01 1Heraeus Holding
02 1Juzen Chemical Corporation
03 1Midas Pharma
04 1Nippon Rikagaku Yakuhin
01 25-AMINOLEVULINIC ACID HYDROCHLORIDE
02 15-AMINOLEVULINIC ACID HYDROCHLORIDE DRUG SUBSTANCE
03 1STUDY RESIDUE PROBLS RELATED TO U/OF EXPERIMENTAL ORGANOPHOSPHORUS COM
01 2Germany
02 2Japan
01 2Active
02 2Inactive
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24359
Submission : 2010-11-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17844
Submission : 2004-11-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29376
Submission : 2015-05-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23711
Submission : 2010-04-06
Status : Inactive
Type : II
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PharmaCompass offers a list of Aminolevulinic Acid HCl API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Aminolevulinic Acid HCl manufacturer or Aminolevulinic Acid HCl supplier for your needs.
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A Levulan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Levulan, including repackagers and relabelers. The FDA regulates Levulan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Levulan 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 Levulan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Levulan supplier is an individual or a company that provides Levulan active pharmaceutical ingredient (API) or Levulan finished formulations upon request. The Levulan suppliers may include Levulan API manufacturers, exporters, distributors and traders.
click here to find a list of Levulan suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Levulan DMF (Drug Master File) is a document detailing the whole manufacturing process of Levulan active pharmaceutical ingredient (API) in detail. Different forms of Levulan DMFs exist exist since differing nations have different regulations, such as Levulan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Levulan DMF submitted to regulatory agencies in the US is known as a USDMF. Levulan USDMF includes data on Levulan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Levulan USDMF is kept confidential to protect the manufacturer’s intellectual property.
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