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01 1FERMION OY Espoo FI
02 1ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN
03 1F.I.S. - FABBRICA ITALIANA SINTETICI S.P.A. Montecchio Maggiore IT
04 1F.I.S. - Fabbrica Italiana Sintetici S.p.A. Montecchio Maggiore IT
05 1JINAN JINDA PHARMACEUTICAL CHEMISTRY CO., LTD. Zhangqiu CN
06 1MACLEODS PHARMACEUTICALS LIMITED Mumbai IN
07 2MAITHRI DRUGS PRIVATE LIMITED Bonthapally Village IN
08 2MANGALAM DRUGS & ORGANICS LTD. Mumbai IN
09 2MANKIND PHARMA LIMITED New Delhi IN
10 1MYLAN LABORATORIES LIMITED Hyderabad IN
11 1OMSAV PHARMA RESEARCH PRIVATE LIMITED Mumbai IN
12 2UNIMARK REMEDIES LIMITED Mumbai IN
01 6Nitrofurantoin
02 1Nitrofurantoin, Anhydrate form-β
03 1Nitrofurantoin, Macrocrystal
04 7Nitrofurantoin, Macrocrystals
05 1Nitrofurantoin, Macrocrystals (Process-II)
01 1China
02 1Finland
03 2Gabon
04 9India
05 2Italy
06 1U.S.A
01 2Suspended by Holder
02 12Valid
03 1Withdrawn by EDQM Failure to CEP procedure
04 1Withdrawn by Holder
Certificate Number : R0-CEP 2019-206 - Rev 02
Status : Valid
Issue Date : 2023-03-16
Type : Chemical
Substance Number : 101
Nitrofurantoin, Anhydrate form-β
Certificate Number : CEP 2023-364 - Rev 00
Status : Valid
Issue Date : 2024-08-12
Type : Chemical
Substance Number : 101
Certificate Number : R0-CEP 2019-181 - Rev 00
Status : Valid
Issue Date : 2021-09-29
Type : Chemical
Substance Number : 101
Certificate Number : R1-CEP 2016-212 - Rev 00
Status : Valid
Issue Date : 2023-06-14
Type : Chemical
Substance Number : 101
Certificate Number : R0-CEP 2022-074 - Rev 00
Status : Valid
Issue Date : 2022-12-12
Type : Chemical
Substance Number : 101
Certificate Number : CEP 2019-262 - Rev 01
Status : Valid
Issue Date : 2024-05-02
Type : Chemical
Substance Number : 101
Certificate Number : R0-CEP 2020-202 - Rev 00
Status : Valid
Issue Date : 2022-10-06
Type : Chemical
Substance Number : 101
Certificate Number : R0-CEP 2020-236 - Rev 00
Status : Valid
Issue Date : 2022-10-10
Type : Chemical
Substance Number : 101
Nitrofurantoin, Macrocrystals (Process-II)
Certificate Number : R0-CEP 2021-371 - Rev 00
Status : Valid
Issue Date : 2021-12-10
Type : Chemical
Substance Number : 101
Certificate Number : R0-CEP 2022-051 - Rev 00
Status : Valid
Issue Date : 2023-07-11
Type : Chemical
Substance Number : 101
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