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Fluorouracil Generic API Manufacturers
Several generic applications have been filed for Fluorouracil. The first generic version for Fluorouracil was by Spectrum Pharmaceuticals Inc and was approved on Oct 13, 1982. And the latest generic version is by Encube Ethicals Private Ltd and was approved on Feb 12, 2025.
Given below is the list of companies who have filed for
Fluorouracil generic, along with the locations of their manufacturing plants worldwide.
1. ABIC
Abic Ltd has filed for 1 generic for Fluorouracil. Given below are the
details of the strengths of this generic introduced by
Abic.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
50MG/ML
injectable
Discontinued
INJECTION
N/A
Mar 4, 1986
Manufacturing Plant Locations
New
Abic's manufacturing plants are situated in 2 countries - Canada, Israel. Given below are the details of these plant locations as well as the firm names of Abic as present at those locations.
Country
City
Firm Name
Canada
Montreal
Abich Inc
Israel
Netanya
Abic Ltd.
2. ABRAXIS PHARM
Abraxis Pharmaceutical Products has filed for 1 generic for Fluorouracil. Given below are the
details of the strengths of this generic introduced by
Abraxis Pharm.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
50MG/ML
injectable
Discontinued
INJECTION
N/A
Mar 12, 1987
3. ACCORD HLTHCARE
Accord Healthcare Inc has filed for 5 different strengths of generic version for Fluorouracil. Given below are the
details of the strengths of this generic introduced by
Accord Hlthcare.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
1GM/20ML (50MG/ML)
(reference standard)
injectable
Prescription
INJECTION
AP
Apr 26, 2007
5GM/100ML (50MG/ML)
(reference standard)
injectable
Prescription
INJECTION
AP
Apr 26, 2007
2.5GM/50ML (50MG/ML)
injectable
Discontinued
INJECTION
N/A
Apr 26, 2007
500MG/10ML (50MG/ML)
(reference standard)
injectable
Prescription
INJECTION
AP
Apr 26, 2007
5%
cream
Prescription
TOPICAL
AB
Oct 7, 2021
4. ALEMBIC
Alembic Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Fluorouracil. Given below are the
details of the strengths of this generic introduced by
Alembic.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
2.5GM/50ML (50MG/ML)
(reference standard)
injectable
Prescription
INJECTION
AP
Mar 3, 2023
5GM/100ML (50MG/ML)
injectable
Prescription
INJECTION
AP
Oct 18, 2023
Manufacturing Plant Locations
New
Alembic's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Alembic as present at those locations.
Bedford Laboratories Div Ben Venue Laboratories Inc has filed for 1 generic for Fluorouracil. Given below are the
details of the strengths of this generic introduced by
Bedford.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
50MG/ML
injectable
Discontinued
INJECTION
N/A
Jan 26, 1988
Manufacturing Plant Locations
New
Bedford's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Bedford as present at those locations.
Country
City
Firm Name
United States
Bedford
Bedford Research Foundation, Inc.
Shelbyville
Bedford Cheese Store Inc
Curryville
Bedford Farm Bureau Cooperative
6. DR REDDYS LABS SA
Dr Reddys Laboratories Sa has filed for 1 generic for Fluorouracil. Given below are the
details of the strengths of this generic introduced by
Dr Reddys Labs Sa.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
5%
cream
Prescription
TOPICAL
AB
Apr 11, 2008
7. EBEWE PHARMA
Ebewe Pharma Ges Mbh Nfg Kg has filed for 1 generic for Fluorouracil. Given below are the
details of the strengths of this generic introduced by
Ebewe Pharma.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
500MG/10ML (50MG/ML)
injectable
Discontinued
INJECTION
N/A
Aug 11, 2008
8. ENCUBE
Encube Ethicals Private Ltd has filed for 1 generic for Fluorouracil. Given below are the
details of the strengths of this generic introduced by
Encube.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
5%
cream
Prescription
TOPICAL
AB
Feb 12, 2025
Manufacturing Plant Locations
New
Encube's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Encube as present at those locations.
Country
City
Firm Name
India
Ponda
Encube Ethicals Pvt. Ltd.
Andheri East, Mumbai
Encube Ethicals Private Ltd
9. EUGIA PHARMA SPECLTS
Eugia Pharma Specialities Ltd has filed for 4 different strengths of generic version for Fluorouracil. Given below are the
details of the strengths of this generic introduced by
Eugia Pharma Speclts.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
500MG/10ML (50MG/ML)
injectable
Prescription
INJECTION
AP
Jul 17, 2012
1GM/20ML (50MG/ML)
injectable
Prescription
INJECTION
AP
Jul 17, 2012
2.5GM/50ML (50MG/ML)
injectable
Prescription
INJECTION
AP
Jul 17, 2012
5GM/100ML (50MG/ML)
injectable
Prescription
INJECTION
AP
Jul 17, 2012
10. EXTROVIS
Extrovis Ag has filed for 1 generic for Fluorouracil. Given below are the
details of the strengths of this generic introduced by
Extrovis.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
0.5%
cream
Discontinued
TOPICAL
N/A
Apr 20, 2015
11. FRESENIUS KABI USA
Fresenius Kabi Usa Llc has filed for 5 different strengths of generic version for Fluorouracil. Given below are the
details of the strengths of this generic introduced by
Fresenius Kabi Usa.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
2.5GM/50ML (50MG/ML)
injectable
Prescription
INJECTION
AP
Sep 30, 1998
500MG/10ML (50MG/ML)
injectable
Prescription
INJECTION
AP
Sep 30, 1998
1GM/20ML (50MG/ML)
injectable
Prescription
INJECTION
AP
Sep 30, 1998
5GM/100ML (50MG/ML)
injectable
Prescription
INJECTION
AP
Sep 30, 1998
50MG/ML
injectable
Discontinued
INJECTION
N/A
Nov 15, 2000
Manufacturing Plant Locations
New
Fresenius Kabi Usa's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Fresenius Kabi Usa as present at those locations.
Country
City
Firm Name
United States
North Andover
Fresenius Kabi USA, LLC
Bensenville
Fresenius Kabi USA LLC (FK USA)
Skokie
Fresenius Kabi USA LLC
Grand Island
Fresenius Kabi USA, LLC
Lake Zurich
Fresenius Kabi USA, LLC
Melrose Park
Fresenius Kabi USA, LLC
Wilson
Fresenius Kabi USA, LLC
Melrose Park
Fresenius Kabi USA LLC
12. GLAND
Gland Pharma Ltd has filed for 4 different strengths of generic version for Fluorouracil. Given below are the
details of the strengths of this generic introduced by
Gland.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
500MG/10ML (50MG/ML)
injectable
Prescription
INJECTION
AP
Oct 27, 2017
1GM/20ML (50MG/ML)
injectable
Prescription
INJECTION
AP
Oct 27, 2017
2.5GM/50ML (50MG/ML)
injectable
Prescription
INJECTION
AP
Dec 26, 2017
5GM/100ML (50MG/ML)
injectable
Prescription
INJECTION
AP
Dec 26, 2017
Manufacturing Plant Locations
New
Gland's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Gland as present at those locations.
Country
City
Firm Name
India
Visakhapatnam
Gland Pharma Limited
Hyderabad
Gland Pharma Limited, Units I+II Pashamylaram Site
Sriperumbudur
Gland Chemical Private Limited
Aurangabad
Gland Chemical Private Limited
Parawada, Visakhapatnam
Gland Pharma Limited
Malur
Gland Chemicals Pvt Ltd.
Hyderabad
Gland Pharma Limited
13. KINDOS
Kindos Pharmaceuticals Co Ltd has filed for 2 different strengths of generic version for Fluorouracil. Given below are the
details of the strengths of this generic introduced by
Kindos.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
2.5GM/50ML (50MG/ML)
injectable
Prescription
INJECTION
AP
Sep 24, 2024
5GM/100ML (50MG/ML)
injectable
Prescription
INJECTION
AP
Feb 6, 2025
Manufacturing Plant Locations
New
Kindos's manufacturing plants are situated in 1 country - China. Given below are the details of these plant locations as well as the firm names of Kindos as present at those locations.
Country
City
Firm Name
China
Chengdu
Kindos Pharmaceuticals Co., Ltd.
14. MARCHAR
Marchar Laboratories Inc Ltd has filed for 1 generic for Fluorouracil. Given below are the
details of the strengths of this generic introduced by
Marchar.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
50MG/ML
injectable
Discontinued
INJECTION
N/A
Jan 18, 1983
15. NOVAST LABS
Novast Laboratories Ltd has filed for 4 different strengths of generic version for Fluorouracil. Given below are the
details of the strengths of this generic introduced by
Novast Labs.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
5GM/100ML (50MG/ML)
injectable
Discontinued
INJECTION
N/A
Dec 11, 2019
2.5GM/50ML (50MG/ML)
injectable
Discontinued
INJECTION
N/A
Dec 11, 2019
500MG/10ML (50MG/ML)
injectable
Discontinued
INJECTION
N/A
Dec 12, 2019
1GM/20ML (50MG/ML)
injectable
Discontinued
INJECTION
N/A
Dec 12, 2019
16. PHARMACIA AND UPJOHN
Pharmacia And Upjohn Co has filed for 1 generic for Fluorouracil. This 50mg/ml version comes by the name ADRUCIL. Given below are the
details of the strengths of this generic introduced by
Pharmacia And Upjohn.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
50MG/ML
injectable
Discontinued
INJECTION
N/A
Jun 28, 1991
17. SAGENT PHARMS INC
Sagent Pharmaceuticals Inc has filed for 4 different strengths of generic version for Fluorouracil. Given below are the
details of the strengths of this generic introduced by
Sagent Pharms Inc.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
2.5GM/50ML (50MG/ML)
injectable
Prescription
INJECTION
AP
Feb 17, 2016
5GM/100ML (50MG/ML)
injectable
Prescription
INJECTION
AP
Feb 17, 2016
1GM/20ML (50MG/ML)
injectable
Prescription
INJECTION
AP
May 11, 2017
500MG/10ML (50MG/ML)
injectable
Prescription
INJECTION
AP
May 11, 2017
18. SANDOZ
Sandoz Inc has filed for 2 different strengths of generic version for Fluorouracil. Given below are the
details of the strengths of this generic introduced by
Sandoz.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
2.5GM/50ML (50MG/ML)
injectable
Discontinued
INJECTION
N/A
May 2, 2011
5GM/100ML (50MG/ML)
injectable
Discontinued
INJECTION
N/A
May 2, 2011
Manufacturing Plant Locations
New
Sandoz's manufacturing plants are situated in 4 countries - Austria, United States, Spain, India. Given below are the details of these plant locations as well as the firm names of Sandoz as present at those locations.
Country
City
Firm Name
Austria
Kundl
Sandoz GmbH
Langkampfen
Sandoz GmbH
United States
East Hanover
Sandoz Incorporated
Princeton
Sandoz Inc
Spain
Les Franqueses Del Valles
Sandoz Industrial Products S.A.
Palafolls
Sandoz Industrial Products, S.A.
India
Navi Mumbai
Sandoz Private Limited
19. SMITH AND NEPHEW
Smith And Nephew Solopak Div Smith And Nephew has filed for 1 generic for Fluorouracil. Given below are the
details of the strengths of this generic introduced by
Smith And Nephew.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
50MG/ML
injectable
Discontinued
INJECTION
N/A
Mar 26, 1987
Manufacturing Plant Locations
New
Smith And Nephew's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Smith And Nephew as present at those locations.
Country
City
Firm Name
United States
Goodlettsville
Smith and Nephew
20. SPECTRUM PHARMS
Spectrum Pharmaceuticals Inc has filed for 1 generic for Fluorouracil. Given below are the
details of the strengths of this generic introduced by
Spectrum Pharms.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
50MG/ML
injectable
Discontinued
INJECTION
N/A
Oct 13, 1982
21. TARO
Taro Pharmaceutical Industries Ltd has filed for 2 different strengths of generic version for Fluorouracil. Given below are the
details of the strengths of this generic introduced by
Taro.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
2%
solution
Prescription
TOPICAL
AT
Nov 5, 2003
5%
cream
Prescription
TOPICAL
AB
Mar 5, 2010
Manufacturing Plant Locations
New
Taro's manufacturing plants are situated in 3 countries - United States, Israel, Canada. Given below are the details of these plant locations as well as the firm names of Taro as present at those locations.
Country
City
Firm Name
United States
Honolulu
Taro Delight, LLC
Hawthorne
Taro Pharmaceuticals U.S.A., Inc.
Israel
Haifa
Taro Pharmaceutical Industries, Ltd.
Canada
Brampton
Taro Pharmaceuticals Inc.
22. TEVA PARENTERAL
Teva Parenteral Medicines Inc has filed for 1 generic for Fluorouracil. This 50mg/ml version comes by the name ADRUCIL. Given below are the
details of the strengths of this generic introduced by
Teva Parenteral.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
50MG/ML
injectable
Discontinued
INJECTION
N/A
Oct 18, 1991
Manufacturing Plant Locations
New
Teva Parenteral's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Teva Parenteral as present at those locations.
Country
City
Firm Name
United States
Irvine
Teva Parenteral Medicines, Inc.
23. TEVA PHARMS USA
Teva Pharmaceuticals Usa has filed for 3 different strengths of generic version for Fluorouracil. Given below are the
details of the strengths of this generic introduced by
Teva Pharms Usa.
