Esomeprazole Magnesium Dihydrate | All | Licensing, EU CTD Dossiers, Formulation Suppliers

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

India

Regulatory Info : RX

Registration Country : USA

Brand Name : ESOMEPRAZOLE MAGNESIUM

Dosage Form : CAPSULE, DELAYED REL PELLETS;ORAL

Dosage Strength : EQ 20MG BASE

Packaging :

Approval Date : 2023-10-18

Application Number : 217427

Regulatory Info : RX

Registration Country : USA

02

Sanofi

BOS Manchester

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

France

Regulatory Info :

Registration Country : Switzerland

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Brand Name : Esomeprazole Zentiva

Dosage Form : Kaps

Dosage Strength : 20mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Portfolio PDF

Product Web Link

03

Aspen Pharmacare Holdings

South Africa

BOS Manchester

Not Confirmed

South Africa

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Aspepraz 40mg Injection

Dosage Form : INJ

Dosage Strength : 40mg

Packaging : 5X10mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Website

Corporate PDF

04

Athena Pharmaceutiques

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

France

Regulatory Info :

Registration Country : France

Brand Name :

Dosage Form : Enteric Coated Capsule

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : France

05

Orion Corporation

Finland

BOS Manchester

Not Confirmed

Finland

Regulatory Info :

Registration Country : Sweden

esomeprazolmagnesium

Brand Name : Esomeprazol Orion

Dosage Form : ENTEROTABLETT

Dosage Strength : 20 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Portfolio PDF

Product Web Link

Website

Corporate PDF

06

Temad Co

Iran

BOS Manchester

Not Confirmed

Temad- We think of world-class quality.

Iran

Regulatory Info :

Registration Country : Iran

Brand Name :

Dosage Form : Capsule

Dosage Strength : 40MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Iran

07

Cohance Lifesciences

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

India

Regulatory Info :

Registration Country : India

Brand Name :

Dosage Form : Delayed Release Pellet

Dosage Strength : 22.5%

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

08

Dr. Reddy's Laboratories

Booth #RH.E02

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

India

Regulatory Info : RX

Registration Country : USA

Brand Name : ESOMEPRAZOLE MAGNESIUM

Dosage Form : CAPSULE, DELAYED REL PELLETS;ORAL

Dosage Strength : EQ 20MG BASE

Packaging :

Approval Date : 2015-09-25

Application Number : 78279

Regulatory Info : RX

Registration Country : USA

09

Ethypharm

CPhI WW Frankfurt

Booth #5.0D100

Ethypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.

France

Regulatory Info : RX

Registration Country : USA

Brand Name : ESOMEPRAZOLE MAGNESIUM

Dosage Form : CAPSULE, DELAYED REL PELLETS;ORAL

Dosage Strength : EQ 20MG BASE

Packaging :

Approval Date : 2021-03-31

Application Number : 90841

Regulatory Info : RX

Registration Country : USA

10

Pharmathen SA

Greece

BOS Manchester

Not Confirmed

Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Greece

Regulatory Info : EU Approved

Registration Country : Greece

Brand Name :

Dosage Form : Powder For Solution For Injection/Infusion

Dosage Strength : 40MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU Approved

Registration Country : Greece

Portfolio PDF

11

Strides Pharma Science

Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

India

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Fluxtrin 20

Dosage Form : TAB

Dosage Strength : 20mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

12

Towa Pharmaceutical

Japan

BOS Manchester

Not Confirmed

Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.

Japan

Regulatory Info :

Registration Country : Italy

Brand Name : ESOMEPRAZOLE PENSA PHARMA

Dosage Form : Gastro-Resistant Hard Capsules

Dosage Strength : 20 mg

Packaging : 14 UNITS 20 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

Portfolio PDF

Product Web Link

13

Bal Pharma

Booth #5.I21

Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.

India

Regulatory Info :

Registration Country : India

Brand Name : Besomep

Dosage Form : Tablet

Dosage Strength : 40MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

14

Granules India Limited

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

India

Regulatory Info : RX

Registration Country : USA

Brand Name : ESOMEPRAZOLE MAGNESIUM

Dosage Form : CAPSULE, DELAYED REL PELLETS;ORAL

Dosage Strength : EQ 40MG BASE

Packaging :

Approval Date : 2023-10-18

Application Number : 217427

Regulatory Info : RX

Registration Country : USA

15

Granules India Limited

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

India

Regulatory Info : US

Registration Country : India

Brand Name : Esomeprazole DR Pellets

Dosage Form : Pellets

Dosage Strength : 23.21%

Packaging :

Approval Date :

Application Number :

Regulatory Info : US

Registration Country : India

16

Granules India Limited

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

India

Regulatory Info : US, ROW, EU

Registration Country : India

Brand Name :

Dosage Form : Delayed Release Capsule

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : US, ROW, EU

Registration Country : India

17

Granules India Limited

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

India

Regulatory Info : US, ROW, EU

Registration Country : India

Brand Name :

Dosage Form : Delayed Release Capsule

Dosage Strength : 40MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : US, ROW, EU

Registration Country : India

18

Granules India Limited

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

India

Regulatory Info : US, ROW

Registration Country : India

Brand Name :

Dosage Form : Capsule

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : US, ROW

Registration Country : India

19

Granules India Limited

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

India

Regulatory Info : US, ROW

Registration Country : India

Brand Name :

Dosage Form : Capsule

Dosage Strength : 40MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : US, ROW

Registration Country : India

20

Sanofi

BOS Manchester

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

France

Regulatory Info :

Registration Country : Switzerland

Brand Name : Esomeprazole Zentiva

Dosage Form : Kaps

Dosage Strength : 20mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Portfolio PDF

Product Web Link

21

Sanofi

BOS Manchester

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

France

Regulatory Info :

Registration Country : Switzerland

Brand Name : Esomeprazole Zentiva

Dosage Form : Kaps

Dosage Strength : 20mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Portfolio PDF

Product Web Link

22

Sanofi

BOS Manchester

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

France

Regulatory Info :

Registration Country : Switzerland

Brand Name : Esomeprazole Zentiva

Dosage Form : Kaps

Dosage Strength : 20mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Portfolio PDF

Product Web Link

23

Sanofi

BOS Manchester

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

France

Regulatory Info :

Registration Country : Switzerland

Brand Name : Esomeprazole Zentiva

Dosage Form : Kaps

Dosage Strength : 40mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Portfolio PDF

Product Web Link

24

Sanofi

BOS Manchester

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

France

Regulatory Info :

Registration Country : Switzerland

Brand Name : Esomeprazole Zentiva

Dosage Form : Kaps

Dosage Strength : 40mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Portfolio PDF

Product Web Link

25

Sanofi

BOS Manchester

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

France

Regulatory Info :

Registration Country : Switzerland

Brand Name : Esomeprazole Zentiva

Dosage Form : Kaps

Dosage Strength : 40mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Portfolio PDF

Product Web Link

26

Sanofi

BOS Manchester

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

France

Regulatory Info :

Registration Country : Switzerland

Brand Name : Esomeprazole Zentiva

Dosage Form : Kaps

Dosage Strength : 40mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Portfolio PDF

Product Web Link

27

Athena Pharmaceutiques

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

France

Regulatory Info :

Registration Country : France

Brand Name :

Dosage Form : Enteric Coated Capsule

Dosage Strength : 40MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : France

28

Orion Corporation

Finland

BOS Manchester

Not Confirmed

Finland

Regulatory Info :

Registration Country : Sweden

esomeprazolmagnesium

Brand Name : Esomeprazol Orion

Dosage Form : ENTEROTABLETT

Dosage Strength : 40 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Portfolio PDF

Product Web Link

Website

Corporate PDF

29

Temad Co

Iran

BOS Manchester

Not Confirmed

Temad- We think of world-class quality.

Iran

Regulatory Info :

Registration Country : Iran

Brand Name :

Dosage Form : Pellet

Dosage Strength : 22.5%

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Iran

30

Dr. Reddy's Laboratories

Booth #RH.E02

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

India

Regulatory Info : RX

Registration Country : USA