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01 1Zhejiang Apeloa Kangyu Pharmaceutical Co. , Ltd.
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01 1Amantadine hydrochloride
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01 1China
Registration Number : 223MF10070
Registrant's Address : 333, Jiangnan Road, Hengdian, Dongyang, Zhejiang, 322118, China.
Initial Date of Registration : 2011-05-27
Latest Date of Registration : 2011-05-27
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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 Novartis Brand of Amantadine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Novartis Brand of Amantadine Hydrochloride, including repackagers and relabelers. The FDA regulates Novartis Brand of Amantadine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Novartis Brand of Amantadine 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 Novartis Brand of Amantadine Hydrochloride supplier is an individual or a company that provides Novartis Brand of Amantadine Hydrochloride active pharmaceutical ingredient (API) or Novartis Brand of Amantadine Hydrochloride finished formulations upon request. The Novartis Brand of Amantadine Hydrochloride suppliers may include Novartis Brand of Amantadine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Novartis Brand of Amantadine Hydrochloride 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 Novartis Brand of Amantadine Hydrochloride Drug Master File in Japan (Novartis Brand of Amantadine Hydrochloride JDMF) empowers Novartis Brand of Amantadine 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 Novartis Brand of Amantadine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Novartis Brand of Amantadine 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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