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 :
Pay. Date :
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 : 20960
Submission : 2007-10-11
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 : 41483
Submission : 2025-03-21
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39456
Submission : 2024-02-06
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
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 : 17044
Submission : 2003-12-22
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 :
Pay. Date :
DMF Number : 32464
Submission : 2018-02-15
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
Rev. Date :
Pay. Date :
DMF Number : 18143
Submission : 2005-03-08
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14891
Submission : 2000-05-16
Status : Active
Type : IV
Certificate Number : R1-CEP 2000-040 - Rev 02
Status : Valid
Issue Date : 2019-09-12
Type : Chemical
Substance Number : 559
Certificate Number : R1-CEP 2000-039 - Rev 01
Status : Valid
Issue Date : 2019-09-12
Type : Chemical
Substance Number : 559
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Mannitol, For Use In The Manufacture Of Parenter...
Certificate Number : CEP 2005-019 - Rev 03
Status : Valid
Issue Date : 2025-06-24
Type : Chemical
Substance Number : 559
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Omeprazole Sodium Sterile (Sterile dry powder of omeprazole sodium 35% in mannitol qs) IH
Date of Issue : 2022-08-12
Valid Till : 2025-07-06
Written Confirmation Number : WC-0378
Address of the Firm : Plot No. 100, 118G, Sec-56, Phase-IV, HSIIDC, Kundli, Sonipat, Haryana, INDIA Ku...
Pantoprazole Sodium Sterile (sterile dry powder of pantoprazole sodium 38 % in mannitol qs) IH
Date of Issue : 2022-08-12
Valid Till : 2025-07-06
Written Confirmation Number : WC-0378
Address of the Firm : Plot No. 100, 118G, Sec-56, Phase-IV, HSIIDC, Kundli, Sonipat, Haryana, INDIA Ku...
NDC Package Code : 57821-013
Start Marketing Date : 2022-12-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 49574-527
Start Marketing Date : 2019-04-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 50516-002
Start Marketing Date : 2014-05-07
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
FINISHED DOSAGE FORMULATIONS
MANNITOL
Route : ORAL
CAS :
UNII : 3OWL53L36A
Potency Amount : 32.58
Potency Unit : MG
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MANNITOL
Route : ORAL
CAS :
UNII : 3OWL53L36A
Potency Amount : 174.78
Potency Unit : MG
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MANNITOL
Route : ORAL
CAS :
UNII : 3OWL53L36A
Potency Amount : 174.76
Potency Unit : MG
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Product Web Link
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Corporate PDF
MANNITOL
Route : BUCCAL
CAS : 69-65-8
UNII : 3OWL53L36A
Potency Amount : 37.11
Potency Unit : MG
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MANNITOL
Route : BUCCAL
CAS : 69-65-8
UNII : 3OWL53L36A
Potency Amount : 97.69
Potency Unit : MG
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Virtual Booth
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MANNITOL
Route : BUCCAL/SUBLINGUAL
CAS : 69-65-8
UNII : 3OWL53L36A
Potency Amount : 52.5
Potency Unit : MG
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Product Web Link
Virtual Booth
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Corporate PDF
MANNITOL
Route : IM - IV
CAS : 69-65-8
UNII : 3OWL53L36A
Potency Amount : 2.5
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
MANNITOL
Route : IM - IV
CAS : 69-65-8
UNII : 3OWL53L36A
Potency Amount : 30
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
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Corporate PDF
MANNITOL
Route : IM - IV - SC
CAS : 69-65-8
UNII : 3OWL53L36A
Potency Amount : 0
Potency Unit : NA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
MANNITOL
Route : IM - SC
CAS : 69-65-8
UNII : 3OWL53L36A
Potency Amount : 0
Potency Unit : NA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
EXCIPIENTS BY APPLICATIONS
MARKET PLACE
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11 May 2024
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19 Aug 2023
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25 Aug 2018
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10 Jul 2025
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19 Jun 2025
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14 Jun 2025
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03 Feb 2025
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03 Dec 2024
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17 Oct 2024
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10 Jun 2024
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09 Dec 2023
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29 May 2023
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04 Nov 2022
REF. STANDARDS & IMPURITIES