01 1Delta Synthetic Co. , Ltd.
02 1Hamari PFST Co., Ltd.
03 1Yamamoto Chemical Industry Co., Ltd.
01 1Japanese Pharmacopoeia guaifenesin
02 2Japanese Pharmacopoeia guaifenesin (production only)
01 2Japan
02 1Taiwan
Japanese Pharmacopoeia Guaifenesin (for manufacturing only)
Registration Number : 218MF10772
Registrant's Address : 15, Minsheng St. , Tucheng Dist. , New Taipei City 23679, Taiwan (R.O.C.)
Initial Date of Registration : 2006-09-22
Latest Date of Registration : 2016-01-08
Japanese Pharmacopoeia Guaifenesin
Registration Number : 217MF10558
Registrant's Address : 1-4 Funatsucho, Wakayama City, Wakayama Prefecture
Initial Date of Registration : 2005-09-09
Latest Date of Registration : 2007-12-13
Japanese Pharmacopoeia Guaifenesin (for manufacturing only)
Registration Number : 217MF10885
Registrant's Address : Osaka Prefecture, Osaka City, Suminoe Ward, Nanko Kita 1-19-40
Initial Date of Registration : 2005-11-07
Latest Date of Registration : 2010-02-16
A Oresol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oresol, including repackagers and relabelers. The FDA regulates Oresol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oresol 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 Oresol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Oresol supplier is an individual or a company that provides Oresol active pharmaceutical ingredient (API) or Oresol finished formulations upon request. The Oresol suppliers may include Oresol API manufacturers, exporters, distributors and traders.
click here to find a list of Oresol 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 Oresol Drug Master File in Japan (Oresol JDMF) empowers Oresol 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 Oresol JDMF during the approval evaluation for pharmaceutical products. At the time of Oresol 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 Oresol suppliers with JDMF on PharmaCompass.
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