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 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
A Oteracil Potassium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oteracil Potassium, including repackagers and relabelers. The FDA regulates Oteracil Potassium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oteracil Potassium 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 Oteracil Potassium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Oteracil Potassium supplier is an individual or a company that provides Oteracil Potassium active pharmaceutical ingredient (API) or Oteracil Potassium finished formulations upon request. The Oteracil Potassium suppliers may include Oteracil Potassium API manufacturers, exporters, distributors and traders.
click here to find a list of Oteracil Potassium 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 Oteracil Potassium Drug Master File in Japan (Oteracil Potassium JDMF) empowers Oteracil Potassium 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 Oteracil Potassium JDMF during the approval evaluation for pharmaceutical products. At the time of Oteracil Potassium 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 Oteracil Potassium suppliers with JDMF on PharmaCompass.
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