01 1Nanjing Baijingyu Pharmaceutical Co. , Ltd.
02 1Northeast Pharmaceutical Group Co. , Ltd.
03 2Yoshindo Co., Ltd.
04 1Zhejiang Apeloa Jiayuan Pharmaceutical Co. , Ltd.
01 2Chloramphenicol
02 1Chloramphenicol (N)
03 1Chloramphenicol (N) fines
04 1Chloramphenicol (production only)
01 3China
02 2Japan
Registration Number : 223MF10145
Registrant's Address : 8/F, Golden Eagle Han Zhong Garden, No. 1 Hanzhongmen street, Nanjing, China
Initial Date of Registration : 2011-09-30
Latest Date of Registration : 2011-09-30
Registration Number : 303MF10055
Registrant's Address : No. 8, Kunminghu Street, Economic & Technology Development District, Shenyang, China
Initial Date of Registration : 2021-03-30
Latest Date of Registration : 2021-03-30
Chloramphenicol (N) fine powder
Registration Number : 225MF10142
Registrant's Address : 3697-8 Hagishima, Fuchu-machi, Toyama City, Toyama Prefecture
Initial Date of Registration : 2013-07-23
Latest Date of Registration : 2022-06-28
Registration Number : 225MF10141
Registrant's Address : 3697-8 Hagishima, Fuchu-machi, Toyama City, Toyama Prefecture
Initial Date of Registration : 2013-07-23
Latest Date of Registration : 2022-06-28
Chloramphenicol (for manufacturing purposes only)
Registration Number : 219MF10197
Registrant's Address : Hengdian Industry Zone, Dongyang, Zhejiang 322118, China
Initial Date of Registration : 2007-06-08
Latest Date of Registration : 2009-02-02
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A Elase-Chloromycetin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Elase-Chloromycetin, including repackagers and relabelers. The FDA regulates Elase-Chloromycetin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Elase-Chloromycetin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Elase-Chloromycetin supplier is an individual or a company that provides Elase-Chloromycetin active pharmaceutical ingredient (API) or Elase-Chloromycetin finished formulations upon request. The Elase-Chloromycetin suppliers may include Elase-Chloromycetin API manufacturers, exporters, distributors and traders.
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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 Elase-Chloromycetin Drug Master File in Japan (Elase-Chloromycetin JDMF) empowers Elase-Chloromycetin 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 Elase-Chloromycetin JDMF during the approval evaluation for pharmaceutical products. At the time of Elase-Chloromycetin JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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