01 1Active Pharma Co., Ltd.
02 3CENTAUR PHARMACEUTICALS PRIVATE LTD.
03 1INDUSTRIALE CHIMICA s. r. l.
01 1ZOPICLONE
02 1ZOPICLONE EP
03 2Zopiclone
04 1Zopiclone (production only)
01 3India
02 1Italy
03 1Japan
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 : 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 : 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 Jimbocho, Chiyoda-ku, Tokyo
Initial Date of Registration : 2006-03-17
Latest Date of Registration : 2006-03-17
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PharmaCompass offers a list of Zopiclone API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Zopiclone manufacturer or Zopiclone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Zopiclone manufacturer or Zopiclone supplier.
A ES-ZOPICLONE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ES-ZOPICLONE, including repackagers and relabelers. The FDA regulates ES-ZOPICLONE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ES-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 ES-ZOPICLONE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A ES-ZOPICLONE supplier is an individual or a company that provides ES-ZOPICLONE active pharmaceutical ingredient (API) or ES-ZOPICLONE finished formulations upon request. The ES-ZOPICLONE suppliers may include ES-ZOPICLONE API manufacturers, exporters, distributors and traders.
click here to find a list of ES-ZOPICLONE suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 ES-ZOPICLONE Drug Master File in Japan (ES-ZOPICLONE JDMF) empowers ES-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 ES-ZOPICLONE JDMF during the approval evaluation for pharmaceutical products. At the time of ES-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 ES-ZOPICLONE suppliers with JDMF on PharmaCompass.
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