Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
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01 1Pfanstiehl
02 1Anmol Chemicals
03 1Corbion
04 1Galactic
05 1Luoyang Longmen Pharmaceutical
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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
05 1SODIUM LACTATE SOLUTION BP
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01 1Belgium
02 1China
03 1India
04 1Netherlands
05 1U.S.A
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01 5Active
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01 2Complete
02 3Blank
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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 40912
Submission : 2025-01-09
Status : Active
Type : IV
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
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A Sodium lactate 0.167 molar in plastic container manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium lactate 0.167 molar in plastic container, including repackagers and relabelers. The FDA regulates Sodium lactate 0.167 molar in plastic container manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium lactate 0.167 molar in plastic container 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 Sodium lactate 0.167 molar in plastic container DMF (Drug Master File) is a document detailing the whole manufacturing process of Sodium lactate 0.167 molar in plastic container active pharmaceutical ingredient (API) in detail. Different forms of Sodium lactate 0.167 molar in plastic container DMFs exist exist since differing nations have different regulations, such as Sodium lactate 0.167 molar in plastic container USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sodium lactate 0.167 molar in plastic container DMF submitted to regulatory agencies in the US is known as a USDMF. Sodium lactate 0.167 molar in plastic container USDMF includes data on Sodium lactate 0.167 molar in plastic container's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sodium lactate 0.167 molar in plastic container USDMF is kept confidential to protect the manufacturer’s intellectual property.
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