Italfarmaco S.p.a | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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Italfarmaco S.p.A
FDA Orange Book

Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.

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Kikkoman Biochemifa Company advances global health and safety through precision-driven innovation in biotech and food testing.

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Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

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TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.

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Moehs Group, a reference company in the production of pharmaceutical active ingredients.

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pharmacompass-2-m-2025-10-20

Italfarmaco S.p.A

VISIT THE VIRTUAL BOOTH, Contact Details

VISIT THE VIRTUAL BOOTH
Review portfolio & marketing content
CONTACT DETAILS
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EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

DIGITAL CONTENT

Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 24 News #PharmaBuzz

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

ACTIVE PHARMA INGREDIENTS

47 All APIs, 40 USDMF, 8 CEP/COS, 5 JDMF, 4 KDMF, 1 VMF, 2 Listed APIs

47 All APIs
40 USDMF
8 CEP/COS
5 JDMF
4 KDMF
1 VMF
2 Listed APIs

DEVELOPMENTS

17 Drugs in Development

17 Drugs in Development

FINISHED DOSAGE FORMULATIONS

214 FDF Dossiers, 12 FDA Orange Book, 202 Europe

214 FDF Dossiers
12 FDA Orange Book
202 Europe

SERVICES

Drug Product Manufacturing

Drug Product Manufacturing
- 2 Injectable / Parenteral

INSPECTIONS & REGISTRATIONS

7 FDA, 1 EDQM, 3 GDUFA

7 FDA
1 EDQM
3 GDUFA

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filter Active Ingredients Reset all filters

12 All

01 1DECITABINE

02 1GIVINOSTAT HYDROCHLORIDE

03 2GLATIRAMER ACETATE

04 1IBANDRONATE SODIUM

05 1RILUZOLE

06 6TEMOZOLOMIDE

filter Dosage Reset all filters

12 All

01 6CAPSULE;ORAL

02 2INJECTABLE;INTRAVENOUS

03 2INJECTABLE;SUBCUTANEOUS

04 2SUSPENSION;ORAL

filter Dosage Strength Reset all filters

12 All

01 1100MG

02 1140MG

03 1180MG

04 120MG

05 120MG/ML

06 1250MG

07 140MG/ML

08 150MG/10ML

09 150MG/VIAL

10 15MG

11 1EQ 3MG BASE/3ML

12 1EQ 8.86MG BASE/ML

filter Regulatory Info Reset all filters

12 All

01 12RX

List of Suppliers

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01

Brand Name : DECITABINE

AIChE Annual Meeting

Not Confirmed

Brand Name : DECITABINE

AIChE Annual Meeting

Not Confirmed

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RLD : No

TE Code : AP

Dosage Form : INJECTABLE; INTRAVENOUS

Proprietary Name : DECITABINE

Dosage Strength : 50MG/VIAL

Approval Date : 2017-09-22

Application Number : 206033

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

Product
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Stock Recap
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02

Brand Name : DUVYZAT

AIChE Annual Meeting

Not Confirmed

Brand Name : DUVYZAT

AIChE Annual Meeting

Not Confirmed

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RLD : Yes

TE Code :

GIVINOSTAT HYDROCHLORIDE

Italfarmaco S.p.A

Dosage Form : SUSPENSION; ORAL

Proprietary Name : DUVYZAT

Dosage Strength : EQ 8.86MG BASE/ML

Approval Date : 2024-03-21

Application Number : 217865

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Product
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03

Brand Name : GLATIRAMER ACETATE

AIChE Annual Meeting

Not Confirmed

Brand Name : GLATIRAMER ACETATE

AIChE Annual Meeting

Not Confirmed

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RLD : No

TE Code : AP

GLATIRAMER ACETATE

Dosage Form : INJECTABLE; SUBCUTANEOUS

Proprietary Name : GLATIRAMER ACETATE

Dosage Strength : 20MG/ML

Approval Date : 2025-05-07

Application Number : 208468

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

Product
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04

Brand Name : GLATIRAMER ACETATE

AIChE Annual Meeting

Not Confirmed

Brand Name : GLATIRAMER ACETATE

AIChE Annual Meeting

Not Confirmed

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Digital Content

RLD : No

TE Code : AP

GLATIRAMER ACETATE

Dosage Form : INJECTABLE; SUBCUTANEOUS

Proprietary Name : GLATIRAMER ACETATE

Dosage Strength : 40MG/ML

Approval Date : 2025-05-07

Application Number : 208468

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

Product
Web Link

Stock Recap
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05

Brand Name : IBANDRONATE SODIUM

AIChE Annual Meeting

Not Confirmed

Brand Name : IBANDRONATE SODIUM

AIChE Annual Meeting

Not Confirmed

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RLD : No

TE Code : AP

IBANDRONATE SODIUM

Dosage Form : INJECTABLE; INTRAVENOUS

Proprietary Name : IBANDRONATE SODIUM

Dosage Strength : EQ 3MG BASE/3ML

Approval Date : 2014-09-02

Application Number : 202235

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

Product
Web Link

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06

Brand Name : TIGLUTIK KIT

AIChE Annual Meeting

Not Confirmed

Brand Name : TIGLUTIK KIT

AIChE Annual Meeting

Not Confirmed

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RLD : Yes

TE Code : AB

Italfarmaco S.p.A

Dosage Form : SUSPENSION; ORAL

Proprietary Name : TIGLUTIK KIT

Dosage Strength : 50MG/10ML

Approval Date : 2018-09-05

Application Number : 209080

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Product
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07

Brand Name : TEMOZOLOMIDE

AIChE Annual Meeting

Not Confirmed

Brand Name : TEMOZOLOMIDE

AIChE Annual Meeting

Not Confirmed

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Digital Content

RLD : No

TE Code : AB

TEMOZOLOMIDE

Dosage Form : CAPSULE; ORAL

Proprietary Name : TEMOZOLOMIDE

Dosage Strength : 5MG

Approval Date : 2016-11-23

Application Number : 204639

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product
Web Link

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08

Brand Name : TEMOZOLOMIDE

AIChE Annual Meeting

Not Confirmed

Brand Name : TEMOZOLOMIDE

AIChE Annual Meeting

Not Confirmed

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Digital Content

RLD : No

TE Code : AB

TEMOZOLOMIDE

Dosage Form : CAPSULE; ORAL

Proprietary Name : TEMOZOLOMIDE

Dosage Strength : 20MG

Approval Date : 2016-11-23

Application Number : 204639

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product
Web Link

Stock Recap
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09

Brand Name : TEMOZOLOMIDE

AIChE Annual Meeting

Not Confirmed

Brand Name : TEMOZOLOMIDE

AIChE Annual Meeting

Not Confirmed

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Digital Content

RLD : No

TE Code : AB

TEMOZOLOMIDE

Dosage Form : CAPSULE; ORAL

Proprietary Name : TEMOZOLOMIDE

Dosage Strength : 100MG

Approval Date : 2016-11-23

Application Number : 204639

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product
Web Link

Stock Recap
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10

Brand Name : TEMOZOLOMIDE

AIChE Annual Meeting

Not Confirmed

Brand Name : TEMOZOLOMIDE

AIChE Annual Meeting

Not Confirmed

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Digital Content

RLD : No

TE Code : AB

TEMOZOLOMIDE

Dosage Form : CAPSULE; ORAL

Proprietary Name : TEMOZOLOMIDE

Dosage Strength : 140MG

Approval Date : 2016-11-23

Application Number : 204639

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product
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Stock Recap
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1
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Italfarmaco S.p.a is a supplier offers 1 products (APIs, Excipients or Intermediates).

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