01 1Amster Microcell
02 1Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
03 1Huzhou Zhanwang Pharmaceutical Co.,Ltd.
04 1MLA Group
05 1MLA Group of Industries
06 1Mallinckrodt Pharmaceuticals
07 1Neelkanth Finechem
08 2Nitika Pharmaceutical Specialities
09 1Prachin Chemical
10 1Roquette
11 1Shandong Liaocheng E Hua Pharmaceutical
12 1Sudeep Pharma
13 1Valtris
14 2Blank
01 15Active
02 1Inactive
01 16Blank
01 16Blank
01 16Blank
GDUFA
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DMF Number : 34101
Submission : 2020-05-06
Status : Active
Type : IV
GDUFA
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DMF Number : 38148
Submission : 2023-06-01
Status : Active
Type : IV
GDUFA
DMF Review : N/A
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DMF Number : 33148
Submission : 2018-10-11
Status : Active
Type : IV
GDUFA
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DMF Number : 38164
Submission : 2023-05-12
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 36212
Submission : 2021-09-10
Status : Active
Type : IV
GDUFA
DMF Review : N/A
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DMF Number : 32690
Submission : 2018-04-06
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33414
Submission : 2019-05-08
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 29612
Submission : 2015-06-25
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 38953
Submission : 2023-09-27
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18912
Submission : 2005-10-24
Status : Inactive
Type : IV
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