GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16037
Submission : 2002-07-03
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41204
Submission : 2025-01-15
Status : Active
Type : IV
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 :
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DMF Number : 32464
Submission : 2018-02-15
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17044
Submission : 2003-12-22
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24099
Submission : 2010-08-27
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28402
Submission : 2014-06-18
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39035
Submission : 2023-10-27
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20960
Submission : 2007-10-11
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41812
Submission : 2025-07-25
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41483
Submission : 2025-03-21
Status : Active
Type : IV

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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Mannitol, For Use In The Manufacture Of Parenter...
Certificate Number : CEP 2005-019 - Rev 04
Status : Valid
Issue Date : 2025-11-17
Type : Chemical
Substance Number : 559

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Certificate Number : R1-CEP 2000-040 - Rev 02
Status : Valid
Issue Date : 2019-09-12
Type : Chemical
Substance Number : 559

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Certificate Number : R1-CEP 2000-039 - Rev 01
Status : Valid
Issue Date : 2019-09-12
Type : Chemical
Substance Number : 559

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] FINISHED DOSAGE FORMULATIONS
EXCIPIENTS BY APPLICATIONS
Application : Disintegrants & Superdisintegrants
Excipient Details : Mannogem 2080 exhibits excellent flow, disintegration and compression properties.
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Category : Disintegrants & Superdisintegrants
Application : Disintegrants & Superdisintegrants
Excipient Details : F-Melt Type M is used in various dosage forms like orally disintegrating tablets (ODTs), sachets, dispersible tablets, chewable tablets and sublingual formulations.
Pharmacopoeia Ref : Conforms to Japanese Pharmaceu...
Technical Specs : Not Available
Ingredient(s) : Mannitol
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Category : Disintegrants & Superdisintegrants
Application : Disintegrants & Superdisintegrants
Excipient Details : F-Melt Type C is a pharmaceutical excipient used in oral dosage forms like orally disintegrating tablets, sachets, dispersible tablets, chewable tablets and sublingual tablets.
Pharmacopoeia Ref : Conforms to Japanese Pharmaceu...
Technical Specs : Not Available
Ingredient(s) : Mannitol
MARKET PLACE
REF. STANDARDS & IMPURITIES