01 1Kongo Chemical Co., Ltd.
02 3Sumitomo Chemical Co., Ltd.
01 1Disopyramide (production only)
02 1Disopyramide [CP]
03 1Japan Pharmaceutical Codex disopyramide phosphate
04 1Japanese Pharmacopoeia disopyramide
01 4Japan
Disopyramide (for manufacturing only)
Registration Number : 217MF11202
Registrant's Address : 3 Himata, Toyama City, Toyama Prefecture
Initial Date of Registration : 2005-12-12
Latest Date of Registration : 2007-02-13
Registration Number : 226MF10133
Registrant's Address : 2-27-1 Shinkawa, Chuo-ku, Tokyo
Initial Date of Registration : 2014-07-02
Latest Date of Registration : 2014-07-02
Japanese Pharmacopoeia Non-Drug Standard Disopyramide Phosphate
Registration Number : 217MF10097
Registrant's Address : 2-7-1 Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2005-05-23
Latest Date of Registration : 2007-09-06
Japanese Pharmacopoeia Disopyramide
Registration Number : 217MF10085
Registrant's Address : 2-27-1 Shinkawa, Chuo-ku, Tokyo
Initial Date of Registration : 2005-05-23
Latest Date of Registration : 2007-09-06
A Disopyramide Phosphate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Disopyramide Phosphate, including repackagers and relabelers. The FDA regulates Disopyramide Phosphate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Disopyramide Phosphate 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 Disopyramide Phosphate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Disopyramide Phosphate supplier is an individual or a company that provides Disopyramide Phosphate active pharmaceutical ingredient (API) or Disopyramide Phosphate finished formulations upon request. The Disopyramide Phosphate suppliers may include Disopyramide Phosphate API manufacturers, exporters, distributors and traders.
click here to find a list of Disopyramide Phosphate 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 Disopyramide Phosphate Drug Master File in Japan (Disopyramide Phosphate JDMF) empowers Disopyramide Phosphate 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 Disopyramide Phosphate JDMF during the approval evaluation for pharmaceutical products. At the time of Disopyramide Phosphate 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 Disopyramide Phosphate suppliers with JDMF on PharmaCompass.
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