Esomeprazole Magnesium Trihydrate | 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

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

France

Regulatory Info :

Registration Country : Switzerland

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.

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

Interphex

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

PharmaVenue

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

Interphex

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

Iran Expo

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

Interphex

Not Confirmed

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 #5N-12

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

PharmaVenue

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

Octavius Pharma Pvt. Ltd

MAGHREB PHARMA

Stand #B09

Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

India

Regulatory Info :

Registration Country : India

Brand Name : Esomeprazole Magnesium Trihydrate

Dosage Form : Pellets/Micro pellets for capsules

Dosage Strength : 8.5%

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Product Web Link

11

Pharmathen SA

Greece

Interphex

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

12

Strides Pharma Science

CPhI WW Frankfurt

Booth # 9.1F6 & 9.1G41

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

13

Towa Pharmaceutical

Japan

euroPLX 88 Lisbon

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

14

Bal Pharma

Interphex

Not Confirmed

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

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 : 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

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

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 : ROW

Registration Country : India

Brand Name :

Dosage Form : Powder for Oral Suspension

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : ROW

Registration Country : India

21

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 : ROW

Registration Country : India

Brand Name :

Dosage Form : Powder for Oral Suspension

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : ROW

Registration Country : India

22

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 : ROW

Registration Country : India

Brand Name :

Dosage Form : Powder for Oral Suspension

Dosage Strength : 40MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : ROW

Registration Country : India

23

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 : ROW

Registration Country : India

Brand Name :

Dosage Form : Delayed Release Capsule

Dosage Strength : 25.82%

Packaging :

Approval Date :

Application Number :

Regulatory Info : ROW

Registration Country : India

24

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 :

Dosage Form : Delayed Release Pellets

Dosage Strength : 23.21%

Packaging :

Approval Date :

Application Number :

Regulatory Info : US

Registration Country : India

25

Sanofi

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

26

Sanofi

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

27

Sanofi

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

28

Sanofi

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

29

Sanofi

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

30

Sanofi

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

France

Regulatory Info :

Registration Country : Switzerland