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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 1Accord Healthcare Ireland Ltd

08 2Accord Healthcare Ltd.

09 2Accord Healthcare Slu

10 2Actavis Group PTC ehf (1)

11 1Actavis Group PTC ehf   

12 1Actavis Group Ptc Ehf.

13 1Altan Pharmaceuticals Sa

14 2Astellas Pharma GmbH

15 1Astellas Pharma Gmbh

16 1Baxter Sl

17 2Chemi Spa

18 2Cps Cito Pharma Services Gmbh

19 2EG SpA

20 1Elc Group Sro

21 1Eugia Pharma (Malta) Limited

22 1Fresenius Kabi Ab

23 1Fresenius Kabi Espa?a, Sau

24 1Fresenius Kabi Italia S.r.l

25 1Glenmark Arzneimittel Gmbh

26 1Hikma Farmaceutica (Portugal) Sa

27 1Intas Pharmaceuticals Limited

28 2MEDAC GMBH

29 1Mylan Ire Healthcare Ltd

30 1Mylan Pharmaceuticals Sl

31 1Orifarm Ab

32 1Pharmaand Gmbh

33 1SEACROSS PHARMACEUTICALS

34 1Sandoz A/S

35 2Sandoz Pharmaceuticals Ag

36 2Swan Pond Investments Limited

37 2The Fresenius Kabi Oncology Plc

38 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

CTAD25
Not Confirmed
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CTAD25
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

CTAD25
Not Confirmed
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CTAD25
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

CTAD25
Not Confirmed
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CTAD25
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

CTAD25
Not Confirmed
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CTAD25
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

CTAD25
Not Confirmed
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CTAD25
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

CTAD25
Not Confirmed
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CTAD25
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
CTAD25
Not Confirmed
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EG SpA

Country
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CTAD25
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
CTAD25
Not Confirmed
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EG SpA

Country
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CTAD25
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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