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02 1ALP Pharm
03 1Aurobindo Pharma Limited
04 1Charioteer
05 1Chemeca Drugs
06 1Fleming Laboratories
07 1Harman Finochem
08 1Laboratorio Chimico Internazionale Spa
09 1Maiden Group
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11 1Polydrug Laboratories Private Limited
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13 1Siegfried AG
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01 1WC-0044
02 1WC-0127
03 1WC-0220
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GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-31
Pay. Date : 2013-01-03
DMF Number : 21064
Submission : 2007-11-27
Status : Active
Type : II
Date of Issue : 2022-06-06
Valid Till : 2025-07-21
Written Confirmation Number : WC-0044
Address of the Firm : A-100, A-100/1, 2 & D-1, MIDC Ind. Area, Shendra, Aurangabad-431 210
NDC Package Code : 66064-5001
Start Marketing Date : 2008-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17444
Submission : 2004-06-03
Status : Active
Type : II
Certificate Number : R0-CEP 2004-128 - Rev 00
Issue Date : 2008-05-14
Type : Chemical
Substance Number : 1689
Status : Expired
NDC Package Code : 52286-0021
Start Marketing Date : 2012-10-26
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-12-05
Pay. Date : 2013-03-15
DMF Number : 23100
Submission : 2009-09-09
Status : Active
Type : II
Date of Issue : 2022-09-30
Valid Till : 2025-08-04
Written Confirmation Number : WC-0127
Address of the Firm : A1/B, SIPCOT Industrial Complex, Kudikadu, Cuddalore-607 005
NDC Package Code : 72643-017
Start Marketing Date : 1982-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-11-05
Pay. Date : 2020-09-17
DMF Number : 35149
Submission : 2020-09-28
Status : Active
Type : II
NDC Package Code : 77777-112
Start Marketing Date : 2019-09-10
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5240
Submission : 1984-02-09
Status : Active
Type : II
NDC Package Code : 17381-080
Start Marketing Date : 2010-04-08
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-09-21
Pay. Date : 2013-09-13
DMF Number : 4416
Submission : 1982-01-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24546
Submission : 2011-01-12
Status : Inactive
Type : II
NDC Package Code : 52286-0021
Start Marketing Date : 2012-10-26
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25687
Submission : 2012-01-02
Status : Inactive
Type : II
Date of Issue : 2017-11-30
Valid Till : 2020-11-29
Written Confirmation Number : WC-0220
Address of the Firm : N-37 Additional MIDC Ambernath Anand Nagar Ambernath E -421506 Maharshtra State
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19161
Submission : 2006-02-08
Status : Inactive
Type : II
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