01 1ALP Pharm
02 1Sunpure Extracts
01 1LUTEIN (DRUG SUBSTANCE, NON-STERILE)
02 1LUTEIN POWDER 20% (ZEAXANTHIN 4%)
01 1China
02 1India
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22151
Submission : 2008-10-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35936
Submission : 2021-05-18
Status : Active
Type : II
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A XANTHOPHYLL manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of XANTHOPHYLL, including repackagers and relabelers. The FDA regulates XANTHOPHYLL manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. XANTHOPHYLL 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 XANTHOPHYLL manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A XANTHOPHYLL supplier is an individual or a company that provides XANTHOPHYLL active pharmaceutical ingredient (API) or XANTHOPHYLL finished formulations upon request. The XANTHOPHYLL suppliers may include XANTHOPHYLL API manufacturers, exporters, distributors and traders.
click here to find a list of XANTHOPHYLL suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A XANTHOPHYLL DMF (Drug Master File) is a document detailing the whole manufacturing process of XANTHOPHYLL active pharmaceutical ingredient (API) in detail. Different forms of XANTHOPHYLL DMFs exist exist since differing nations have different regulations, such as XANTHOPHYLL USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A XANTHOPHYLL DMF submitted to regulatory agencies in the US is known as a USDMF. XANTHOPHYLL USDMF includes data on XANTHOPHYLL's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The XANTHOPHYLL USDMF is kept confidential to protect the manufacturer’s intellectual property.
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