US DMFs Filed
USA (Orange Book)
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 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amantadine, including repackagers and relabelers. The FDA regulates Amantadine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amantadine 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Amantadine supplier is an individual or a company that provides Amantadine active pharmaceutical ingredient (API) or Amantadine finished formulations upon request. The Amantadine suppliers may include Amantadine API manufacturers, exporters, distributors and traders.
CLICK HERE to find a list of Amantadine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Drug Master File in Japan (Amantadine JDMF) empowers Amantadine 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Amantadine 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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