01 1Angene International
02 1Aurobindo Pharma Limited
03 1FandaChem
04 1Fresenius Kabi Anti-Infectives
05 1Fresenius SE & Co. KGaA
06 1J&H CHEM
01 2China
02 1Germany
03 1India
04 1Italy
05 1United Kingdom
01 1Active
02 5Blank
01 2Valid
02 4Blank
01 1220MF10224
02 5Blank
01 1WC-0121
02 5Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35278
Submission : 2021-10-15
Status : Active
Type : II
Certificate Number : CEP 2004-262 - Rev 07
Issue Date : 2024-06-12
Type : Chemical
Substance Number : 1359
Status : Valid
Certificate Number : CEP 2007-229 - Rev 05
Issue Date : 2023-11-30
Type : Chemical
Substance Number : 1359
Status : Valid
Registration Number : 220MF10224
Registrant's Address : Plot No. 2, Maitrivihar, Ameerprt, Hyderabad, Andhra Pradesh, India 500-038
Initial Date of Registration : 2008-11-10
Latest Date of Registration : --
Date of Issue : 2019-07-05
Valid Till : 2022-07-02
Written Confirmation Number : WC-0121
Address of the Firm :
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