01 1Active Pharma Inc.
02 3CENTAUR PHARMACEUTICALS PRIVATE LTD.
03 1INDUSTRIALE CHIMICA s. r. l.
04 1Sanyo Chemical Research Institute Co., Ltd.
01 1ZOPICLONE
02 1ZOPICLONE EP
03 3Zopiclone
04 1Zopiclone (production only)
01 1Gabon
02 3India
03 1Italy
04 1Japan
Registration Number : 221MF10175
Registrant's Address : “CENTAUR HOUSE”, NEAR GRAND HYATT, SHANTI NAGAR, VAKOLA, SANTACRUZ (EAST), MUMBAI...
Initial Date of Registration : 2009-08-07
Latest Date of Registration : 2009-08-07
Zopiclone (for manufacturing purposes only)
Registration Number : 221MF10174
Registrant's Address : “CENTAUR HOUSE”, NEAR GRAND HYATT, SHANTI NAGAR, VAKOLA, SANTACRUZ (EAST), MUMBAI...
Initial Date of Registration : 2009-08-07
Latest Date of Registration : 2009-08-07
Registration Number : 224MF10202
Registrant's Address : “CENTAUR HOUSE”, NEAR GRAND HYATT, SHANTI NAGAR, VAKOLA, SANTACRUZ (EAST), MUMBAI...
Initial Date of Registration : 2012-10-09
Latest Date of Registration : 2012-10-09
Registration Number : 220MF10114
Registrant's Address : Via E. H. Grieg, 13,21047 Saronno (VARESE) ITALY
Initial Date of Registration : 2008-04-21
Latest Date of Registration : 2017-01-23
Registration Number : 218MF10351
Registrant's Address : 2-36-1 Kanda Jinbocho, Chiyoda-ku, Tokyo
Initial Date of Registration : 2006-03-17
Latest Date of Registration : 2006-03-17
Registration Number : 217MF10148
Registrant's Address : 148-1 Tajii, Mihara-ku, Sakai City, Osaka Prefecture
Initial Date of Registration : 2005-05-31
Latest Date of Registration : 2007-01-10
A Zopiclone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zopiclone, including repackagers and relabelers. The FDA regulates Zopiclone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zopiclone 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 Zopiclone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Zopiclone supplier is an individual or a company that provides Zopiclone active pharmaceutical ingredient (API) or Zopiclone finished formulations upon request. The Zopiclone suppliers may include Zopiclone API manufacturers, exporters, distributors and traders.
click here to find a list of Zopiclone 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 Zopiclone Drug Master File in Japan (Zopiclone JDMF) empowers Zopiclone 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 Zopiclone JDMF during the approval evaluation for pharmaceutical products. At the time of Zopiclone 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 Zopiclone suppliers with JDMF on PharmaCompass.
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