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Samsung Bioepis
FDF Dossiers

AMI Lifesciences is Driven by Chemistry. Powered by People.

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Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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pharmacompass-2-m-2025-08-25

Samsung Bioepis

VISIT THE VIRTUAL BOOTH, Contact Details

VISIT THE VIRTUAL BOOTH
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EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

DIGITAL CONTENT

Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 215 News #PharmaBuzz

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

DEVELOPMENTS

74 Drugs in Development

74 Drugs in Development

FINISHED DOSAGE FORMULATIONS

42 FDF Dossiers, 16 FDA Orange Book, 14 Europe, 12 Canada

42 FDF Dossiers
16 FDA Orange Book
14 Europe
12 Canada

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filter Active Ingredients Reset all filters

42 All

01 4ADALIMUMAB

02 1ADALIMUMAB-BWWD

03 1AFLIBERCEPT-YSZY

04 2Adalimumab

05 6Adalimumabum

06 2BEVACIZUMAB

07 4DENOSUMAB-DSSB

08 1ECULIZUMAB-AAGH

09 2ETANERCEPT

10 2ETANERCEPT-YKRO

11 5Etanercept

12 1INFLIXIMAB

13 1INFLIXIMAB-ABDA

14 1RANIBIZUMAB

15 1RANIBIZUMAB-NUNA

16 1Ranibizumab

17 2TRASTUZUMAB

18 2TRASTUZUMAB-DTTB

19 3USTEKINUMAB-TTWE

filter Applicant Reset all filters

42 All

01 16SAMSUNG BIOEPIS CO LTD

02 12SAMSUNG BIOEPIS CO., LTD

03 12Samsung Bioepis CH GmbH

04 2Samsung Bioepis NL B.V.

filter Dosage Form Reset all filters

42 All

01 8INJECTABLE;INJECTION

02 5INJECTABLE;SUBCUTANEOUS

03 1INJECTION;SOLUTION

04 4Inj L?s

05 8Inj Sol

06 3POWDER FOR SOLUTION

07 2POWDER;IV (INFUSION)

08 9SOLUTION

09 1Solution for injection in a pre-filled pen

10 1Solution for injection, solution in pre-filled syringe

filter Dosage Reset all filters

42 All

01 10.5MG(10MG/ML)

02 1100MG

03 1100MG/4ML

04 1100MG/VIAL

05 110MG/ML

06 1130MG/26ML(5MG/ML)

07 1150MG

08 1150MG/VIAL

09 12.3mg/0.23ml

10 125MG/0.5ML

11 125mg/0.5ml

12 12MG(0.05ML,40MG/ML)

13 1300 mg/30 mL (10 mg/mL)

14 240 mg

15 1400MG/16ML

16 240MG/0.4ML

17 340MG/0.8ML

18 640mg/0.8ml

19 1420MG

20 1440MG/VIAL

21 145MG/0.5ML

22 150MG/1ML

23 250MG/ML

24 450mg/ml

25 260MG/ML

26 270MG/ML

27 190MG/ML

filter Country Reset all filters

42 All

01 12Canada

02 2Norway

03 12Switzerland

04 16USA

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Brand Name : Imraldi

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Regulatory Info :

Registration Country : Norway

Samsung Bioepis

Dosage Form : Solution for injection, ...

Brand Name : Imraldi

Dosage Strength : 40 mg

Packaging : Pre-filled syringe 2 0.4ml, pcs

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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02

Brand Name : Imraldi

Coatings Trends

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Brand Name : Imraldi

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Digital Content

Regulatory Info :

Registration Country : Norway

Samsung Bioepis

Dosage Form : Solution for injection i...

Brand Name : Imraldi

Dosage Strength : 40 mg

Packaging : Pre-filled pen 2 0.4ml, pcs

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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03

Brand Name : HADLIMA

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Brand Name : HADLIMA

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Regulatory Info :

Registration Country : Canada

Samsung Bioepis

Dosage Form : SOLUTION

Brand Name : HADLIMA

Dosage Strength : 40MG/0.8ML

Packaging : 0.8ML

Approval Date :

Application Number : 2473097

Regulatory Info :

Registration Country : Canada

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04

Brand Name : HADLIMA PUSHTOUCH

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Regulatory Info :

Registration Country : Canada

Samsung Bioepis

Dosage Form : SOLUTION

Brand Name : HADLIMA PUSHTOUCH

Dosage Strength : 40MG/0.8ML

Packaging : 0.8ML

Approval Date :

Application Number : 2473100

Regulatory Info :

Registration Country : Canada

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Brand Name : HADLIMA PUSHTOUCH

Coatings Trends

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Regulatory Info :

Registration Country : Canada

Samsung Bioepis

Dosage Form : SOLUTION

Brand Name : HADLIMA PUSHTOUCH

Dosage Strength : 40MG/0.4ML

Packaging :

Approval Date :

Application Number : 2533480

Regulatory Info :

Registration Country : Canada

Product
Web Link

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06

Brand Name : HADLIMA

Coatings Trends

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Brand Name : HADLIMA

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Regulatory Info :

Registration Country : Canada

Samsung Bioepis

Dosage Form : SOLUTION

Brand Name : HADLIMA

Dosage Strength : 40MG/0.4ML

Packaging :

Approval Date :

Application Number : 2533472

Regulatory Info :

Registration Country : Canada

Product
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07

Brand Name : HADLIMA

Coatings Trends

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Brand Name : HADLIMA

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Regulatory Info :

Registration Country : USA

ADALIMUMAB-BWWD

Samsung Bioepis

Dosage Form : INJECTABLE;INJECTION

Brand Name : HADLIMA

Dosage Strength : 40MG/0.8ML

Packaging :

Approval Date :

Application Number : 761059

Regulatory Info :

Registration Country : USA

Product
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08

Brand Name : Imraldi

Coatings Trends

Not Confirmed

Brand Name : Imraldi

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Regulatory Info :

Registration Country : Switzerland

Adalimumabum

Samsung Bioepis

Dosage Form : Inj Sol

Brand Name : Imraldi

Dosage Strength : 40mg/0.8ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Product
Web Link

Stock Recap
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09

Brand Name : Imraldi

Coatings Trends

Not Confirmed

Brand Name : Imraldi

Coatings Trends

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Digital Content

Regulatory Info :

Registration Country : Switzerland

Adalimumabum

Samsung Bioepis

Dosage Form : Inj Sol

Brand Name : Imraldi

Dosage Strength : 40mg/0.8ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Product
Web Link

Stock Recap
#PipelineProspector

10

Brand Name : Imraldi

Coatings Trends

Not Confirmed

Brand Name : Imraldi

Coatings Trends

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

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Digital Content

Regulatory Info :

Registration Country : Switzerland

Adalimumabum

Samsung Bioepis

Dosage Form : Inj Sol

Brand Name : Imraldi

Dosage Strength : 40mg/0.8ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Product
Web Link

Stock Recap
#PipelineProspector

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