01 2Ace Japan Co., Ltd.
02 1Katsura Chemical Co., Ltd.
01 3Zotepine
01 3Japan
Registration Number : 221MF10140
Registrant's Address : 5850-1 Higashine-ko, Higashine City, Yamagata Prefecture
Initial Date of Registration : 2009-07-09
Latest Date of Registration : 2009-07-09
Registration Number : 217MF10135
Registrant's Address : 5850-1 Higashine-ko, Higashine City, Yamagata Prefecture
Initial Date of Registration : 2005-05-24
Latest Date of Registration : 2006-06-09
Registration Number : 219MF10155
Registrant's Address : 4-15-19 Hibarigaoka, Zama City, Kanagawa Prefecture
Initial Date of Registration : 2007-04-27
Latest Date of Registration : 2007-04-27
A Zotepine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zotepine, including repackagers and relabelers. The FDA regulates Zotepine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zotepine 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 Zotepine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Zotepine supplier is an individual or a company that provides Zotepine active pharmaceutical ingredient (API) or Zotepine finished formulations upon request. The Zotepine suppliers may include Zotepine API manufacturers, exporters, distributors and traders.
click here to find a list of Zotepine 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 Zotepine Drug Master File in Japan (Zotepine JDMF) empowers Zotepine 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 Zotepine JDMF during the approval evaluation for pharmaceutical products. At the time of Zotepine 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 Zotepine suppliers with JDMF on PharmaCompass.
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