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01 1Jai Radhe Sales
02 13F Industries
03 1Envee Drugs
04 1Faci Asia Pacific
05 1IQT Industrias Quimicas Taubate
06 1Keval Exports
07 1Mallinckrodt Pharmaceuticals
08 1Nitika Pharmaceutical Specialities
09 1PMC Biogenix
10 1Peter Greven Nederland C.V
11 1SO.G.I.S Industria Chimica SpA IT 26048 Sospiro
12 1Skotmark Speciality Chemicals
13 1Sudeep Pharma
14 1Sunshine Organics
15 1Valaji PharmaChem
16 1Vasa Pharmachem
01 1Brazil
02 11India
03 1Ireland
04 1Italy
05 1Netherlands
06 1U.S.A
01 7Active
02 9Blank
01 3Valid
02 13Blank
01 16Blank
01 16Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35085
Submission : 2020-08-11
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16126
Submission : 2002-09-06
Status : Active
Type : IV
Certificate Number : CEP 2021-296 - Rev 00
Issue Date : 2024-06-10
Type : Chemical
Substance Number : 229
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21490
Submission : 2008-03-26
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36237
Submission : 2021-11-16
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36001
Submission : 2021-06-08
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20585
Submission : 2007-06-07
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29879
Submission : 2015-09-25
Status : Active
Type : IV
Certificate Number : R1-CEP 2001-039 - Rev 00
Issue Date : 2006-11-02
Type : Chemical and TSE
Substance Number : 229
Status : Valid
Certificate Number : R1-CEP 2001-005 - Rev 01
Issue Date : 2008-05-16
Type : TSE
Substance Number : 229
Status : Valid
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