01 1Edmond Pharma s. r. l.
02 1LABORATORI ALCHEMIA SRL
03 1Ohara Pharmaceutical Co., Ltd.
01 1MIDODRINE HYDROCHLORIDE
02 1Midodrine hydrochloride
03 1Outsiders regulations midodrine hydrochloride (production only)
01 1Italy
02 1Japan
03 1Sweden
Registration Number : 221MF10211
Registrant's Address : Via San Faustino, 68 20134 MILANO-Italy
Initial Date of Registration : 2009-09-28
Latest Date of Registration : 2016-10-21
Extramural regulations Midodrine hydrochloride (for manufacturing only)
Registration Number : 217MF11229
Registrant's Address : 121-15 Toriiino, Koka-cho, Koka City, Shiga Prefecture
Initial Date of Registration : 2005-12-12
Latest Date of Registration : 2008-10-10
Registration Number : 217MF10582
Registrant's Address : Strada Statale dei Giovi, 131-20037 Paderno Dugnano (MI) - Italy
Initial Date of Registration : 2005-09-14
Latest Date of Registration : 2021-02-19
A Midodrine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Midodrine, including repackagers and relabelers. The FDA regulates Midodrine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Midodrine 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 Midodrine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Midodrine supplier is an individual or a company that provides Midodrine active pharmaceutical ingredient (API) or Midodrine finished formulations upon request. The Midodrine suppliers may include Midodrine API manufacturers, exporters, distributors and traders.
click here to find a list of Midodrine 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 Midodrine Drug Master File in Japan (Midodrine JDMF) empowers Midodrine 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 Midodrine JDMF during the approval evaluation for pharmaceutical products. At the time of Midodrine 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 Midodrine suppliers with JDMF on PharmaCompass.
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