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01 2Aspen Pharmacare Holdings

02 10medac

03 4Naprod Life Sciences

04 13Accord healthcare

05 3Accure Labs

06 3Aurobindo Pharma Limited

07 2Bristol Laboratories Ltd

08 4Bristol Myers Squibb

09 1Cherubino Limited

10 1EJ Busuttil Ltd

11 3Fresenius Kabi USA

12 3GLAND PHARMA LIMITED

13 1Glaukos

14 3Health Biotech

15 6Hikma Pharmaceuticals

16 1Hospira, Inc.

17 3Inibsa Hospital, Slu

18 4Kyowa Kirin

19 1Leman Skl Sa

20 3Meitheal Pharmaceuticals

21 2Nishchay Pharmaceuticals Pvt. Ltd.

22 1P & D Pharmaceuticals Limited

23 3RK Pharma

24 3Regulix Gmbh

25 3Substipharm

26 1Sunovion Pharmaceuticals

27 1Teva Pharmaceutical Industries

28 2UroGen Pharma

29 1Viatris

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PharmaCompass

01

Mitomycin

Brand Name : Mitomycin-C 2mg

Dosage Form : INJ

Dosage Strength : 2mg

Packaging : 1X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Aspen API Comapny Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual Boothmedac CDMO: Tailored CDMO services for injectables in syringes, cartridges & vials – aseptic, reliable, flexible and a solution ahead.

Regulatory Info : Prescription

Registration Country : Estonia

Mitomycin

Brand Name : Mitomycin Medac

Dosage Form : Powder For Intravesical Solution/Solution For Injection

Dosage Strength : 1mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

Company Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNaprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.

Regulatory Info :

Registration Country : India

Mitomycin

Brand Name :

Dosage Form : Lyophilised Injection

Dosage Strength : 2MG/Vial

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Company Banner

04

Mitomycin

Brand Name : Mitomycin-C 10 mg

Dosage Form : INJ

Dosage Strength : 10mg

Packaging : 1X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Aspen API Comapny Banner

05

  • fda
  • EDQM
  • WHO-GMP

Virtual Boothmedac CDMO: Tailored CDMO services for injectables in syringes, cartridges & vials – aseptic, reliable, flexible and a solution ahead.

Regulatory Info : Prescription

Registration Country : Estonia

Mitomycin

Brand Name : Mitomycin Medac

Dosage Form : Powder And Solvent For Intravesical Solution

Dosage Strength : 40mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

Company Banner

06

  • fda
  • EDQM
  • WHO-GMP

Virtual Boothmedac CDMO: Tailored CDMO services for injectables in syringes, cartridges & vials – aseptic, reliable, flexible and a solution ahead.

Regulatory Info : Authorized

Registration Country : Spain

Mitomycin

Brand Name : Mitomycin Medac

Dosage Form : Powder For Intravesical Solution And Injectable Solution

Dosage Strength : 20MG

Packaging :

Approval Date : 13-01-2017

Application Number : 81601

Regulatory Info : Authorized

Registration Country : Spain

Company Banner

07

  • fda
  • EDQM
  • WHO-GMP

Virtual Boothmedac CDMO: Tailored CDMO services for injectables in syringes, cartridges & vials – aseptic, reliable, flexible and a solution ahead.

Regulatory Info : Authorized

Registration Country : Spain

Mitomycin

Brand Name : Mitomycin Medac

Dosage Form : Powder For Intravesical Solution And Injectable Solution

Dosage Strength : 40MG

Packaging :

Approval Date : 13-01-2017

Application Number : 81602

Regulatory Info : Authorized

Registration Country : Spain

Company Banner

08

  • fda
  • EDQM
  • WHO-GMP

Virtual Boothmedac CDMO: Tailored CDMO services for injectables in syringes, cartridges & vials – aseptic, reliable, flexible and a solution ahead.

Regulatory Info : Authorized

Registration Country : Spain

Mitomycin

Brand Name : Mitomycin Medac

Dosage Form : Powder For Intravesical Solution And Injectable Solution

Dosage Strength : 2MG

Packaging :

Approval Date : 13-01-2017

Application Number : 81599

Regulatory Info : Authorized

Registration Country : Spain

Company Banner

09

  • fda
  • EDQM
  • WHO-GMP

Virtual Boothmedac CDMO: Tailored CDMO services for injectables in syringes, cartridges & vials – aseptic, reliable, flexible and a solution ahead.

Regulatory Info : Authorized

Registration Country : Spain

Mitomycin

Brand Name : Mitomycin Medac

Dosage Form : Powder For Intravesical Solution And Injectable Solution

Dosage Strength : 10MG

Packaging :

Approval Date : 13-01-2017

Application Number : 81600

Regulatory Info : Authorized

Registration Country : Spain

Company Banner

10

  • fda
  • EDQM
  • WHO-GMP

Virtual Boothmedac CDMO: Tailored CDMO services for injectables in syringes, cartridges & vials – aseptic, reliable, flexible and a solution ahead.

Regulatory Info : Prescription

Registration Country : Denmark

Mitomycin

Brand Name : Mitomycin “Medac.”

Dosage Form : Powder For Injection

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 14-07-2016

Application Number : 28105338113

Regulatory Info : Prescription

Registration Country : Denmark

Company Banner

11

  • fda
  • EDQM
  • WHO-GMP

Virtual Boothmedac CDMO: Tailored CDMO services for injectables in syringes, cartridges & vials – aseptic, reliable, flexible and a solution ahead.

Regulatory Info : Prescription

Registration Country : Denmark

Mitomycin

Brand Name : Mitomycin “Medac.”

Dosage Form : Powder And Solvent For Intravesical Solution

Dosage Strength : 40mg

Packaging :

Approval Date : 14-07-2016

Application Number : 28105337913

Regulatory Info : Prescription

Registration Country : Denmark

Company Banner

12

  • fda
  • EDQM
  • WHO-GMP

Virtual Boothmedac CDMO: Tailored CDMO services for injectables in syringes, cartridges & vials – aseptic, reliable, flexible and a solution ahead.

Regulatory Info : Approved

Registration Country : Sweden

Mitomycin

Brand Name : Mitomycin Medac

Dosage Form : Solution For Injection

Dosage Strength : 40mg

Packaging :

Approval Date : 08-01-2016

Application Number : 2.01E+13

Regulatory Info : Approved

Registration Country : Sweden

Company Banner

13

  • fda
  • EDQM
  • WHO-GMP

Virtual Boothmedac CDMO: Tailored CDMO services for injectables in syringes, cartridges & vials – aseptic, reliable, flexible and a solution ahead.

Regulatory Info : Deregistered

Registration Country : Sweden

Mitomycin

Brand Name : Mitomycin Medac

Dosage Form : Solution For Injection

Dosage Strength : 20mg

Packaging :

Approval Date : 08-01-2016

Application Number : 2.01E+13

Regulatory Info : Deregistered

Registration Country : Sweden

Company Banner

14

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNaprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.

Regulatory Info :

Registration Country : India

Mitomycin

Brand Name :

Dosage Form : Lyophilised Injection

Dosage Strength : 10MG/Vial

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Company Banner

15

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNaprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.

Regulatory Info :

Registration Country : India

Mitomycin

Brand Name :

Dosage Form : Lyophilised Injection

Dosage Strength : 20MG/Vial

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Company Banner

16

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNaprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.

Regulatory Info :

Registration Country : India

Mitomycin

Brand Name :

Dosage Form : Lyophilised Injection

Dosage Strength : 40MG/Vial

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Company Banner

17

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

MITOMYCIN

Brand Name : MUTAMYCIN

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1982-01-01

Application Number : 50450

Regulatory Info : DISCN

Registration Country : USA

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18

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

MITOMYCIN

Brand Name : MUTAMYCIN

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1982-01-01

Application Number : 50450

Regulatory Info : DISCN

Registration Country : USA

blank

19

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

MITOMYCIN

Brand Name : MITOSOL

Dosage Form : FOR SOLUTION;TOPICAL

Dosage Strength : 0.2MG/VIAL

Packaging :

Approval Date : 2012-02-07

Application Number : 22572

Regulatory Info : RX

Registration Country : USA

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20

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

MITOMYCIN

Brand Name : MITOZYTREX

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 2002-11-14

Application Number : 50763

Regulatory Info : DISCN

Registration Country : USA

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