01 1DONGBANG FUTURE TECH & LIFE CO. , LTD.
02 1Daito Co., Ltd.
03 1Dipharma Francis S. r. l.
04 1JEIL PHARMACEUTICAL CO. , LTD.
05 1Shiratori Pharmaceutical Co., Ltd.
06 1UBE Inc.
01 4Azelnidipine
02 1Azelnidipine production dedicated
03 1Calblock
01 1Italy
02 3Japan
03 2South Korea
Registration Number : 224MF10050
Registrant's Address : 326 Yokamachi, Toyama City, Toyama Prefecture
Initial Date of Registration : 2012-03-12
Latest Date of Registration : 2012-03-12
Registration Number : 225MF10158
Registrant's Address : Via Bissone, 5, 20021-Baranzate, Milano, Italy
Initial Date of Registration : 2013-08-14
Latest Date of Registration : 2013-08-14
Registration Number : 231MF10056
Registrant's Address : 78, Jeyakgongdan 4-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do, Korea
Initial Date of Registration : 2019-02-25
Latest Date of Registration : 2019-02-25
Registration Number : 229MF10077
Registrant's Address : 343, Sapyeong-daero, Seocho-gu, Seoul, Korea
Initial Date of Registration : 2017-04-11
Latest Date of Registration : 2022-07-27
Azelnidipine For manufacturing purposes only
Registration Number : 224MF10038
Registrant's Address : 6-11-24 Tsudanuma, Narashino City, Chiba Prefecture
Initial Date of Registration : 2012-02-23
Latest Date of Registration : 2012-02-23
Registration Number : 217MF10445
Registrant's Address : 1978-96 Ogushi, Ube City, Yamaguchi Prefecture
Initial Date of Registration : 2005-08-19
Latest Date of Registration : 2008-04-15
A Azelnidipine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Azelnidipine, including repackagers and relabelers. The FDA regulates Azelnidipine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Azelnidipine 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 Azelnidipine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Azelnidipine supplier is an individual or a company that provides Azelnidipine active pharmaceutical ingredient (API) or Azelnidipine finished formulations upon request. The Azelnidipine suppliers may include Azelnidipine API manufacturers, exporters, distributors and traders.
click here to find a list of Azelnidipine 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 Azelnidipine Drug Master File in Japan (Azelnidipine JDMF) empowers Azelnidipine 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 Azelnidipine JDMF during the approval evaluation for pharmaceutical products. At the time of Azelnidipine 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 Azelnidipine suppliers with JDMF on PharmaCompass.
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