01 1Daito Co., Ltd.
02 2Sanyo Chemical Research Institute Co., Ltd.
01 3Nicardipine hydrochloride
01 2Gabon
02 1Japan
Japanese Pharmacopoeia Nicardipine Hydrochloride (for manufacturing only)
Registration Number : 218MF11014
Registrant's Address : 326 Yokamachi, Toyama City, Toyama Prefecture
Initial Date of Registration : 2006-12-18
Latest Date of Registration : 2006-12-18
Registration Number : 224MF10022
Registrant's Address : 148-1 Tajii, Mihara-ku, Sakai City, Osaka Prefecture
Initial Date of Registration : 2012-02-01
Latest Date of Registration : 2012-02-01
Registration Number : 219MF10079
Registrant's Address : 148-1 Tajii, Mihara-ku, Sakai City, Osaka Prefecture
Initial Date of Registration : 2007-03-14
Latest Date of Registration : 2007-03-14
A Nicardipine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nicardipine, including repackagers and relabelers. The FDA regulates Nicardipine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nicardipine 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 Nicardipine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nicardipine supplier is an individual or a company that provides Nicardipine active pharmaceutical ingredient (API) or Nicardipine finished formulations upon request. The Nicardipine suppliers may include Nicardipine API manufacturers, exporters, distributors and traders.
click here to find a list of Nicardipine 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 Nicardipine Drug Master File in Japan (Nicardipine JDMF) empowers Nicardipine 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 Nicardipine JDMF during the approval evaluation for pharmaceutical products. At the time of Nicardipine 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 Nicardipine suppliers with JDMF on PharmaCompass.
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