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Mitomycin Generic API Manufacturers
Several generic applications have been filed for Mitomycin. The first generic version for Mitomycin was by Bristol Myers Co and was approved on Approved Prior to Jan 1, 1982. And the latest generic version is by Fresenius Kabi Usa Llc and was approved on Apr 5, 2024.
Given below is the list of companies who have filed for
Mitomycin generic, along with the locations of their manufacturing plants worldwide.
1. ACCORD HLTHCARE
Accord Healthcare Inc has filed for 3 different strengths of generic version for Mitomycin. 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
5MG/VIAL
(reference standard)
injectable
Prescription
INJECTION
AP
Apr 30, 1998
20MG/VIAL
injectable
Discontinued
INJECTION
N/A
Apr 30, 1998
40MG/VIAL
(reference standard)
injectable
Prescription
INJECTION
AP
Aug 11, 2009
2. BRISTOL MYERS
Bristol Myers Co has filed for 3 different strengths of generic version for Mitomycin. All of these versions come by the name MUTAMYCIN. Given below are the
details of the strengths of this generic introduced by
Bristol Myers.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
20MG/VIAL
injectable
Discontinued
INJECTION
N/A
Approved Prior to Jan 1, 1982
5MG/VIAL
injectable
Discontinued
INJECTION
N/A
Approved Prior to Jan 1, 1982
40MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
injectable
Discontinued
INJECTION
N/A
Mar 10, 1988
Manufacturing Plant Locations
New
Bristol Myers'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 Bristol Myers as present at those locations.
Country
City
Firm Name
United States
Mayaguez
Bristol Myers Squibb Caribbean Company
Catano
Bristol Myers Squibb Pr
Princeton
Bristol Myers Squibb
Plainsboro
Bristol Myers Squibb Company
3. EUGIA PHARMA
Eugia Pharma Specialities Ltd has filed for 3 different strengths of generic version for Mitomycin. Given below are the
details of the strengths of this generic introduced by
Eugia Pharma.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
40MG/VIAL
injectable
Prescription
INJECTION
AP
Oct 30, 2023
5MG/VIAL
injectable
Prescription
INJECTION
AP
Oct 30, 2023
20MG/VIAL
injectable
Prescription
INJECTION
AP
Oct 30, 2023
Manufacturing Plant Locations
New
Eugia Pharma'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 Eugia Pharma as present at those locations.
Country
City
Firm Name
India
Riico Industrial Area
EUGIA Pharma Specialities Limited
Pashamylaram
Eugia Pharma Specialities Limited
Medchal-Malkajgiri District
EUGIA Pharma Specialities Limited
4. FRESENIUS KABI USA
Fresenius Kabi Usa Llc has filed for 3 different strengths of generic version for Mitomycin. 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
5MG/VIAL
injectable
Prescription
INJECTION
AP
Apr 5, 2024
40MG/VIAL
injectable
Prescription
INJECTION
AP
Apr 5, 2024
20MG/VIAL
injectable
Prescription
INJECTION
AP
Apr 5, 2024
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
Lake Zurich
Fresenius Kabi USA, LLC
Skokie
Fresenius Kabi USA LLC
Wilson
Fresenius Kabi USA, LLC
Bensenville
Fresenius Kabi USA LLC (FK USA)
Melrose Park
Fresenius Kabi USA LLC
Melrose Park
Fresenius Kabi USA, LLC
Grand Island
Fresenius Kabi USA, LLC
North Andover
Fresenius Kabi USA, LLC
5. GLAND
Gland Pharma Ltd has filed for 3 different strengths of generic version for Mitomycin. Given below are the
details of the strengths of this generic introduced by
Gland.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
20MG/VIAL
injectable
Prescription
INJECTION
AP
Oct 20, 2021
5MG/VIAL
injectable
Prescription
INJECTION
AP
Oct 20, 2021
40MG/VIAL
injectable
Prescription
INJECTION
AP
Nov 22, 2022
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
Malur
Gland Chemicals Pvt Ltd.
Sriperumbudur
Gland Chemical Private Limited
Aurangabad
Gland Chemical Private Limited
Hyderabad
Gland Pharma Limited
Parawada, Visakhapatnam
Gland Pharma Limited
6. HIKMA
Hikma Pharmaceuticals Usa Inc has filed for 3 different strengths of generic version for Mitomycin. Given below are the
details of the strengths of this generic introduced by
Hikma.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
5MG/VIAL
injectable
Prescription
INJECTION
AP
Dec 23, 1999
20MG/VIAL
injectable
Prescription
INJECTION
AP
Dec 23, 1999
40MG/VIAL
injectable
Prescription
INJECTION
AP
Jun 2, 1999
Manufacturing Plant Locations
New
Hikma's manufacturing plants are situated in 3 countries - United States, Portugal, Jordan. Given below are the details of these plant locations as well as the firm names of Hikma as present at those locations.
Country
City
Firm Name
United States
Eatontown
Hikma Pharmaceuticals USA, Inc.
Cherry Hill
Hikma Pharmaceuticals USA Inc.
Carlsbad
Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Dayton
Hikma Injectables USA Inc
Portugal
Terrugem Snt
Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman
Hikma Pharmaceuticals LLC
7. HOSPIRA
Hospira Inc has filed for 1 generic for Mitomycin. Given below are the
details of the strengths of this generic introduced by
Hospira.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
20MG/VIAL
injectable
Discontinued
INJECTION
N/A
Nov 29, 1995
Manufacturing Plant Locations
New
Hospira's manufacturing plants are situated in 3 countries - Australia, United States, Dominican Republic (the). Given below are the details of these plant locations as well as the firm names of Hospira as present at those locations.
Country
City
Firm Name
Australia
Mulgrave
Hospira Australia Pty Ltd.
United States
Morgan Hill
Hospira Inc
Clayton
Hospira, Inc.
Mcpherson
Hospira, Inc., A Pfizer Company
Pleasant Prairie
Hospira Worldwide, LLC d.b.a. Hospira, a Pfizer-owned Company
Lake Forest
Hospira Inc
Rocky Mount
Hospira, Inc.
Dominican Republic (the)
Haina, San Cristobal
Hospira, Ltd.
8. MEITHEAL
Meitheal Pharmaceuticals Inc has filed for 3 different strengths of generic version for Mitomycin. Given below are the
details of the strengths of this generic introduced by
Meitheal.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
40MG/VIAL
injectable
Prescription
INJECTION
AP
Sep 6, 2022
5MG/VIAL
injectable
Prescription
INJECTION
AP
Sep 8, 2022
20MG/VIAL
(reference standard)
injectable
Prescription
INJECTION
AP
Sep 8, 2022
9. RK PHARMA
Rk Pharma Inc has filed for 3 different strengths of generic version for Mitomycin. Given below are the
details of the strengths of this generic introduced by
Rk Pharma.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
5MG/VIAL
injectable
Prescription
INJECTION
AP
Oct 13, 2017
20MG/VIAL
injectable
Prescription
INJECTION
AP
Oct 13, 2017
40MG/VIAL
injectable
Prescription
INJECTION
AP
Oct 13, 2017
Manufacturing Plant Locations
New
Rk Pharma'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 Rk Pharma as present at those locations.
