01 2Dishman Carbogen Amcis
02 1Glochem Industries
03 1Guangzhou Topwork Chemical
04 1Hetero Drugs
05 1Jubilant Generics
06 2Lonza Group
07 1Unichem Laboratories Limited
08 1Viatris
09 1Zhejiang Huahai Pharmaceutical
01 2China
02 6India
03 2Switzerland
04 1U.S.A
01 6Active
02 4Inactive
03 1Blank
01 11Blank
01 11Blank
01 1WC-0040
02 1WC-0062
03 1WC-0135
04 1WC-0135A
05 7Blank
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GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 23274
Submission : 2009-11-17
Status : Active
Type : II
Date of Issue : 2022-07-04
Valid Till : 2025-07-03
Written Confirmation Number : WC-0040
Address of the Firm :
NDC Package Code : 65977-0046
Start Marketing Date : 1997-12-22
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
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DMF Number : 23834
Submission : 2010-06-03
Status : Active
Type : II
Date of Issue : 2022-06-17
Valid Till : 2025-07-21
Written Confirmation Number : WC-0062
Address of the Firm :
NDC Package Code : 53747-021
Start Marketing Date : 2010-06-03
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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DMF Number : 26230
Submission : 2012-06-22
Status : Active
Type : II
NDC Package Code : 64220-108
Start Marketing Date : 2011-02-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
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DMF Number : 18155
Submission : 2005-03-07
Status : Active
Type : II
Date of Issue : 2019-07-22
Valid Till : 2022-07-02
Written Confirmation Number : WC-0135
Address of the Firm :
Registrant Name : Handok Co., Ltd.
Registration Date : 2021-03-25
Registration Number : 20210325-209-J-911
Manufacturer Name : Dishman Carbogen Amcis Ltd.
Manufacturer Address : Survey No. 47 & 48, Paiki Sub Plot No. 1, Village: Lodariyal, Taluka: Sanand, Dist. Ahmedabad - 382 220, Gujarat, India
GDUFA
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DMF Number : 22863
Submission : 2009-08-31
Status : Active
Type : II
GDUFA
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DMF Number : 23790
Submission : 2010-04-30
Status : Active
Type : II
GDUFA
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DMF Number : 16790
Submission : 2003-08-22
Status : Inactive
Type : II
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DMF Number : 18079
Submission : 2005-02-09
Status : Inactive
Type : II
GDUFA
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DMF Number : 16703
Submission : 2003-07-14
Status : Inactive
Type : II
Date of Issue : 2019-12-03
Valid Till : 2022-07-21
Written Confirmation Number : WC-0135A
Address of the Firm :
Registrant Name : Handok Co., Ltd.
Registration Date : 2021-03-25
Registration Number : 20210325-209-J-911
Manufacturer Name : Dishman Carbogen Amcis Ltd.
Manufacturer Address : Survey No. 47 & 48, Paiki Sub Plot No. 1, Village: Lodariyal, Taluka: Sanand, Dist. Ahmedabad - 382 220, Gujarat, India
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 24009
Submission : 2010-07-29
Status : Inactive
Type : II
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