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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PharmaCompass offers a list of Lutein API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Lutein manufacturer or Lutein supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lutein manufacturer or Lutein supplier.
PharmaCompass also assists you with knowing the Lutein API Price utilized in the formulation of products. Lutein API Price is not always fixed or binding as the Lutein Price is obtained through a variety of data sources. The Lutein Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Lutein manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lutein, including repackagers and relabelers. The FDA regulates Lutein manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lutein 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 Lutein manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lutein supplier is an individual or a company that provides Lutein active pharmaceutical ingredient (API) or Lutein finished formulations upon request. The Lutein suppliers may include Lutein API manufacturers, exporters, distributors and traders.
click here to find a list of Lutein suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lutein DMF (Drug Master File) is a document detailing the whole manufacturing process of Lutein active pharmaceutical ingredient (API) in detail. Different forms of Lutein DMFs exist exist since differing nations have different regulations, such as Lutein USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lutein DMF submitted to regulatory agencies in the US is known as a USDMF. Lutein USDMF includes data on Lutein's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lutein USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lutein suppliers with USDMF on PharmaCompass.
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