01 2ACE Japan Co Ltd
02 1Astellas Pharma
03 1Katsura Chemical
01 4Japan
01 1Inactive
02 3Blank
01 4Blank
01 1217MF10135
02 1219MF10155
03 1221MF10140
04 1Blank
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10116
Submission : 1993-03-03
Status : Inactive
Type : II
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 : --
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 : --
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 : --
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.
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