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List of All Manufacturers & Suppliers of Dolutegravir And Rilpivirine Licensing, EU CTD Dossiers, Marketing Authorizations, Finished Dosage Formulations listed on PharmaCompass.com

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01 2Aspen Pharmacare Holdings

02 2Strides Pharma Science

03 1Adcock Ingram

04 4Aurobindo Pharma Limited

05 1Austell Laboratories

06 3Cipla

07 10Cipla Medpro South Africa

08 6Emcure Pharmaceuticals

09 2GSK

10 11Hetero Drugs

11 1Kiara Health

12 2Laurus Generics

13 2Laurus Labs

14 8Macleods Pharmaceuticals Limited

15 1Micro Labs Limited

16 2Novagen Pharma

17 1Orbit Lifescience

18 1Pfizer Inc

19 3RANBAXY LABORATORIES LIMITED

20 1Shanghai Desano Bio-Pharmaceutical

21 14Viatris

22 26ViiV Healthcare

23 1Xixia Pharmaceuticals (Pty) Ltd

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PharmaCompass

01

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AAPS 2024
Not Confirmed

Dolutegravir

Brand Name : Gradovir

Dosage Form : TAB

Dosage Strength : 50mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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02

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info :

Registration Country : India

Dolutegravir Sodium

Brand Name :

Dosage Form : Tablet

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Strides Pharma Science

03

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AAPS 2024
Not Confirmed

Dolutegravir

Brand Name : Vulante

Dosage Form : FCT

Dosage Strength : 50mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

04

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info : Generic

Registration Country : South Africa

Dolutegravir

Brand Name : Lendofil

Dosage Form : FCT

Dosage Strength : 50mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Strides Pharma Science

05

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

DOLUTEGRAVIR SODIUM

Brand Name : DOLUTEGRAVIR SODIUM

Dosage Form : TABLET;ORAL

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number : 208355

Regulatory Info :

Registration Country : USA

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06

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

DOLUTEGRAVIR SODIUM

Brand Name : DOLUTEGRAVIR SODIUM

Dosage Form : TABLET;ORAL

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number : 209658

Regulatory Info :

Registration Country : USA

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07

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

DOLUTEGRAVIR SODIUM

Brand Name : DOLUTEGRAVIR SODIUM

Dosage Form : TABLET;ORAL

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number : 210812

Regulatory Info :

Registration Country : USA

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08

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

Brand Name : DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

Dosage Form : TABLET;ORAL

Dosage Strength : 50MG/300MG/300MG

Packaging :

Approval Date :

Application Number : 211868

Regulatory Info :

Registration Country : USA

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09

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

Brand Name : DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

Dosage Form : TABLET;ORAL

Dosage Strength : 50MG; 300MG;300MG

Packaging :

Approval Date :

Application Number : 210787

Regulatory Info :

Registration Country : USA

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10

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

DOLUTEGRAVIR SODIUM

Brand Name : DOLUTEGRAVIR SODIUM

Dosage Form : TABLET; ORAL

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number : 210963

Regulatory Info :

Registration Country : USA

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11

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

Brand Name : DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

Dosage Form : TABLET;ORAL

Dosage Strength : 50MG/300MG/300MG

Packaging :

Approval Date :

Application Number : 210796

Regulatory Info :

Registration Country : USA

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12

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

DOLUTEGRAVIR SODIUM

Brand Name : DOLUTEGRAVIR SODIUM

Dosage Form : TABLET;ORAL

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number : 212179

Regulatory Info :

Registration Country : USA

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13

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

DOLUTEGRAVIR SODIUM

Brand Name : DOLUTEGRAVIR SODIUM

Dosage Form : TABLET;ORAL

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number : 209602

Regulatory Info :

Registration Country : USA

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AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

Brand Name : DOLUTEGRAVIR, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE

Dosage Form : TABLET;ORAL

Dosage Strength : 50MG;300MG;300MG

Packaging :

Approval Date :

Application Number : 209670

Regulatory Info :

Registration Country : USA

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AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

DOLUTEGRAVIR SODIUM

Brand Name : TIVICAY

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 50MG BASE

Packaging :

Approval Date : 2013-08-12

Application Number : 204790

Regulatory Info : RX

Registration Country : USA

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16

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

DOLUTEGRAVIR SODIUM

Brand Name : TIVICAY

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 10MG BASE

Packaging :

Approval Date : 2016-06-09

Application Number : 204790

Regulatory Info : DISCN

Registration Country : USA

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AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

DOLUTEGRAVIR SODIUM

Brand Name : TIVICAY

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 25MG BASE

Packaging :

Approval Date : 2016-06-09

Application Number : 204790

Regulatory Info : DISCN

Registration Country : USA

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18

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE

Brand Name : TRIUMEQ

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 600MG BASE;EQ 50MG BASE;300MG

Packaging :

Approval Date : 2014-08-22

Application Number : 205551

Regulatory Info : RX

Registration Country : USA

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19

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE

Brand Name : JULUCA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 50MG BASE;EQ 25MG BASE

Packaging :

Approval Date : 2017-11-21

Application Number : 210192

Regulatory Info : RX

Registration Country : USA

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AAPS 2024
Not Confirmed
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AAPS 2024
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DOLUTEGRAVIR SODIUM; LAMIVUDINE

Brand Name : DOVATO

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 50MG BASE;300MG

Packaging :

Approval Date : 2019-04-08

Application Number : 211994

Regulatory Info : RX

Registration Country : USA

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