01 1Emcure Pharmaceuticals
02 1Heraeus Holding
03 1Hikma Pharmaceuticals
04 1IDT Australia Limited
05 1Indena
06 1Jiangsu Hengrui Medicine
07 1MSN Laboratories
08 1Natco Pharma
09 1Olon S.p.A
10 1SEACROSS PHARMACEUTICALS
11 1Sakar Healthcare
12 1Sichuan Huiyu Pharmaceutical
13 1Teva API
14 1Viatris
15 3Blank
01 1Australia
02 2China
03 1Germany
04 4India
05 1Israel
06 2Italy
07 1U.S.A
08 2United Kingdom
09 3Blank
01 7Active
02 6Inactive
03 4Blank
01 17Blank
01 1229MF10141
02 16Blank
01 1WC-0157
02 1WC-0226
03 1WC-0349
04 1WC-0372
05 13Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38406
Submission : 2023-08-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14170
Submission : 1999-06-01
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-04-01
Pay. Date : 2014-10-15
DMF Number : 13911
Submission : 1998-12-24
Status : Active
Type : II
Registration Number : 229MF10141
Registrant's Address : Heraeusstr. 12-14; 63450 Hanau; Germany
Initial Date of Registration : 2017-07-25
Latest Date of Registration : --
Registrant Name : Dong-In Pharmaceutical Co., Ltd.
Registration Date : 2022-04-14
Registration Number : 20220414-210-J-1265
Manufacturer Name : Heraeus Deutschland GmbH & Co. K.G.
Manufacturer Address : Heraeusstraße 12-14 621, 787 63450 Hanau, Germany
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-03-08
Pay. Date : 2019-01-28
DMF Number : 31104
Submission : 2017-05-05
Status : Active
Type : II
Date of Issue : 2019-10-07
Valid Till : 2022-06-12
Written Confirmation Number : WC-0372
Address of the Firm :
NDC Package Code : 70225-1104
Start Marketing Date : 2017-12-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (0.1kg/.1kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-01-12
Pay. Date : 2017-10-10
DMF Number : 30424
Submission : 2016-03-31
Status : Active
Type : II
Date of Issue : 2022-09-02
Valid Till : 2025-05-05
Written Confirmation Number : WC-0349
Address of the Firm :
NDC Package Code : 54893-0045
Start Marketing Date : 2016-03-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Ace Pharma Co., Ltd.
Registration Date : 2023-02-17
Registration Number : 20230217-210-J-1447
Manufacturer Name : MSN Laboratories Private Limited
Manufacturer Address : Unit-II, Sy. No. 50, 53, 53/A, 54, 54/A.Kardanur (Village), Patancheru (Mandal), Sangareddy District, Telangana, Pincode: 502 300, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32746
Submission : 2018-06-12
Status : Active
Type : II
Date of Issue : 2019-10-07
Valid Till : 2022-07-02
Written Confirmation Number : WC-0226
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26383
Submission : 2012-09-05
Status : Inactive
Type : II
Date of Issue : 2019-10-11
Valid Till : 2022-07-02
Written Confirmation Number : WC-0157
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5396
Submission : 1984-06-12
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7518
Submission : 1988-06-10
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8228
Submission : 1989-09-26
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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