01 1Hamari PFST Co., Ltd.
02 1Ohara Pharmaceutical Co., Ltd.
03 1Pen Tsao Chemical Industry Ltd.
04 1Yonezawa Hamari Pharmaceuticals Co., Ltd.
01 1Bucillamine "hamari Y"
02 1Japanese Pharmacopoeia bucillamine
03 1Japanese Pharmacopoeia bucillamine "D" (production only)
04 1Outsiders regulations bucillamine (production only)
01 1China
02 3Japan
Japanese Pharmacopoeia Bucillamine "D" (for manufacturing only)
Registration Number : 221MF10273
Registrant's Address : 121-15 Toriiino, Koka-cho, Koka City, Shiga Prefecture
Initial Date of Registration : 2009-12-09
Latest Date of Registration : 2014-11-17
Japanese Pharmacopoeia Bucillamine
Registration Number : 219MF10275
Registrant's Address : 27B, CKK Comm Center, 289 Hennessy Road, Wanchai, Hong Kong SAR, China
Initial Date of Registration : 2007-09-04
Latest Date of Registration : 2007-09-04
Registration Number : 222MF10135
Registrant's Address : Osaka Prefecture, Osaka City, Suminoe Ward, Nanko Kita 1-19-40
Initial Date of Registration : 2010-04-13
Latest Date of Registration : 2010-04-13
Extramural regulation Bucillamine (for manufacturing only)
Registration Number : 217MF10858
Registrant's Address : 18-4300 Yahatahara 2-chome, Yonezawa City, Yamagata Prefecture
Initial Date of Registration : 2005-11-01
Latest Date of Registration : 2010-02-25
A Bucillamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bucillamine, including repackagers and relabelers. The FDA regulates Bucillamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bucillamine 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 Bucillamine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bucillamine supplier is an individual or a company that provides Bucillamine active pharmaceutical ingredient (API) or Bucillamine finished formulations upon request. The Bucillamine suppliers may include Bucillamine API manufacturers, exporters, distributors and traders.
click here to find a list of Bucillamine 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 Bucillamine Drug Master File in Japan (Bucillamine JDMF) empowers Bucillamine 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 Bucillamine JDMF during the approval evaluation for pharmaceutical products. At the time of Bucillamine 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 Bucillamine suppliers with JDMF on PharmaCompass.
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