Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
01 1Sanofi
02 1Blank
01 1ISOETHARINE MESYLATE AND ISOETHARINE HYDROCHLORIDE
02 1ISOETHARINE SALTS INCLUDING ISOETHARINE MESYLATE
01 1France
02 1Blank
01 2Inactive
01 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 : 11089
Submission : 1994-09-16
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1938
Submission : 1972-05-17
Status : Inactive
Type : II
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A Isoetharine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isoetharine, including repackagers and relabelers. The FDA regulates Isoetharine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isoetharine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Isoetharine supplier is an individual or a company that provides Isoetharine active pharmaceutical ingredient (API) or Isoetharine finished formulations upon request. The Isoetharine suppliers may include Isoetharine API manufacturers, exporters, distributors and traders.
click here to find a list of Isoetharine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Isoetharine DMF (Drug Master File) is a document detailing the whole manufacturing process of Isoetharine active pharmaceutical ingredient (API) in detail. Different forms of Isoetharine DMFs exist exist since differing nations have different regulations, such as Isoetharine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Isoetharine DMF submitted to regulatory agencies in the US is known as a USDMF. Isoetharine USDMF includes data on Isoetharine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Isoetharine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Isoetharine suppliers with USDMF on PharmaCompass.
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