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DMF Number : 16037
Submission : 2002-07-03
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
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DMF Number : 17044
Submission : 2003-12-22
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DMF Number : 24099
Submission : 2010-08-27
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DMF Number : 28402
Submission : 2014-06-18
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DMF Number : 39035
Submission : 2023-10-27
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Type : II
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DMF Number : 41483
Submission : 2025-03-21
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DMF Number : 39456
Submission : 2024-02-06
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DMF Number : 19954
Submission : 2006-10-30
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DMF Number : 20960
Submission : 2007-10-11
Status : Active
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GDUFA
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Pay. Date :
DMF Number : 24099
Submission : 2010-08-27
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 : 16037
Submission : 2002-07-03
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28402
Submission : 2014-06-18
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 :
Pay. Date :
DMF Number : 32464
Submission : 2018-02-15
Status : Active
Type : IV
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 : 19954
Submission : 2006-10-30
Status : Active
Type : IV
GDUFA
DMF Review : N/A
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DMF Number : 14891
Submission : 2000-05-16
Status : Active
Type : IV
GDUFA
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DMF Number : 18143
Submission : 2005-03-08
Status : Active
Type : IV
FINISHED DOSAGE FORMULATIONS
EXCIPIENTS BY APPLICATIONS
Application : Taste Masking
Excipient Details : Mannitol is used as a filler, bulking agent and taste masking agent in ODT formulations such as tablets.
Application : Taste Masking
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
Application : Parenteral
Excipient Details : It is used in producing the injection solution, reducing the encephalic pressure, the intraocular pressure etc.
Pharmacopoeia Ref : CP/BP/ EP/ USP/IP
Technical Specs : Pharma Grade/ Medicine Grade/Injectable Grade
Ingredient(s) : Mannitol
Brand Name : Microlex® ML-Inj 500
Application : Parenteral
Excipient Details : It is used as Diurectic-osmotic for injectable solution, Dialysis solution, Injectible and Parenteral solution.
Pharmacopoeia Ref : Monograph- Ph.Eur, USP/NF, JP/...
Technical Specs : Not Available
Ingredient(s) : Mannitol
Brand Name : PEARLITOL® BIOPHARMA
Application : Parenteral
Excipient Details : Its range offers a unique blend of exceptional physical and chemical stability and no hygroscopicity.
Pharmacopoeia Ref : USP/EP/JP
Technical Specs : Not Available
Ingredient(s) : Mannitol, low endotoxin
Application : Parenteral
Excipient Details : Its range offers a unique blend of exceptional physical and chemical stability and no hygroscopicity.
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