01 1Lycored
01 1TOMATO OLEORESINS
01 1U.S.A
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33469
Submission : 2019-04-24
Status : Active
Type : II
A Lycopene manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lycopene, including repackagers and relabelers. The FDA regulates Lycopene manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lycopene 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 Lycopene manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lycopene supplier is an individual or a company that provides Lycopene active pharmaceutical ingredient (API) or Lycopene finished formulations upon request. The Lycopene suppliers may include Lycopene API manufacturers, exporters, distributors and traders.
click here to find a list of Lycopene suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lycopene DMF (Drug Master File) is a document detailing the whole manufacturing process of Lycopene active pharmaceutical ingredient (API) in detail. Different forms of Lycopene DMFs exist exist since differing nations have different regulations, such as Lycopene USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lycopene DMF submitted to regulatory agencies in the US is known as a USDMF. Lycopene USDMF includes data on Lycopene's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lycopene USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lycopene suppliers with USDMF on PharmaCompass.
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