SUPPLIERS
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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GDUFA
DMF Review : N/A
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DMF Number : 39484
Submission : 2024-01-31
Status : Active
Type : IV
GDUFA
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DMF Number : 37604
Submission : 2022-11-25
Status : Active
Type : IV
GDUFA
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DMF Number : 38022
Submission : 2023-04-11
Status : Active
Type : IV
GDUFA
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DMF Number : 40518
Submission : 2024-12-24
Status : Active
Type : IV
GDUFA
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DMF Number : 37932
Submission : 2023-06-06
Status : Active
Type : IV
GDUFA
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DMF Number : 24380
Submission : 2011-02-22
Status : Inactive
Type : IV
NDC Package Code : 42533-114
Start Marketing Date : 2009-11-16
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (23kg/23kg)
Marketing Category : BULK INGREDIENT
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FINISHED DOSAGE FORMULATIONS
EXCIPIENTS BY APPLICATIONS
Parenteral
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
Application : Parenteral
Excipient Details : Tris (hydroxymethyl) aminomethane is used in electrophoresis, protein purification, enzyme assay, and as a buffering agent in biologics production.
Pharmacopoeia Ref : USP, EP, BP, ChP
Technical Specs : Low Endotoxin, Low Metals
Ingredient(s) : Tromethamine
High-quality raw materials and custom blends for pharma, biopharma, nutrition, veterinary, and cosmetics worldwide.
Application : Parenteral
Excipient Details : Tris (hydroxymethyl) aminomethane is a buffering agent used in cell culture, downstream and biological formulations.
Pharmacopoeia Ref : On Request
Technical Specs : Low bacteria endotoxins, low bioburden (TAMC/TYMC). Customised pa...
Ingredient(s) : Tromethamine
Brand Name : Tromethamine (Tris)
Application : Parenteral
Excipient Details : It stabilizes the pH of solutions. It is also an enzyme inhibitor used in the biopharmaceutical industry.
Pharmacopoeia Ref : Not Available
Technical Specs : Bio Excipient Grade
Ingredient(s) : Tromethamine
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