01 1ACS DOBFAR SPA
02 1Auronext Pharma Private Limited
03 1Choongwae Pharma Corporation
04 1Hospira, Inc.
05 1Jeil Pharmaceutical Co., Ltd
06 1Kaliberr Labs
07 1RANBAXY LABORATORIES LIMITED
08 1Sandoz B2B
09 1Sun Pharmaceutical Industries Limited
10 1Tecoland Corporation
11 1Unimark Remedies Limited
12 1Unipex
13 1Zhuhai United Laboratories Co ., Ltd.
01 1China
02 1France
03 5India
04 1Italy
05 1South Korea
06 1Switzerland
07 2U.S.A
08 1Blank
01 2Active
02 4Inactive
03 7Blank
01 1Valid
02 1Withdrawn by Holder
03 11Blank
01 1219MF10001
02 1304MF10136
03 11Blank
01 1WC-0216
02 12Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2013-11-20
Pay. Date : 2013-11-04
DMF Number : 21594
Submission : 2008-05-05
Status : Active
Type : II
Registration Number : 304MF10136
Registrant's Address : Viale Addetta, 4/12, 20067 Tribiano (Milan) Italy
Initial Date of Registration : 2022-10-05
Latest Date of Registration : --
NDC Package Code : 52946-0928
Start Marketing Date : 2022-10-07
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Sungjin Exim Co., Ltd.
Registration Date : 2021-07-19
Registration Number : 20201015-210-J-652(1)
Manufacturer Name : ACS Dobfar SpA@[Cilastatin Manufacturing Plant]ACS Dobfar SPA
Manufacturer Address : Viale Addetta, 2a/12-3/5 20067 Tribiano, Milano, Italy@Via Tonale, 87-24061 Albano Sant' Alessandro Bergamo Italy
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-01-05
Pay. Date : 2014-07-10
DMF Number : 28365
Submission : 2014-06-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20089
Submission : 2006-12-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21698
Submission : 2008-07-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23307
Submission : 2009-11-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28929
Submission : 2015-01-02
Status : Inactive
Type : II
Certificate Number : R1-CEP 2009-179 - Rev 02
Issue Date : 2022-02-21
Type : Chemical
Substance Number : 1408
Status : Valid
Date of Issue : 2022-07-06
Valid Till : 2025-07-04
Written Confirmation Number : WC-0216
Address of the Firm :
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