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01 1Medac Gesellschaft F?r Klinische Spezialpr?parate Gmbh

02 1Medac Society For Clinical Specialty Preparations Mbh

03 2ACCORD HEALTHCARE LIMITED

04 3ASTELLAS PHARMA GmbH

05 3Accord Healthcare Ag

06 2Accord Healthcare Bv

07 2Accord Healthcare Ltd.

08 2Accord Healthcare Slu

09 2Actavis Group PTC ehf (1)

10 1Actavis Group Ptc Ehf.

11 1Altan Pharmaceuticals Sa

12 2Astellas Pharma GmbH

13 1Astellas Pharma Gmbh

14 1Baxter Sl

15 2Chemi Spa

16 2Cps Cito Pharma Services Gmbh

17 2EG SpA

18 1Elc Group Sro

19 1Eugia Pharma (Malta) Limited

20 1Fresenius Kabi Ab

21 1Fresenius Kabi Espa?a, Sau

22 1Glenmark Arzneimittel Gmbh

23 1Hikma Farmaceutica (Portugal) Sa

24 1Intas Pharmaceuticals Limited

25 2MEDAC GMBH

26 1Mylan Ire Healthcare Ltd

27 1Mylan Pharmaceuticals Sl

28 1Orifarm Ab

29 1Pharmaand Gmbh

30 1SEACROSS PHARMACEUTICALS

31 1Sandoz A/S

32 2Sandoz Pharmaceuticals Ag

33 2Swan Pond Investments Limited

34 2The Fresenius Kabi Oncology Plc

35 1Tillomed Spain Laboratories Sl

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PharmaCompass

01

  • 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

Bendamustine Hydrochloride

Brand Name : Bendamustine Medac

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 2.5mg/ml

Packaging :

Approval Date : 10/03/2016

Application Number : 20150730000024

Regulatory Info : Approved

Registration Country : Sweden

Company 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 : Cancelled

Registration Country : Spain

Bendamustine Hydrochloride

Brand Name : Bendamustina Medac

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 2.5MG

Packaging :

Approval Date : 2019-11-04

Application Number : 80255

Regulatory Info : Cancelled

Registration Country : Spain

Company Banner

03

OPRD
Not Confirmed
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OPRD
Not Confirmed

Bendamustine

Brand Name : Bendamustina

Dosage Form : Bendamustina 100Mg 5 Units Parenteral Use

Dosage Strength : 5 vials Chk 100 mg 2,5 mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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04

OPRD
Not Confirmed
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OPRD
Not Confirmed

Bendamustine

Brand Name : Bendamustina

Dosage Form : Bendamustina 25Mg 5 Units Parenteral Use

Dosage Strength : 5 Chk vials 25 mg 2.5 mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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05

OPRD
Not Confirmed
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OPRD
Not Confirmed

Bendamustine

Brand Name : Levact

Dosage Form : Bendamustina 100Mg 5 Units Parenteral Use

Dosage Strength : 5 VIALS EV 100 mg 2,5 mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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06

OPRD
Not Confirmed
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OPRD
Not Confirmed

Bendamustine

Brand Name : Levact

Dosage Form : Bendamustina 25Mg 20 Joined The Parenteral Use

Dosage Strength : 20 VIALS EV 25 mg 2.5 mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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07

OPRD
Not Confirmed
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OPRD
Not Confirmed

Bendamustine

Brand Name : Bendamustina

Dosage Form : Bendamustina 100Mg 5 Units Parenteral Use

Dosage Strength : 5 VIALS EV 100 mg 2,5 mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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08

OPRD
Not Confirmed
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OPRD
Not Confirmed

Bendamustine

Brand Name :

Dosage Form : FREEZE-DRIED POWDER

Dosage Strength : 100MG

Packaging : Vial

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : United Kingdom

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09

EG SpA

Country
OPRD
Not Confirmed
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EG SpA

Country
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OPRD
Not Confirmed

Bendamustine

Brand Name : Bendamustina

Dosage Form : Bendamustina 100Mg 5 Units Parenteral Use

Dosage Strength : 5 VIALS EV 100 mg 2,5 mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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10

EG SpA

Country
OPRD
Not Confirmed
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EG SpA

Country
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OPRD
Not Confirmed

Bendamustine

Brand Name : Bendamustina

Dosage Form : Bendamustina 25Mg 5 Units Parenteral Use

Dosage Strength : 5 VIALS EV 25 mg 2.5 mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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