01 1Active Pharma Inc.
02 1Glenmark Life Sciences Limited
03 1TAPI Croatia Industries Ltd.
01 2Eszopiclone
02 1Eszopiclone "Teva / PLIVA"
01 1Croatia
02 1India
03 1Japan
Registration Number : 301MF10099
Registrant's Address : 2-36-1 Kanda Jinbocho, Chiyoda-ku, Tokyo
Initial Date of Registration : 2019-11-27
Latest Date of Registration : 2019-11-27
Registration Number : 302MF10028
Registrant's Address : 4th Floor, OIA House, 470, Cardinal Gracious Road, Andheri East Mumbai 400099, Mahara...
Initial Date of Registration : 2020-02-13
Latest Date of Registration : 2020-02-13
Registration Number : 228MF10074
Registrant's Address : Prudnicka cesta 54, Savski Marof, County Brdovec 10291 Prigorje Brdovecko, Croatia
Initial Date of Registration : 2016-03-24
Latest Date of Registration : 2022-12-07
A Eszopiclone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eszopiclone, including repackagers and relabelers. The FDA regulates Eszopiclone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eszopiclone 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 Eszopiclone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Eszopiclone supplier is an individual or a company that provides Eszopiclone active pharmaceutical ingredient (API) or Eszopiclone finished formulations upon request. The Eszopiclone suppliers may include Eszopiclone API manufacturers, exporters, distributors and traders.
click here to find a list of Eszopiclone 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 Eszopiclone Drug Master File in Japan (Eszopiclone JDMF) empowers Eszopiclone 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 Eszopiclone JDMF during the approval evaluation for pharmaceutical products. At the time of Eszopiclone 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 Eszopiclone suppliers with JDMF on PharmaCompass.
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