GDUFA
DMF Review : N/A
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DMF Number : 16037
Submission : 2002-07-03
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
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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
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DMF Number : 32464
Submission : 2018-02-15
Status : Active
Type : IV
GDUFA
DMF Review : N/A
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DMF Number : 17044
Submission : 2003-12-22
Status : Active
Type : IV
GDUFA
DMF Review : N/A
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DMF Number : 24099
Submission : 2010-08-27
Status : Active
Type : IV
GDUFA
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DMF Number : 28402
Submission : 2014-06-18
Status : Active
Type : IV
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DMF Number : 41483
Submission : 2025-03-21
Status : Active
Type : IV

GDUFA
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DMF Number : 39456
Submission : 2024-02-06
Status : Active
Type : IV

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DMF Number : 39035
Submission : 2023-10-27
Status : Active
Type : II

GDUFA
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DMF Number : 20960
Submission : 2007-10-11
Status : Active
Type : IV

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FINISHED DOSAGE FORMULATIONS
EXCIPIENTS BY APPLICATIONS
Application : Direct Compression
Excipient Details : Mannogem 2080 exhibits excellent flow, disintegration and compression properties.
Brand Name : Microlex® MLP 520
Application : Direct Compression
Excipient Details : Use in a wide range of oral applications such as wet or dry granulation, excipient of choice for flash release forms.
Pharmacopoeia Ref : Monograph- Ph.Eur, USP/NF
Technical Specs : Available in different particle size as 25.µ, 50.µ, 180.µ
Ingredient(s) : Mannitol
Application : Direct Compression
Excipient Details : Ludiflash is a ready-to-use orally disintegrating tablet (ODT) solution with superior mouthfeel.
Pharmacopoeia Ref : Ph. Eur., USP, JP: 90 % mannit...
Technical Specs : Not Available
Ingredient(s) : Mannitol
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REF. STANDARDS & IMPURITIES
Sigma-Aldrich empowers scientific discovery with top-quality solutions to accelerate research, innovation, and better health worldwide.
CAS Number : 69-65-8
Quantity Per Vial :
Sale Unit :
Price : $116.00
Details :
Monograph : PHR1007-1G
Storage : +2°C to +30°C
Code/Batch No :
CAS Number :
Quantity Per Vial :
Sale Unit :
Price : $116.00
Details :
Monograph : PHR1007-1G
Storage : +2?C to +30?C
Code/Batch No :

CAS Number : 69-65-8
Quantity Per Vial : 200
Sale Unit : mg
Price : $275.00
Details : Material Origin- Plant; USMCA- No; KORUS- No
Monograph :
Storage :
Code/Batch No : Catalog #1375105 / R039T0

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