantine ratiopharm USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Memantine ratiopharm DMF submitted to regulatory agencies in the US is known as a USDMF. Memantine ratiopharm USDMF includes data on Memantine ratiopharm's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Memantine ratiopharm USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Memantine ratiopharm 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 ratiopharm Drug Master File in Japan (Memantine ratiopharm JDMF) empowers Memantine ratiopharm 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 ratiopharm JDMF during the approval evaluation for pharmaceutical products. At the time of Memantine ratiopharm 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 ratiopharm 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 ratiopharm Drug Master File in Korea (Memantine ratiopharm KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Memantine ratiopharm. The MFDS reviews the Memantine ratiopharm KDMF as part of the drug registration process and uses the information provided in the Memantine ratiopharm KDMF to evaluate the safety and efficacy of the drug.
After submitting a Memantine ratiopharm 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 ratiopharm API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Memantine ratiopharm suppliers with KDMF on PharmaCompass.
A Memantine ratiopharm written confirmation (Memantine ratiopharm WC) is an official document issued by a regulatory agency to a Memantine ratiopharm manufacturer, verifying that the manufacturing facility of a Memantine ratiopharm active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Memantine ratiopharm APIs or Memantine ratiopharm finished pharmaceutical products to another nation, regulatory agencies frequently require a Memantine ratiopharm WC (written confirmation) as part of the regulatory process.
click here to find a list of Memantine ratiopharm 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 ratiopharm as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Memantine ratiopharm 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 ratiopharm 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 ratiopharm and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Memantine ratiopharm NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Memantine ratiopharm suppliers with NDC on PharmaCompass.
Memantine ratiopharm 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 ratiopharm 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 ratiopharm GMP manufacturer or Memantine ratiopharm GMP API supplier for your needs.
A Memantine ratiopharm CoA (Certificate of Analysis) is a formal document that attests to Memantine ratiopharm's compliance with Memantine ratiopharm specifications and serves as a tool for batch-level quality control.
Memantine ratiopharm CoA mostly includes findings from lab analyses of a specific batch. For each Memantine ratiopharm 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 ratiopharm may be tested according to a variety of international standards, such as European Pharmacopoeia (Memantine ratiopharm EP), Memantine ratiopharm JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Memantine ratiopharm USP).
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