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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 261
Submission : 1957-05-15
Status : Inactive
Type : II
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A Squalane manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Squalane, including repackagers and relabelers. The FDA regulates Squalane manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Squalane 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 Squalane manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Squalane supplier is an individual or a company that provides Squalane active pharmaceutical ingredient (API) or Squalane finished formulations upon request. The Squalane suppliers may include Squalane API manufacturers, exporters, distributors and traders.
click here to find a list of Squalane suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Squalane DMF (Drug Master File) is a document detailing the whole manufacturing process of Squalane active pharmaceutical ingredient (API) in detail. Different forms of Squalane DMFs exist exist since differing nations have different regulations, such as Squalane USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Squalane DMF submitted to regulatory agencies in the US is known as a USDMF. Squalane USDMF includes data on Squalane's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Squalane USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Squalane suppliers with USDMF on PharmaCompass.
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