Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
01 1Pfanstiehl
02 1ANGUS Chemical Company
03 1Abbott Laboratories
04 1BioSpectra
05 1F. Hoffmann-La Roche
06 1SIGMA TAU
07 1Suzhou Yacoo Science
08 1The Mosaic Company
01 1China
02 1Switzerland
03 6U.S.A
01 1Active
02 5Inactive
03 2Blank
01 8Blank
01 8Blank
01 8Blank
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-07-10
Pay. Date : 2017-06-05
DMF Number : 31483
Submission : 2017-03-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 434
Submission : 1961-06-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12635
Submission : 1997-08-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3240
Submission : 1978-06-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10599
Submission : 1993-11-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4941
Submission : 1983-04-26
Status : Inactive
Type : II
A Tromethamine API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tromethamine API, including repackagers and relabelers. The FDA regulates Tromethamine API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tromethamine API 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 Tromethamine API supplier is an individual or a company that provides Tromethamine API active pharmaceutical ingredient (API) or Tromethamine API finished formulations upon request. The Tromethamine API suppliers may include Tromethamine API API manufacturers, exporters, distributors and traders.
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