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 : 41447
Submission : 2025-03-06
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21014
Submission : 2007-11-02
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13102
Submission : 1998-07-29
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15916
Submission : 2002-03-29
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16285
Submission : 2002-12-02
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15909
Submission : 2001-12-21
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16284
Submission : 2002-12-02
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14644
Submission : 1999-12-23
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16066
Submission : 2002-07-10
Status : Inactive
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18730
Submission : 2005-09-06
Status : Active
Type : IV
FINISHED DOSAGE FORMULATIONS
ANHYDROUS LACTOSE
Route : BUCCAL
CAS : 63-42-3
UNII : 3SY5LH9PMK
Potency Amount : 23.75
Potency Unit : MG
Portfolio PDF
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Corporate PDF
ANHYDROUS LACTOSE
Route : IM - IV
CAS : 63-42-3
UNII : 3SY5LH9PMK
Potency Amount : 2.5
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
ANHYDROUS LACTOSE
Route : IM - IV
CAS : 63-42-3
UNII : 3SY5LH9PMK
Potency Amount : 2.5
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
ANHYDROUS LACTOSE
Route : INTRACAVITARY
CAS : 63-42-3
UNII : 3SY5LH9PMK
Potency Amount : 4.75
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
ANHYDROUS LACTOSE
Route : INTRAVENOUS
CAS : 63-42-3
UNII : 3SY5LH9PMK
Potency Amount : 28.75
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
ANHYDROUS LACTOSE
Route : IV(INFUSION)
CAS : 63-42-3
UNII : 3SY5LH9PMK
Potency Amount : 2.5
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
ANHYDROUS LACTOSE
Route : ORAL
CAS : 63-42-3
UNII : 3SY5LH9PMK
Potency Amount : 46.06
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
ANHYDROUS LACTOSE
Route : ORAL
CAS : 63-42-3
UNII : 3SY5LH9PMK
Potency Amount : 71.91
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
ANHYDROUS LACTOSE
Route : ORAL
CAS : 63-42-3
UNII : 3SY5LH9PMK
Potency Amount : 40
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
ANHYDROUS LACTOSE
Route : ORAL
CAS : 63-42-3
UNII : 3SY5LH9PMK
Potency Amount : 117
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
EXCIPIENTS BY APPLICATIONS
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17 May 2018
REF. STANDARDS & IMPURITIES