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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 : CEP 2019-178 - Rev 01
Status : Valid
Issue Date : 2024-09-09
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 : CEP 2019-262 - Rev 01
Status : Valid
Issue Date : 2024-05-02
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
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 : CEP 2019-092 - Rev 02
Status : Valid
Issue Date : 2023-10-12
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
A Nitrofurantoin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nitrofurantoin, including repackagers and relabelers. The FDA regulates Nitrofurantoin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nitrofurantoin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Nitrofurantoin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nitrofurantoin supplier is an individual or a company that provides Nitrofurantoin active pharmaceutical ingredient (API) or Nitrofurantoin finished formulations upon request. The Nitrofurantoin suppliers may include Nitrofurantoin API manufacturers, exporters, distributors and traders.
click here to find a list of Nitrofurantoin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nitrofurantoin CEP of the European Pharmacopoeia monograph is often referred to as a Nitrofurantoin Certificate of Suitability (COS). The purpose of a Nitrofurantoin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Nitrofurantoin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Nitrofurantoin to their clients by showing that a Nitrofurantoin CEP has been issued for it. The manufacturer submits a Nitrofurantoin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Nitrofurantoin CEP holder for the record. Additionally, the data presented in the Nitrofurantoin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Nitrofurantoin DMF.
A Nitrofurantoin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Nitrofurantoin CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Nitrofurantoin suppliers with CEP (COS) on PharmaCompass.
We have 11 companies offering Nitrofurantoin
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