Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
01 1Sanofi
02 1Calyx Chemicals & Pharmaceuticals Limited
03 1Centaur Pharmaceuticals
04 1Industriale Chimica
05 1JIANGSU ZW PHARMACEUTICALS CO LTD
06 1Jubilant Generics
01 3ZOPICLONE
02 1ZOPICLONE (26,267 R.P.)
03 1ZOPICLONE API (EP) NON-STERILE DRUG SUBSTANCE
04 1ZOPICLONE E.P.
01 1China
02 1France
03 3India
04 1Italy
01 5Active
02 1Inactive
01 1Complete
02 5Blank
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3316
Submission : 1978-08-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15518
Submission : 2001-06-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21059
Submission : 2007-11-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-30
Pay. Date : 2013-04-17
DMF Number : 14661
Submission : 2000-01-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21622
Submission : 2008-04-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29169
Submission : 2015-03-30
Status : Active
Type : II
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.
A Zopiclone DMF (Drug Master File) is a document detailing the whole manufacturing process of Zopiclone active pharmaceutical ingredient (API) in detail. Different forms of Zopiclone DMFs exist exist since differing nations have different regulations, such as Zopiclone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Zopiclone DMF submitted to regulatory agencies in the US is known as a USDMF. Zopiclone USDMF includes data on Zopiclone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Zopiclone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Zopiclone suppliers with USDMF on PharmaCompass.
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