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List of Certificates of Suitability (CEPs) for Nitrofurantoin Active Pharmaceutical Ingredient (API) issued by the EDQM. Original Data: EDQM Database

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01 FERMION OY Espoo FI (1)

02 F.I.S. - FABBRICA ITALIANA SINTETICI S.P.A. Montecchio Maggiore IT (2)

03 JINAN JINDA PHARMACEUTICAL CHEMISTRY CO., LTD. Zhangqiu CN (1)

04 MACLEODS PHARMACEUTICALS LIMITED Mumbai IN (1)

05 MAITHRI DRUGS PRIVATE LIMITED Bonthapally Village IN (2)

06 MANGALAM DRUGS & ORGANICS LTD. Mumbai IN (2)

07 MANKIND PHARMA LIMITED New Delhi IN (2)

08 MYLAN LABORATORIES LIMITED Hyderabad IN (1)

09 OMSAV PHARMA RESEARCH PRIVATE LIMITED Mumbai IN (1)

10 UNIMARK REMEDIES LIMITED Mumbai IN (2)

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01 Nitrofurantoin (6)

02 Nitrofurantoin, Macrocrystal (1)

03 Nitrofurantoin, Macrocrystals (7)

04 Nitrofurantoin, Macrocrystals (Process-II) (1)

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01 China (1)

02 Finland (1)

03 Gabon (2)

04 India (8)

05 Italy (2)

06 U.S.A (1)

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01 Valid (13)

02 Withdrawn by EDQM Failure to CEP procedure (1)

03 Withdrawn by Holder (1)

URL Supplier Web Content
R1-CEP 2016-212 - Rev 00
Valid
Chemical
2023-06-14
101
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R0-CEP 2022-074 - Rev 00
Valid
Chemical
2022-12-12
101
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R0-CEP 2019-262 - Rev 00
Valid
Chemical
2021-09-09
101
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R0-CEP 2020-236 - Rev 00
Valid
Chemical
2022-10-10
101
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R0-CEP 2020-202 - Rev 00
Valid
Chemical
2022-10-06
101
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CEP 2019-092 - Rev 02
Valid
Chemical
2023-10-12
101
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R0-CEP 2021-371 - Rev 00
Valid
Chemical
2021-12-10
101
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R0-CEP 2022-051 - Rev 00
Valid
Chemical
2023-07-11
101
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R1-CEP 2011-108 - Rev 01
Valid
Chemical
2020-09-23
101
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Looking for 67-20-9 / Nitrofurantoin API manufacturers, exporters & distributors?

Nitrofurantoin manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Nitrofurantoin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Nitrofurantoin manufacturer or Nitrofurantoin supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Nitrofurantoin manufacturer or Nitrofurantoin supplier.

PharmaCompass also assists you with knowing the Nitrofurantoin API Price utilized in the formulation of products. Nitrofurantoin API Price is not always fixed or binding as the Nitrofurantoin Price is obtained through a variety of data sources. The Nitrofurantoin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Nitrofurantoin

Synonyms

67-20-9, Macrodantin, Furadantin, 5-nitrofurantoin, Furadonine, Furadantine

Cas Number

67-20-9

Unique Ingredient Identifier (UNII)

927AH8112L

About Nitrofurantoin

A urinary anti-infective agent effective against most gram-positive and gram-negative organisms. Although sulfonamides and antibiotics are usually the agents of choice for urinary tract infections, nitrofurantoin is widely used for prophylaxis and long-term suppression.

Nitrofurantoin Manufacturers

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.

Nitrofurantoin Suppliers

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.

Nitrofurantoin CEP

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.

Nitrofurantoin Manufacturers | Traders | Suppliers

Nitrofurantoin Manufacturers, Traders, Suppliers 1
Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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