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01 1Gangwal Healthcare
02 1Alcedo Pharmachem
03 1Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
04 1CordenPharma
05 1FMCCorporation - ICG
06 1Fujian Freemind Pharm
07 1JRS Pharma
08 1Jiangxi Alpha Hi-tech Pharmaceutical
09 1Maruti Chemicals
10 1Nitika Pharmaceutical Specialities
11 1Prachin Chemical
12 2Rank Organics
13 1Srikem Laboratories Pvt. Ltd
14 1Standard Chem. & Pharm. Co., Ltd
15 1Syn-Tech Chem. & Pharm
16 1Unipex
17 1Blank
01 13Active
02 1Inactive
03 4Blank
01 3Valid
02 15Blank
01 18Blank
01 18Blank
GDUFA
DMF Review : N/A
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DMF Number : 37309
Submission : 2022-07-12
Status : Active
Type : IV
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DMF Number : 33435
Submission : 2018-12-24
Status : Active
Type : IV
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DMF Number : 39364
Submission : 2024-01-12
Status : Active
Type : IV
GDUFA
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DMF Number : 36480
Submission : 2021-12-29
Status : Active
Type : IV
GDUFA
DMF Review : N/A
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DMF Number : 36276
Submission : 2021-10-04
Status : Active
Type : IV
GDUFA
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DMF Number : 26686
Submission : 2012-04-08
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38822
Submission : 2023-11-27
Status : Active
Type : IV
GDUFA
DMF Review : N/A
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DMF Number : 32792
Submission : 2018-04-16
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 36998
Submission : 2023-03-28
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 20643
Submission : 2007-06-15
Status : Inactive
Type : IV
Certificate Number : CEP 2023-052 - Rev 00
Issue Date : 2024-06-12
Type : Chemical
Substance Number : 1567
Status : Valid
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