Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
01 1Sanofi
02 1DAITO CORP
03 1Sekisui Medical Co. Ltd
01 2CLEMASTINE FUMERATE
02 1FUMARATE (30,356 R.P.)
01 1France
02 2Japan
01 1Active
02 2Inactive
01 1Complete
02 2Blank
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 : 3321
Submission : 1978-08-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6862
Submission : 1987-03-02
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-09-23
Pay. Date : 2020-09-18
DMF Number : 6877
Submission : 1987-03-06
Status : Active
Type : II
A Clemastine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Clemastine, including repackagers and relabelers. The FDA regulates Clemastine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Clemastine 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 Clemastine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Clemastine supplier is an individual or a company that provides Clemastine active pharmaceutical ingredient (API) or Clemastine finished formulations upon request. The Clemastine suppliers may include Clemastine API manufacturers, exporters, distributors and traders.
click here to find a list of Clemastine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Clemastine DMF (Drug Master File) is a document detailing the whole manufacturing process of Clemastine active pharmaceutical ingredient (API) in detail. Different forms of Clemastine DMFs exist exist since differing nations have different regulations, such as Clemastine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Clemastine DMF submitted to regulatory agencies in the US is known as a USDMF. Clemastine USDMF includes data on Clemastine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Clemastine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Clemastine suppliers with USDMF on PharmaCompass.
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