01 1AbbVie Inc
02 1LGM Pharma
03 1Neuland Laboratories
04 1ALP Pharm
05 2Catalent Pharma Solutions
06 1Chongqing Huapont Pharmaceutical
07 1DISHMAN NETHERLANDS B.V.
08 1Dishman Carbogen Amcis
09 1DongWha Pharm
10 1Formosa Laboratories
11 1Hanways Chempharm
12 1Haoyuan Chemexpress Co.Ltd
13 1Nanjing Heron Pharmaceutical
14 1Sai Life Sciences Limited
15 1Sichuan Gowell Pharmaceutical
16 1Teva API
17 1Teva Pharmaceutical Industries
18 1Zhejiang Ausun Pharmaceutical
01 7China
02 3India
03 2Israel
04 1Netherlands
05 1South Korea
06 1Taiwan
07 4U.S.A
01 9Active
02 2Inactive
03 8Blank
01 19Blank
01 19Blank
01 1WC-0036
02 18Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24315
Submission : 2010-11-30
Status : Active
Type : II
NDC Package Code : 68513-1054
Start Marketing Date : 2011-09-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23895
Submission : 2010-06-18
Status : Active
Type : II
Date of Issue : 2022-07-28
Valid Till : 2025-06-16
Written Confirmation Number : WC-0036
Address of the Firm :
NDC Package Code : 58032-1001
Start Marketing Date : 2017-12-14
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 : 38269
Submission : 2023-08-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28550
Submission : 2014-07-30
Status : Active
Type : II
NDC Package Code : 48943-0033
Start Marketing Date : 2022-01-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25300
Submission : 2011-09-13
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-09-09
Pay. Date : 2012-11-21
DMF Number : 26545
Submission : 2012-11-14
Status : Active
Type : II
NDC Package Code : 14474-021
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 : Reviewed
Rev. Date : 2012-11-23
Pay. Date : 2012-11-13
DMF Number : 20865
Submission : 2007-09-19
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-11-08
Pay. Date : 2012-11-23
DMF Number : 21880
Submission : 2008-08-14
Status : Active
Type : II
NDC Package Code : 66499-0019
Start Marketing Date : 2008-01-16
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Kisan Pharmaceutical Co., Ltd.
Registration Date : 2018-04-27
Registration Number : 20151218-198-I-467-04(1)
Manufacturer Name : Formosa Laboratories, Inc. Louchu Plant
Manufacturer Address : 36, Hoping Street, Louchu, Taoyuan 33842, Taiwan
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16402
Submission : 2003-02-03
Status : Inactive
Type : II
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