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01 1Gangwal Healthcare
02 1Cyclo Therapeutics
03 1Roquette
04 1Shandong Binzhou Zhiyuan Biotechnology Co.Ltd
01 1China
02 1France
03 1India
04 1U.S.A
01 2Active
02 2Blank
01 2Valid
02 2Blank
01 4Blank
01 1WC-0432
02 3Blank
Date of Issue : 2022-07-08
Valid Till : 2024-11-04
Written Confirmation Number : WC-0432
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28889
Submission : 2014-12-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30897
Submission : 2016-08-29
Status : Active
Type : II
Certificate Number : R1-CEP 2015-264 - Rev 00
Issue Date : 2022-04-04
Type : Chemical
Substance Number : 1804
Status : Valid
Certificate Number : CEP 2022-219 - Rev 00
Issue Date : 2023-11-27
Type : Chemical
Substance Number : 1804
Status : Valid
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