Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
01 1Sanofi
02 1OLTA PHARMACEUTICALS CORP
01 1LINDANE
02 1LINDANE, USP
01 1France
02 1U.S.A
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 : 8167
Submission : 1989-08-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22259
Submission : 2009-01-08
Status : Inactive
Type : II
A Lindane manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lindane, including repackagers and relabelers. The FDA regulates Lindane manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lindane 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 Lindane supplier is an individual or a company that provides Lindane active pharmaceutical ingredient (API) or Lindane finished formulations upon request. The Lindane suppliers may include Lindane API manufacturers, exporters, distributors and traders.
click here to find a list of Lindane suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lindane DMF (Drug Master File) is a document detailing the whole manufacturing process of Lindane active pharmaceutical ingredient (API) in detail. Different forms of Lindane DMFs exist exist since differing nations have different regulations, such as Lindane USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lindane DMF submitted to regulatory agencies in the US is known as a USDMF. Lindane USDMF includes data on Lindane's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lindane USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lindane suppliers with USDMF on PharmaCompass.
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