Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
01 1Pfanstiehl
02 1Corbion
03 1Galactic
04 1Luoyang Longmen Pharmaceutical
01 1SODIUM (S)-LACTATE SOLUTION
02 1SODIUM (S)-LACTATE SOLUTION 50%, 60% SODIUM LACTATE CONTENT
03 1SODIUM DL-LACTATE SOLUTION 60%, USP (S-110, S110-M)
04 1SODIUM LACTATE SOLUTION
01 1Belgium
02 1China
03 1Netherlands
04 1U.S.A
01 4Active
01 2Complete
02 2Blank
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7658
Submission : 1988-09-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-28
Pay. Date : 2017-03-17
DMF Number : 20598
Submission : 2007-06-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-09-26
Pay. Date : 2016-07-25
DMF Number : 30736
Submission : 2016-07-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35258
Submission : 2020-09-26
Status : Active
Type : II
100
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A DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER-4 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER-4, including repackagers and relabelers. The FDA regulates DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER-4 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER-4 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER-4 DMF (Drug Master File) is a document detailing the whole manufacturing process of DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER-4 active pharmaceutical ingredient (API) in detail. Different forms of DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER-4 DMFs exist exist since differing nations have different regulations, such as DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER-4 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER-4 DMF submitted to regulatory agencies in the US is known as a USDMF. DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER-4 USDMF includes data on DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER-4's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER-4 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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We have 4 companies offering DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER-4
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