01 1Abbott Laboratories
02 2DANIPHARM A S
03 4Fresenius Kabi Austria
04 4Inalco SpA
05 1Lactose India Limited
06 1RELAX LTD
07 3SOLVAY -Technology Solutions
08 1Syngars Technology
09 1Zambon Switzerland
10 2Blank
01 2LACTULOSE
02 1LACTULOSE 50% SYRUP
03 2LACTULOSE CONCENTRATE
04 1LACTULOSE CONCENTRATE (BULK)
05 4LACTULOSE CONCENTRATE USP
06 1LACTULOSE CRYSTALLINE
07 3LACTULOSE CRYSTALS
08 1LACTULOSE PURUM LIQUIDUM
09 1LACTULOSE SOLUTION
10 2LACTULOSE SOLUTION USP
11 1LACTULOSE SYRUP (MLS-50)
12 1PURIFIED LACTULOSE SYRUP
01 4Austria
02 1China
03 2Denmark
04 3Germany
05 1India
06 4Italy
07 1Malta
08 1Switzerland
09 1U.S.A
10 2Blank
01 9Active
02 11Inactive
01 5Complete
02 15Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10145
Submission : 1993-03-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-28
Pay. Date : 2016-09-30
DMF Number : 8760
Submission : 1990-09-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-09-09
Pay. Date : 2014-12-12
DMF Number : 15253
Submission : 2001-02-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-22
Pay. Date : 2017-01-23
DMF Number : 20562
Submission : 2007-05-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-06-25
Pay. Date : 2012-11-28
DMF Number : 15254
Submission : 2001-02-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5412
Submission : 1984-02-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39039
Submission : 2024-01-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-15
Pay. Date : 2013-03-04
DMF Number : 8195
Submission : 1989-09-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 835
Submission : 1964-09-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38252
Submission : 2023-03-28
Status : Active
Type : II
A Lactulose manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lactulose, including repackagers and relabelers. The FDA regulates Lactulose manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lactulose 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 Lactulose manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lactulose supplier is an individual or a company that provides Lactulose active pharmaceutical ingredient (API) or Lactulose finished formulations upon request. The Lactulose suppliers may include Lactulose API manufacturers, exporters, distributors and traders.
click here to find a list of Lactulose suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lactulose DMF (Drug Master File) is a document detailing the whole manufacturing process of Lactulose active pharmaceutical ingredient (API) in detail. Different forms of Lactulose DMFs exist exist since differing nations have different regulations, such as Lactulose USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lactulose DMF submitted to regulatory agencies in the US is known as a USDMF. Lactulose USDMF includes data on Lactulose's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lactulose USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lactulose suppliers with USDMF on PharmaCompass.
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