Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
01 5Granules India Limited
02 4Dr. Reddy's Laboratories
03 8Alfred E Tiefenbacher GmbH
04 4Pharmathen SA
05 1Actavis Inc
06 4Amneal Deutschland GmbH
07 2Annora Pharma
08 2Apotex Inc
09 4Assia Chemical Industries Ltd
10 6DelNova Healthcare
11 4Hetero Drugs
12 2Mirpharm
13 16Novartis Pharmaceuticals Australia Pty Limited
14 15Novartis Pharmaceuticals Corporation
15 2Novartis South Africa (Pty) Ltd
16 3Teva Pharmaceutical Industries
01 2FCT
02 4FOR SUSPENSION;ORAL
03 12Film Coated Tablet
04 1Filmtabl
05 5Filmtable
06 3Immediate Release Tablet
07 4Oral Solid Dosage Form
08 2Powder for Oral Suspension
09 2Suspension
10 4TABLET
11 4TABLET; ORAL
12 17TABLET;ORAL
13 6Tablet
14 16Blank
01 1DISCN
02 8EU Dossier Readiness-Q2 2019
03 2Originator
04 4Prescription
05 16RX
06 2US, ROW
07 3US, ROW, EU
08 4USA
09 42Blank
01 4ALVAIZ
02 2APO-ELTROMBOPAG
03 8ELTROMBOPAG
04 6ELTROMBOPAG OLAMINE
05 5PROMACTA
06 2PROMACTA KIT
07 4Promacta
08 2Promacta Kit
09 2REVOLADE
10 22Revolade
11 1Revolade 25 mg
12 1Revolade 50 mg
13 23Blank
01 16Australia
02 4Canada
03 8Germany
04 4Greece
05 15India
06 2Russia
07 2South Africa
08 6Switzerland
09 25USA
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info : US, ROW
Registration Country : India
Brand Name :
Dosage Form : Powder for Oral Suspension
Dosage Strength : 25MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : US, ROW
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Oral Solid Dosage Form
Dosage Strength : 12.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q2 2019
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 12.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q2 2019
Registration Country : Germany
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : USA
Registration Country : Greece
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 12.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : USA
Registration Country : Greece
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info : US, ROW
Registration Country : India
Brand Name :
Dosage Form : Powder for Oral Suspension
Dosage Strength : 12.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : US, ROW
Registration Country : India
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info : US, ROW, EU
Registration Country : India
Brand Name :
Dosage Form : Immediate Release Tablet
Dosage Strength : 25MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : US, ROW, EU
Registration Country : India
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info : US, ROW, EU
Registration Country : India
Brand Name :
Dosage Form : Immediate Release Tablet
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : US, ROW, EU
Registration Country : India
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info : US, ROW, EU
Registration Country : India
Brand Name :
Dosage Form : Immediate Release Tablet
Dosage Strength : 75MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : US, ROW, EU
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Oral Solid Dosage Form
Dosage Strength : 25MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Oral Solid Dosage Form
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Oral Solid Dosage Form
Dosage Strength : 75MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q2 2019
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 25MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q2 2019
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q2 2019
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q2 2019
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q2 2019
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 75MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q2 2019
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q2 2019
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 12.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q2 2019
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q2 2019
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 25MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q2 2019
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q2 2019
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q2 2019
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q2 2019
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 75MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q2 2019
Registration Country : Germany
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : USA
Registration Country : Greece
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 25MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : USA
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : USA
Registration Country : Greece
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : USA
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : USA
Registration Country : Greece
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 75MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : USA
Registration Country : Greece
Regulatory Info : RX
Registration Country : USA
Brand Name : ELTROMBOPAG OLAMINE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 12.5MG ACID
Packaging :
Approval Date : 2025-01-17
Application Number : 206788
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ELTROMBOPAG OLAMINE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 25MG ACID
Packaging :
Approval Date : 2025-01-17
Application Number : 206788
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ELTROMBOPAG OLAMINE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 50MG ACID
Packaging :
Approval Date : 2025-01-17
Application Number : 206788
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ELTROMBOPAG OLAMINE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 75MG ACID
Packaging :
Approval Date : 2025-01-17
Application Number : 206788
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : PROMACTA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 25MG ACID
Packaging :
Approval Date : 2008-11-20
Application Number : 22291
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : PROMACTA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 50MG ACID
Packaging :
Approval Date : 2008-11-20
Application Number : 22291
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : PROMACTA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 75MG ACID
Packaging :
Approval Date : 2009-09-08
Application Number : 22291
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : PROMACTA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 12.5MG ACID
Packaging :
Approval Date : 2011-10-20
Application Number : 22291
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : PROMACTA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 2012-11-16
Application Number : 22291
Regulatory Info : DISCN
Registration Country : USA
