Dolutegravir / rilpivirine | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Dolutegravir / Rilpivirine
South Africa

Evonik

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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.

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With Fermion, start the journey of your innovative API.

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Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.

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Temad- We think of world-class quality.

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Dolutegravir / rilpivirine

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ACTIVE PHARMA INGREDIENTS

59 API Suppliers, 26 USDMF, 14 EU WC, 2 KDMF, 12 NDC API, 36 Listed Suppliers, $ API Reference Price

59 API Suppliers
26 USDMF
14 EU WC
2 KDMF
12 NDC API
36 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

163 Drugs in Development

163 Drugs in Development

INTERMEDIATES

40 Intermediate Suppliers

40 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

128 FDF Dossiers, 30 FDA Orange Book, 27 Europe, 5 Canada, 1 Australia, 63 South Africa, 2 Listed Dossiers

128 FDF Dossiers
30 FDA Orange Book
27 Europe
5 Canada
1 Australia
63 South Africa
2 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 50MG BASE, TABLET;ORAL - EQ 600MG BASE;EQ 50MG BASE;300MG

TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 50MG BASE
TABLET;ORAL - EQ 600MG BASE;EQ 50MG BASE;300MG

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 Rochem International Inc, 15 SPI Pharma, 3 DKSH, 4 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 1 Pfanstiehl, 1 Kirsch Pharma, 3 Actylis, 1 Aeon Procare, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 20 BASF, 5 Corel Pharma Chem, 5 DFE Pharma, 1 Esteem Industries, 1 Finar, 7 Gangwal Chemicals, 2 Ideal Cures, 2 Ingredion Pharma Solutions, 14 Kerry, 2 Keval Exports, 12 Microlex e.U, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 13 Roquette, 2 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 3 Silverline Chemicals, 1 Ulanqab Kema New Material, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

56 Fillers, Diluents & Binders, 25 Direct Compression, 22 Granulation, 20 Coating Systems & Additives, 20 Disintegrants & Superdisintegrants, 18 Lubricants & Glidants, 16 Solubilizers, 15 Controlled & Modified Release, 15 Chewable & Orodispersible Aids, 15 Thickeners and Stabilizers, 12 Taste Masking, 12 Co-Processed Excipients, 11 Topical, 11 Parenteral, 5 Film Formers & Plasticizers, 3 Surfactant & Foaming Agents, 3 Coloring Agents, 2 Rheology Modifiers, 2 Emulsifying Agents, 2 API Stability Enhancers

56 Fillers, Diluents & Binders
25 Direct Compression
22 Granulation
20 Coating Systems & Additives
20 Disintegrants & Superdisintegrants
18 Lubricants & Glidants
16 Solubilizers
15 Controlled & Modified Release
15 Chewable & Orodispersible Aids
15 Thickeners and Stabilizers
12 Taste Masking
12 Co-Processed Excipients
11 Topical
11 Parenteral
5 Film Formers & Plasticizers
3 Surfactant & Foaming Agents
3 Coloring Agents
2 Rheology Modifiers
2 Emulsifying Agents
2 API Stability Enhancers

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 1 Stock Recap #PipelineProspector, 128 News #PharmaBuzz

1 Data Compilation #PharmaFlow
1 Stock Recap #PipelineProspector
128 News #PharmaBuzz

GLOBAL SALES INFORMATION

5 US Medicaid Prescriptions, 7 Regulatory FDF Prices, 58 Annual Reports

5 US Medicaid Prescriptions
7 Regulatory FDF Prices
58 Annual Reports

MARKET PLACE

9 APIs, 8 FDF Dossiers

9 APIs
8 FDF Dossiers

PATENTS & EXCLUSIVITIES

36 US Patents, 5 US Exclusivities, 17 Health Canada Patents

36 US Patents
5 US Exclusivities
17 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 Others

1 Others

$ API Ref.Price (USD/KG) : 417 Xls

Filters

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63 All

01 2Pharmacare Limited, Woodmead

02 1Adcock Ingram Limited

03 4Aurobindo Pharma (Pty) Ltd

04 1Austell Pharmaceuticals (Pty) Ltd

05 9Cipla Medpro (Pty) Ltd

06 2Cipla Medpro Manufacturing (Pty) Ltd

07 5Emcure Pharmaceuticals South Africa (Pty) Ltd

08 2GlaxoSmithKline South Africa (Pty) Limited

09 12Hetero Drugs South Africa (Pty) Ltd

10 1Kiara Health (PTY) LTD

11 3Macleods Pharmaceuticals SA (Pty) Ltd

12 6Mylan (Pty) Ltd

13 2Novagen Pharma (Pty) Ltd

14 1Pharma Dynamics (Pty) Ltd

15 4Ranbaxy Pharmaceuticals (Pty) Ltd

16 1Strides Pharma SA (Pty) Ltd

17 7Viatris Healthcare (Pty) Ltd

filter Active Ingredients Reset all filters

63 All

01 1DOLUTEGRAVIR

02 5Dolutegeravir

03 56Dolutegravir

04 1dolutegravir

filter Dosage Form Reset all filters

63 All

01 1DSP

02 1FCR

03 43FCT

04 3ODT

05 15TAB

filter Brand Name Reset all filters

63 All

01 1Acriptega

02 2Aedatri

03 1Altaeda

04 1Cagol

05 1Daliduo

06 1Dalimune

07 1Damicava

08 1Damicava Paed

09 1Divtrida

10 1Dolutegravir Mylan

11 1Dotenal

12 2Dovimil

13 1Envuteg

14 1Gradovir

15 2HETVIR 50

16 1Kavideza

17 1Kavmyl

18 1Komycitaf

19 1Kovatrax Tablets

20 2Lanograv

21 1Lavem

22 1Lendofil

23 1Lomida

24 3Luvigen

25 2Milutin

26 1Mylataf

27 1Myltega

28 2Myltega 10mg Dispersible Tablets

29 1Novalute

30 1Nuvaco

31 1OLEGRA

32 1Odystra

33 1Ranega

34 1Rarudine

35 2Reydin

36 1Stigra

37 1Syromak 10 ODT

38 1TEMILUR

39 1Tegem

40 1Telatri

41 1Temiv

42 1Tetrilune

43 1Tivicay 50mg

44 1Tladeez

45 1Tolevtri

46 1Trelavue

47 1VIDOTEG

48 3VOLUTRIP

49 2VUTERAR

50 1Viraten

51 1Vulante

List of Suppliers

Product Main Page

01

Pharmacare Limited, Woodmead

Pharma MES 2025

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Dolutegravir

Brand Name : Gradovir

Dosage Form : TAB

Dosage Strength : 50mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

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02

Pharmacare Limited, Woodmead

Pharma MES 2025

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Dolutegravir

Brand Name : Vulante

Dosage Form : FCT

Dosage Strength : 50mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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03

Adcock Ingram Limited

Pharma MES 2025

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Adcock Ingram Limited

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Regulatory Info : Generic

Registration Country : South Africa

Dolutegravir

Brand Name : Nuvaco

Dosage Form : FCT

Dosage Strength : 50mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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04

Aurobindo Pharma (Pty) Ltd

Pharma MES 2025

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Aurobindo Pharma (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Dolutegravir

Brand Name : VOLUTRIP

Dosage Form : TAB

Dosage Strength : 50mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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05

Aurobindo Pharma (Pty) Ltd

Pharma MES 2025

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Aurobindo Pharma (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Dolutegravir

Brand Name : VOLUTRIP

Dosage Form : TAB

Dosage Strength : 50mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

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06

Aurobindo Pharma (Pty) Ltd

Pharma MES 2025

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Aurobindo Pharma (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Dolutegravir

Brand Name : VOLUTRIP

Dosage Form : TAB

Dosage Strength : 50mg

Packaging : 90X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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07

Aurobindo Pharma (Pty) Ltd

Pharma MES 2025

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Aurobindo Pharma (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Dolutegravir

Brand Name : OLEGRA

Dosage Form : FCT

Dosage Strength : 50mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

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08

Austell Pharmaceuticals (Pty) Ltd

Pharma MES 2025

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Austell Pharmaceuticals (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Dolutegravir

Brand Name : Dotenal

Dosage Form : FCT

Dosage Strength : 50mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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09

Cipla Medpro Manufacturing (Pty) Ltd

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Pharma MES 2025

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Cipla Medpro Manufacturing (Pty) Ltd

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Registration Country : South Africa

Dolutegravir

Brand Name : Aedatri

Dosage Form : FCT

Dosage Strength : 50mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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10

Cipla Medpro Manufacturing (Pty) Ltd

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Pharma MES 2025

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Cipla Medpro Manufacturing (Pty) Ltd

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Pharma MES 2025

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Regulatory Info : Originator

Registration Country : South Africa

Dolutegravir

Brand Name : Aedatri

Dosage Form : FCT

Dosage Strength : 50mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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