01 1Dr. Paul Lohmann GmbH KG
02 1Formosa Laboratories
03 1Global Calcium
04 1Guangzhou Tosun Pharmaceutical
05 1Macco Organiques Inc
06 2Niacet b.v
07 1Stason Pharmaceuticals, Inc.
08 1Sudeep Pharma
09 1Suven Life Sciences Limited
10 1Valaji PharmaChem
11 1Vasa Pharmachem
12 1West Bengal Chemicals Industries
01 1Canada
02 1China
03 1Germany
04 6India
05 1Taiwan
06 3U.S.A
01 7Active
02 6Blank
01 1Valid
02 12Blank
01 13Blank
01 1WC-0042
02 1WC-0104A5-A6
03 11Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2013-09-10
Pay. Date : 2013-08-29
DMF Number : 23735
Submission : 2010-04-21
Status : Active
Type : II
NDC Package Code : 66499-0037
Start Marketing Date : 2009-03-26
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-03-04
Pay. Date : 2019-12-19
DMF Number : 29166
Submission : 2015-03-11
Status : Active
Type : II
NDC Package Code : 55897-002
Start Marketing Date : 2012-02-17
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-08
Pay. Date : 2012-12-13
DMF Number : 18997
Submission : 2005-11-25
Status : Active
Type : II
NDC Package Code : 53674-000
Start Marketing Date : 2013-12-04
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 : 19520
Submission : 2006-05-24
Status : Active
Type : IV
NDC Package Code : 53674-000
Start Marketing Date : 2013-12-04
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-10-20
Pay. Date : 2021-09-24
DMF Number : 35634
Submission : 2021-08-13
Status : Active
Type : II
Date of Issue : 2022-06-07
Valid Till : 2022-07-07
Written Confirmation Number : WC-0104A5-A6
Address of the Firm :
NDC Package Code : 64162-0158
Start Marketing Date : 2021-06-01
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 : 22550
Submission : 2009-02-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22752
Submission : 2009-04-30
Status : Active
Type : II
Date of Issue : 2019-07-15
Valid Till : 2022-07-14
Written Confirmation Number : WC-0042
Address of the Firm :
Certificate Number : R1-CEP 2011-033 - Rev 02
Issue Date : 2021-06-14
Type : Chemical
Substance Number : 2128
Status : Valid
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