01 1Permakem Asia Co., Ltd.
02 1Sanyo Fine Co., Ltd.
03 1Yamamoto Chemical Industry Co., Ltd.
01 3Actarit
01 1Gabon
02 2Japan
Registration Number : 220MF10134
Registrant's Address : 1-10-11, Nihonbashi Horidomecho, Chuo-ku, Tokyo
Initial Date of Registration : 2008-05-29
Latest Date of Registration : 2008-05-29
Registration Number : 301MF10108
Registrant's Address : Osaka Prefecture, Osaka City, Nishi Ward, Awaza 1-12-18
Initial Date of Registration : 2019-12-10
Latest Date of Registration : 2019-12-10
Registration Number : 217MF10566
Registrant's Address : 1-4 Funatsucho, Wakayama City, Wakayama Prefecture
Initial Date of Registration : 2005-09-09
Latest Date of Registration : 2007-12-19
A Actarit manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Actarit, including repackagers and relabelers. The FDA regulates Actarit manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Actarit API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Actarit supplier is an individual or a company that provides Actarit active pharmaceutical ingredient (API) or Actarit finished formulations upon request. The Actarit suppliers may include Actarit API manufacturers, exporters, distributors and traders.
click here to find a list of Actarit 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 Actarit Drug Master File in Japan (Actarit JDMF) empowers Actarit 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 Actarit JDMF during the approval evaluation for pharmaceutical products. At the time of Actarit 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 Actarit suppliers with JDMF on PharmaCompass.
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