01 2CULTOR FOOD SCIENCE INC
02 1Inalco SpA
03 1Particle Dynamics International, LLC.
01 1DESTAB™ LACTITOL
02 2LACTITOL MONOHYDRATE
03 1LACTITOL, DIRECTLY COMPRESSIBLE FORM,(FINLAC DC)
01 1Italy
02 3U.S.A
01 2Active
02 2Inactive
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13970
Submission : 1998-12-04
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13952
Submission : 1998-12-04
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27765
Submission : 2013-11-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31871
Submission : 2017-09-18
Status : Active
Type : II
A Lactitol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lactitol, including repackagers and relabelers. The FDA regulates Lactitol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lactitol 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 Lactitol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lactitol supplier is an individual or a company that provides Lactitol active pharmaceutical ingredient (API) or Lactitol finished formulations upon request. The Lactitol suppliers may include Lactitol API manufacturers, exporters, distributors and traders.
click here to find a list of Lactitol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lactitol DMF (Drug Master File) is a document detailing the whole manufacturing process of Lactitol active pharmaceutical ingredient (API) in detail. Different forms of Lactitol DMFs exist exist since differing nations have different regulations, such as Lactitol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lactitol DMF submitted to regulatory agencies in the US is known as a USDMF. Lactitol USDMF includes data on Lactitol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lactitol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lactitol suppliers with USDMF on PharmaCompass.
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