 Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
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 : 24122
Submission : 2010-08-30
Status : Active
Type : IV
 
											 
												GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35711
Submission : 2021-11-03
Status : Active
Type : IV

 
											 
												GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31236
Submission : 2016-12-06
Status : Active
Type : IV

 
											 
												GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34401
Submission : 2019-12-11
Status : Active
Type : IV

 
											 
												GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17414
Submission : 2004-05-27
Status : Inactive
Type : IV

 FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
 Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
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 : 24122
Submission : 2010-08-30
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34401
Submission : 2019-12-11
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17414
Submission : 2004-05-27
Status : Inactive
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31236
Submission : 2016-12-06
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35711
Submission : 2021-11-03
Status : Active
Type : IV

 FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FINISHED DOSAGE FORMULATIONS
 
										 
										Drug : IMJUDO
Dosage Form : INJECTABLE; INTRAVENOUS
Application Number : 761289
Country : US
Patented : No

 
										 
										Drug : VANCOMYCIN HYDROCHLORIDE
Dosage Form : POWDER; INTRAVENOUS, ORAL
Application Number : 210274
Country : US
Patented : No

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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EXCIPIENTS BY APPLICATIONS
 
												 
												 
												 
												Application : Parenteral
Excipient Details : Trehalose acts as a stabilizer for liposomes during the drying process and is also utilized in parenteral formulations.

 
												REF. STANDARDS & IMPURITIES
