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01 1Jai Radhe Sales
02 1Archimica
03 2Bo-Chem Pvt Ltd
04 3Bristol Myers Squibb
05 1CHEMSPEC CHEMICALS PVT LTD
06 1Fermenta Biotech Limited
07 1Guangzhou Tosun Pharmaceutical
08 1Nishchem International Pvt. Ltd
09 2Olon S.p.A
10 1Qilu Pharmaceutical
11 1Qilu Tianhe Pharmaceutical Co., Ltd.
12 1Sakar Healthcare
13 1Shandong Anxin Pharmaceutical
01 4China
02 7India
03 3Italy
04 3U.S.A
01 4Active
02 5Inactive
03 8Blank
01 4Valid
02 13Blank
01 1222MF10097
02 16Blank
01 17Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-02-13
Pay. Date : 2019-02-08
DMF Number : 12754
Submission : 1997-11-14
Status : Active
Type : II
Certificate Number : R1-CEP 2003-120 - Rev 03
Issue Date : 2020-09-18
Type : Chemical
Substance Number : 1616
Status : Valid
NDC Package Code : 55512-0003
Start Marketing Date : 2009-09-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-05-13
Pay. Date : 2012-12-13
DMF Number : 20615
Submission : 2007-06-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11899
Submission : 1996-03-25
Status : Active
Type : II
Certificate Number : CEP 2022-263 - Rev 00
Issue Date : 2024-01-17
Type : Chemical
Substance Number : 1616
Status : Valid
Registration Number : 222MF10097
Registrant's Address : Strada Rivoltana Km 6/7 20053 Rodano Milano Italy
Initial Date of Registration : 2010-03-17
Latest Date of Registration : --
NDC Package Code : 17337-0022
Start Marketing Date : 2012-12-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-07-26
Pay. Date : 2022-05-31
DMF Number : 37146
Submission : 2022-06-09
Status : Active
Type : II
Certificate Number : R1-CEP 2003-015 - Rev 05
Issue Date : 2023-04-03
Type : Chemical
Substance Number : 1616
Status : Valid
NDC Package Code : 17337-0022
Start Marketing Date : 2012-12-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16458
Submission : 2003-02-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2259
Submission : 1974-04-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2452
Submission : 1975-05-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8361
Submission : 1989-12-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2258
Submission : 1974-04-09
Status : Inactive
Type : II
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