Molecules / Nitrofurantoin

Nitrofurantoin API manufacturers

CAS 67-20-9 ATC J01XE01 Updated 9 July 2026
11
manufacturers with an active filing 10 of them hold a US DMF or a CEP
$216.72
median export price per kg $77.92 to $327.36 · 31 exporters · 2025
48
shortage records on file across 5 countries
297
finished-dose makers across 44 regulators
Showing 11 of 11 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Macleods Pharmaceuticals

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs and 2 valid CEPs for nitrofurantoin, filing since 2016. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.

US DMF
2 active
CEP
2 valid
Last FDA inspection
2024 · VAI
GMP recognised in
29 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
05

ASolution Pharmaceutical

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for nitrofurantoin, filing since 2023. Its 2026 FDA inspection closed as NAI.

US DMF
2 active
CEP
None on file
Last FDA inspection
2026 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
06
Credentials confirmed against the regulator files on 25 July 2026

Holds 3 active US DMFs for nitrofurantoin, filing since 1965. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
3 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Fermion Oy

Finland
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for nitrofurantoin, filing since 2019. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Unimark Remedies

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 4 active US DMFs for nitrofurantoin, filing since 2010. Its GMP is recognised in 5 markets.

US DMF
4 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
5 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
09
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for nitrofurantoin, filing since 2011. Its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
10

Omsav Pharma

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for nitrofurantoin, filing since 2021.

US DMF
2 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
11

Shree Jee Laboratory

India
Makes the API

Registered with SFDA (Saudi Arabia) for nitrofurantoin.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile

8 more manufacturers hold filings for nitrofurantoin

The names are listed below. The filings, inspection history and GMP certificates behind each one are available with a free account.

Maithri DrugsASolution PharmaceuticalF.I.S. – Fabbrica Italiana SinteticiFermion OyUnimark RemediesJinan Jinda Pharmaceutical ChemistryOmsav PharmaShree Jee Laboratory
Open the full list with a free account

Contract manufacturers (3)

Fermion Oy Finland F.I.S. – Fabbrica Italiana Sintetici Italy Tooba Pharmaceuticals India

Contract manufacturers make to order rather than holding their own filing for this molecule.

Finished-dose makers (33)

Amneal United States Amneal Pharmaceuticals of New York United States Biocon India Lupin India Micro Labs India PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma United States Pharmascience Canada Boehringer Ingelheim Pharma Gmbh Germany Dr. Reddy's Laboratories India Glenmark Pharmaceuticals s.r.o Czech Republic Procter & Gamble United States Teva Israel ANI Pharmaceuticals United States Lee Pharma India Bristol-Myers Squibb United States Inventia Healthcare India Jamp Pharma Canada Laboratorios Antillanos Edmar, S. A. (LAANED) Dominican Republic Pfizer Brasil Ltda Brazil Sandoz Switzerland

How this list is built

The order is set by active filings weighted by regulator, inspection outcomes and their recency, breadth of GMP recognition, and evidence of real exports, less any open risk flags. Every factor appears on the card it produced. Read the full method.

Active US DMFs
FDA, List of Drug Master Files
Valid CEPs
EDQM certificate database
Inspection outcomes
FDA inspection classifications
GMP certificates
EudraGMDP and national regulators
Price band
Customs export unit values for 2025. These are export values rather than contract prices for regulated-market grade material, which are higher.

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Also on this molecule

Price history 4 yrs Shortages 48 Recalls 5 Finished dose 33 Contract mfrs 3

By country

India 13

Export price by year

Year Median Exporters
2025 $216.72 31
2024 $285.00 18
2023 $236.50 22
2022 $269.74 11

US dollars per kilogram, customs export unit values.