01 1Lonza Group
01 1CN 28091 LACTOL-LACTAM
01 1Switzerland
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15740
Submission : 2001-11-15
Status : Inactive
Type : II
A Luteolin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Luteolin, including repackagers and relabelers. The FDA regulates Luteolin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Luteolin 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 Luteolin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Luteolin supplier is an individual or a company that provides Luteolin active pharmaceutical ingredient (API) or Luteolin finished formulations upon request. The Luteolin suppliers may include Luteolin API manufacturers, exporters, distributors and traders.
click here to find a list of Luteolin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Luteolin DMF (Drug Master File) is a document detailing the whole manufacturing process of Luteolin active pharmaceutical ingredient (API) in detail. Different forms of Luteolin DMFs exist exist since differing nations have different regulations, such as Luteolin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Luteolin DMF submitted to regulatory agencies in the US is known as a USDMF. Luteolin USDMF includes data on Luteolin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Luteolin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Luteolin suppliers with USDMF on PharmaCompass.
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