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01 2Dr. Reddy's Laboratories

02 1Intas Pharmaceuticals

03 1Lotus Pharmaceutical

04 1Lupin Ltd

05 15Novartis Pharmaceuticals Corporation

06 1Novartis South Africa (Pty) Ltd

07 1Teva Pharmaceutical Industries

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Regulatory Info : RX

Registration Country : USA

MIDOSTAURIN

Brand Name : MIDOSTAURIN

Dosage Form : CAPSULE;ORAL

Dosage Strength : 25MG

Packaging :

Approval Date : 2024-06-28

Application Number : 215921

Regulatory Info : RX

Registration Country : USA

Dr Reddy Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Regulatory Info :

Registration Country : India

Midostaurin

Brand Name : Midostaurin

Dosage Form : Oral

Dosage Strength : 25 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Dr Reddy Company Banner

03

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Midostaurin

Brand Name :

Dosage Form : Soft Gelatin Capsule

Dosage Strength : 25MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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04

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

MIDOSTAURIN

Brand Name : MIDOSTAURIN

Dosage Form : CAPSULE;ORAL

Dosage Strength : 25MG

Packaging :

Approval Date :

Application Number : 215834

Regulatory Info :

Registration Country : USA

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06

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

MIDOSTAURIN

Brand Name : RYDAPT

Dosage Form : CAPSULE;ORAL

Dosage Strength : 25MG

Packaging :

Approval Date : 2017-04-28

Application Number : 207997

Regulatory Info : RX

Registration Country : USA

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07

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Midostaurin

Brand Name : Rydapt

Dosage Form : Capsule

Dosage Strength : 25mg

Packaging :

Approval Date : 18/09/2017

Application Number : 20160726000013

Regulatory Info : Approved

Registration Country : Sweden

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08

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Midostaurin

Brand Name : Rydapt

Dosage Form : Soft Capsule

Dosage Strength : 25mg

Packaging :

Approval Date : 04/05/2017

Application Number : 66310

Regulatory Info : Allowed

Registration Country : Switzerland

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09

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Midostaurin

Brand Name : Rydapt

Dosage Form : Capsule

Dosage Strength : 25mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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10

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Midostaurin

Brand Name : Rydapt

Dosage Form : Capsule

Dosage Strength : 25mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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11

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Midostaurin

Brand Name : Rydapt

Dosage Form : Capsule

Dosage Strength : 25mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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12

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Midostaurin

Brand Name : Rydapt

Dosage Form : Soft Capsule

Dosage Strength : 25MG

Packaging :

Approval Date : 30-10-2017

Application Number : 1171218001

Regulatory Info : Authorized

Registration Country : Spain

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13

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

MIDOSTAURIN

Brand Name : RYDAPT

Dosage Form : CAPSULE

Dosage Strength : 25MG

Packaging : 56/112

Approval Date :

Application Number : 2466236

Regulatory Info : Prescription

Registration Country : Canada

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14

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Midostaurin

Brand Name : Rydapt

Dosage Form :

Dosage Strength :

Packaging : 112

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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15

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Midostaurin

Brand Name : Rydapt

Dosage Form :

Dosage Strength :

Packaging : 56

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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16

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Midostaurin

Brand Name : Rydapt

Dosage Form :

Dosage Strength :

Packaging : 112

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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17

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Midostaurin

Brand Name : Rydapt

Dosage Form :

Dosage Strength :

Packaging : 112

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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18

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Midostaurin

Brand Name : Rydapt

Dosage Form :

Dosage Strength :

Packaging : 112

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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19

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

MIDOSTAURIN

Brand Name : MIDOSTAURIN

Dosage Form : CAPSULE;ORAL

Dosage Strength : 25MG

Packaging :

Approval Date : 2024-04-29

Application Number : 216076

Regulatory Info : DISCN

Registration Country : USA

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20

Novartis South Africa (Pty) Ltd

Country
SCOPE Summit
Not Confirmed
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Novartis South Africa (Pty) Ltd

Country
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SCOPE Summit
Not Confirmed

Midostaurin

Brand Name : Sotauric 25mg

Dosage Form : CAP

Dosage Strength : 25mg

Packaging : 56X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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