01 1FORMOSA LABORATORIES, INC.
02 1Kyongbo Pharmaceutical Co. , Ltd.
03 1Shiratori Pharmaceutical Co., Ltd.
04 1Sumitomo Chemical Co., Ltd.
01 3Oteracil potassium
02 1Oteracil potassium production dedicated
01 2Japan
02 1South Korea
03 1Taiwan
Registration Number : 224MF10134
Registrant's Address : 36 Hoping Street, Louchu, Taoyuan 33842, Taiwan
Initial Date of Registration : 2012-07-19
Latest Date of Registration : 2013-05-22
Registration Number : 224MF10034
Registrant's Address : 174, Sirok-ro, Asan-si, Chungcheongnam-do, KOREA
Initial Date of Registration : 2012-02-15
Latest Date of Registration : 2012-02-15
Oteracil potassium for manufacturing purposes only
Registration Number : 225MF10004
Registrant's Address : 6-11-24 Tsudanuma, Narashino City, Chiba Prefecture
Initial Date of Registration : 2013-01-18
Latest Date of Registration : 2013-01-18
Registration Number : 219MF10375
Registrant's Address : 2-7-1 Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2007-12-19
Latest Date of Registration : 2007-12-19
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PharmaCompass offers a list of Oteracil Potassium API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Oteracil Potassium manufacturer or Oteracil Potassium supplier for your needs.
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A Potassium otastat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Potassium otastat, including repackagers and relabelers. The FDA regulates Potassium otastat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Potassium otastat 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 Potassium otastat manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Potassium otastat supplier is an individual or a company that provides Potassium otastat active pharmaceutical ingredient (API) or Potassium otastat finished formulations upon request. The Potassium otastat suppliers may include Potassium otastat API manufacturers, exporters, distributors and traders.
click here to find a list of Potassium otastat suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 Potassium otastat Drug Master File in Japan (Potassium otastat JDMF) empowers Potassium otastat 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 Potassium otastat JDMF during the approval evaluation for pharmaceutical products. At the time of Potassium otastat 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 Potassium otastat suppliers with JDMF on PharmaCompass.
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