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 : 39484
Submission : 2024-01-31
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40518
Submission : 2024-12-24
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37932
Submission : 2023-06-06
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37604
Submission : 2022-11-25
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38022
Submission : 2023-04-11
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
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
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 : 39484
Submission : 2024-01-31
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38022
Submission : 2023-04-11
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37604
Submission : 2022-11-25
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24380
Submission : 2011-02-22
Status : Inactive
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37932
Submission : 2023-06-06
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40518
Submission : 2024-12-24
Status : Active
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
FINISHED DOSAGE FORMULATIONS
Drug : BORTEZOMIB
Dosage Form : POWDER; INTRAVENOUS
Application Number : 206927
Country : US
Patented : No
Drug : URSODIOL
Dosage Form : TABLET; ORAL
Application Number : 213504
Country : US
Patented : No
CLINDAMYCIN PHOSPHATE; TRETINOIN
Drug : CLINDAMYCIN PHOSPHATE AND TRETINOIN
Dosage Form : GEL; TOPICAL
Application Number : 202564
Country : US
Patented : No
CLINDAMYCIN PHOSPHATE; TRETINOIN
Drug : VELTIN
Dosage Form : GEL; TOPICAL
Application Number : 50803
Country : US
Patented : No
Drug : FOSPHENYTOIN SODIUM
Dosage Form : INJECTABLE; INJECTION
Application Number : 78277
Country : US
Patented : No
Drug : TIMOPTIC-XE
Dosage Form : SOLUTION, GEL FORMING/DROPS; OPHTHALMIC
Application Number : 20330
Country : US
Patented : No
Drug : ISOVUE-200
Dosage Form : INJECTABLE; INJECTION
Application Number : 20327
Country : US
Patented : No
Drug : ISOVUE-300
Dosage Form : INJECTABLE; INJECTION
Application Number : 18735
Country : US
Patented : No
Drug : ISOVUE-M 200
Dosage Form : INJECTABLE; INJECTION
Application Number : 18735
Country : US
Patented : No
Drug : ISOVUE-250
Dosage Form : INJECTABLE; INJECTION
Application Number : 18735
Country : US
Patented : No
EXCIPIENTS BY APPLICATIONS
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 : pH: 7 and 9
Ingredient(s) : Tris hydroxymethyl aminomethane
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
Brand Name : Tromethamine (Tris)
Application : Topical
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
https://www.pharmacompass.com/radio-compass-blog/excipient-market-overview-roquette-seqens-evonik-make-strategic-moves-new-guidelines-deal-with-contamination
30 Jan 2025
// BUSINESSWIRE
MARKET PLACE
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18 Aug 2023
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04 Sep 2020
REF. STANDARDS & IMPURITIES