01 2JEIL PHARMACEUTICAL CO. , LTD.
02 1Permakem Asia Co., Ltd.
03 1Sanyo Chemical Research Institute Co., Ltd.
01 2Hydrochloric acid manidipine
02 1Manidipine Hydrochloride
03 1Manidipine hydrochloride
01 1Gabon
02 1Japan
03 2South Korea
Registration Number : 306MF10077
Registrant's Address : 343, Sapyeong-daero, Seocho-gu, Seoul, Korea
Initial Date of Registration : 2024-06-12
Latest Date of Registration : 2024-06-12
Registration Number : 217MF10410
Registrant's Address : 343, Sapyeong-daero, Seocho-gu, Seoul, Korea
Initial Date of Registration : 2005-08-19
Latest Date of Registration : 2006-06-09
Registration Number : 217MF10721
Registrant's Address : 1-10-11, Nihonbashi Horidomecho, Chuo-ku, Tokyo
Initial Date of Registration : 2005-10-07
Latest Date of Registration : 2008-07-31
Registration Number : 220MF10079
Registrant's Address : 148-1 Tajii, Mihara-ku, Sakai City, Osaka Prefecture
Initial Date of Registration : 2008-03-14
Latest Date of Registration : 2008-03-14
A Manidipine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Manidipine, including repackagers and relabelers. The FDA regulates Manidipine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Manidipine 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 Manidipine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Manidipine supplier is an individual or a company that provides Manidipine active pharmaceutical ingredient (API) or Manidipine finished formulations upon request. The Manidipine suppliers may include Manidipine API manufacturers, exporters, distributors and traders.
click here to find a list of Manidipine 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 Manidipine Drug Master File in Japan (Manidipine JDMF) empowers Manidipine 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 Manidipine JDMF during the approval evaluation for pharmaceutical products. At the time of Manidipine 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 Manidipine suppliers with JDMF on PharmaCompass.
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