Taiho Pharmaceutical | EU CTD Dossiers | In | Out | Licensing | PharmaCompass.com

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Taiho Pharmaceutical
FDF Dossiers

LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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Munit offers scalable GMP micronization and particle size engineering to enhance drug solubility, bioavailability, and performance.

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pharmacompass-1-m-2025-11-03

Mission CDMO team brings reliability, resourcefulness, & responsiveness in executing your development project.

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Jai Radhe Sales is your partner for all your sourcing needs.

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Taiho Pharmaceutical

VISIT THE VIRTUAL BOOTH, Contact Details

VISIT THE VIRTUAL BOOTH
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CONTACT DETAILS
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EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

DIGITAL CONTENT

Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 50 News #PharmaBuzz

Interview #SpeakPharma
Vlog #PharmaReel
Data Compilation #PharmaFlow
50 News #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

11 All APIs, 10 USDMF, 2 KDMF

11 All APIs
10 USDMF
2 KDMF

DEVELOPMENTS

54 Drugs in Development

54 Drugs in Development

FINISHED DOSAGE FORMULATIONS

13 FDF Dossiers, 5 FDA Orange Book, 2 Europe, 6 Canada

13 FDF Dossiers
5 FDA Orange Book
2 Europe
6 Canada

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filter Active Ingredients Reset all filters

13 All

01 1CEDAZURIDINE

02 1CEDAZURIDINE; DECITABINE

03 1DECITABINE

04 2FUTIBATINIB

05 2Futibatinib

06 2TIPIRACIL (TIPIRACIL HYDROCHLORIDE)

07 2TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE

08 2TRIFLURIDINE

filter Applicant Reset all filters

13 All

01 5TAIHO ONCOLOGY

02 6TAIHO PHARMA CANADA, INC.

03 2Taiho Pharma Netherlands Bv

filter Dosage Form Reset all filters

13 All

01 2Film Coated Tablet

02 6TABLET

03 5TABLET;ORAL

filter Dosage Reset all filters

13 All

01 1100MG

02 1100MG;35MG

03 115MG

04 116MG

05 120MG

06 135MG

07 24MG

08 14mg

09 16.14MG

10 18.19MG

11 1EQ 6.14MG BASE;15MG

12 1EQ 8.19MG BASE;20MG

filter Country Reset all filters

13 All

01 6Canada

02 1Spain

03 1Sweden

04 5USA

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01

Brand Name : INQOVI

AAPS

Not Confirmed

Brand Name : INQOVI

AAPS

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Regulatory Info : Prescription

Registration Country : Canada

CEDAZURIDINE

Taiho Pharmaceutical

Dosage Form : TABLET

Brand Name : INQOVI

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number : 2501600

Regulatory Info : Prescription

Registration Country : Canada

Product
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02

Brand Name : INQOVI

AAPS

Not Confirmed

Brand Name : INQOVI

AAPS

Not Confirmed

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Regulatory Info : RX

Registration Country : USA

CEDAZURIDINE; DECITABINE

Taiho Pharmaceutical

Dosage Form : TABLET;ORAL

Brand Name : INQOVI

Dosage Strength : 100MG;35MG

Packaging :

Approval Date : 2020-07-07

Application Number : 212576

Regulatory Info : RX

Registration Country : USA

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03

Brand Name : INQOVI

AAPS

Not Confirmed

Brand Name : INQOVI

AAPS

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Regulatory Info : Prescription

Registration Country : Canada

Taiho Pharmaceutical

Dosage Form : TABLET

Brand Name : INQOVI

Dosage Strength : 35MG

Packaging :

Approval Date :

Application Number : 2501600

Regulatory Info : Prescription

Registration Country : Canada

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04

Brand Name : LYTGOBI

AAPS

Not Confirmed

Brand Name : LYTGOBI

AAPS

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Regulatory Info : RX

Registration Country : USA

FUTIBATINIB

Taiho Pharmaceutical

Dosage Form : TABLET;ORAL

Brand Name : LYTGOBI

Dosage Strength : 4MG

Packaging :

Approval Date : 2022-09-30

Application Number : 214801

Regulatory Info : RX

Registration Country : USA

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05

Brand Name : LYTGOBI

AAPS

Not Confirmed

Brand Name : LYTGOBI

AAPS

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Regulatory Info : RX

Registration Country : USA

FUTIBATINIB

Taiho Pharmaceutical

Dosage Form : TABLET;ORAL

Brand Name : LYTGOBI

Dosage Strength : 16MG

Packaging :

Approval Date : 2025-07-28

Application Number : 214801

Regulatory Info : RX

Registration Country : USA

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06

Brand Name : Lytgoby

AAPS

Not Confirmed

Brand Name : Lytgoby

AAPS

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Regulatory Info : Approved

Registration Country : Sweden

Futibatinib

Taiho Pharmaceutical

Dosage Form : Film Coated Tablet

Brand Name : Lytgoby

Dosage Strength : 4mg

Packaging :

Approval Date : 04/07/2023

Application Number : 20220504000014

Regulatory Info : Approved

Registration Country : Sweden

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07

Brand Name : Lytgobi

AAPS

Not Confirmed

Brand Name : Lytgobi

AAPS

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Regulatory Info : Authorized

Registration Country : Spain

Futibatinib

Taiho Pharmaceutical

Dosage Form : Film Coated Tablet

Brand Name : Lytgobi

Dosage Strength : 4MG

Packaging :

Approval Date : 2023-09-21

Application Number : 1231741001

Regulatory Info : Authorized

Registration Country : Spain

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08

Brand Name : LONSURF

AAPS

Not Confirmed

Brand Name : LONSURF

AAPS

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Regulatory Info : Prescription

Registration Country : Canada

TIPIRACIL (TIPIRACIL HYDROCHLORIDE)

Taiho Pharmaceutical

Dosage Form : TABLET

Brand Name : LONSURF

Dosage Strength : 6.14MG

Packaging : 20

Approval Date :

Application Number : 2472104

Regulatory Info : Prescription

Registration Country : Canada

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09

Brand Name : LONSURF

AAPS

Not Confirmed

Brand Name : LONSURF

AAPS

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Regulatory Info : Prescription

Registration Country : Canada

TIPIRACIL (TIPIRACIL HYDROCHLORIDE)

Taiho Pharmaceutical

Dosage Form : TABLET

Brand Name : LONSURF

Dosage Strength : 8.19MG

Packaging : 20

Approval Date :

Application Number : 2472112

Regulatory Info : Prescription

Registration Country : Canada

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10

Brand Name : LONSURF

AAPS

Not Confirmed

Brand Name : LONSURF

AAPS

Not Confirmed

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Regulatory Info : RX

Registration Country : USA

TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE

Taiho Pharmaceutical

Dosage Form : TABLET;ORAL

Brand Name : LONSURF

Dosage Strength : EQ 6.14MG BASE;15MG

Packaging :

Approval Date : 2015-09-22

Application Number : 207981

Regulatory Info : RX

Registration Country : USA

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1
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Contact Taiho Pharmaceutical and get a quotation

Taiho Pharmaceutical is a supplier offers 9 products (APIs, Excipients or Intermediates).

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