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