Dolutegravir | API DMFs | US Drug Master File (DMF) Details | Pharmacompass.com

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Dolutegravir
USDMF

Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

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AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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xyz-pharma-m-2024-10-07

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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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

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xyz-pharma-m-2024-10-07

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Dolutegravir

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

51 API Suppliers, 25 USDMF, 8 EU WC, 2 KDMF, 12 NDC API, 33 Listed Suppliers, $ API Reference Price

51 API Suppliers
25 USDMF
8 EU WC
2 KDMF
12 NDC API
33 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

23 Drugs in Development

23 Drugs in Development

INTERMEDIATES

38 API Suppliers

38 API Suppliers

FINISHED DOSAGE FORMULATIONS

105 FDF Dossiers, 28 FDA Orange Book, 10 Europe, 7 Canada, 1 Australia, 57 South Africa, 2 Listed Dossiers

105 FDF Dossiers
28 FDA Orange Book
10 Europe
7 Canada
1 Australia
57 South Africa
2 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 10MG BASE, TABLET;ORAL - EQ 25MG BASE, TABLET;ORAL - EQ 50MG BASE, TABLET;ORAL - EQ 600MG BASE;EQ 50MG BASE;300MG

TABLET;ORAL - EQ 10MG BASE
TABLET;ORAL - EQ 25MG BASE
TABLET;ORAL - EQ 50MG BASE
TABLET;ORAL - EQ 600MG BASE;EQ 50MG BASE;300MG

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 Rochem International Inc, 14 SPI Pharma, 2 Seqens, 3 DKSH, 2 Jai Radhe Sales, 4 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 11 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 3 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 20 BASF, 5 Corel Pharma Chem, 5 DFE Pharma, 1 Finar, 7 Gangwal Chemicals, 3 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 22 Kerry, 12 Microlex e.U, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 5 Pluviaendo, 4 Prachin Chemical, 13 Roquette, 2 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 2 Ulanqab Kema New Material, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

70 Fillers, Diluents & Binders, 33 Direct Compression, 22 Coating Systems & Additives, 20 Disintegrants & Superdisintegrants, 19 Lubricants & Glidants, 19 Granulation, 18 Thickeners and Stabilizers, 17 Co-Processed Excipients, 16 Controlled & Modified Release, 16 Solubilizers, 13 Chewable & Orodispersible Aids, 12 Parenteral, 11 Taste Masking, 10 Topical, 5 Film Formers & Plasticizers, 3 Coloring Agents, 3 API Stability Enhancers, 2 Rheology Modifiers, 2 Emulsifying Agents, 2 Surfactant & Foaming Agents

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

DIGITAL CONTENT

6 DATA COMPILATION #PharmaFlow, 2 STOCK RECAP #PipelineProspector, 125 NEWS #PharmaBuzz

6 DATA COMPILATION #PharmaFlow
2 STOCK RECAP #PipelineProspector
125 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 12 Finished Drug Prices, 32 Annual Reports

3 US Medicaid Prescriptions
12 Finished Drug Prices
32 Annual Reports

MARKET PLACE

8 APIs, 8 FDF Dossiers

8 APIs
8 FDF Dossiers

PATENTS & EXCLUSIVITIES

36 US Patents, 5 US Exclusivities, 1 Health Canada Patents

36 US Patents
5 US Exclusivities
1 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 Others

1 Others

$ API Ref.Price (USD/KG) : 435 Xls

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25 All

01 1Arene Lifesciences

02 1Aurobindo Pharma Limited

03 1Chongqing Carelife Pharmaceutical

04 1Chromo Laboratories

05 3Cipla

06 1Emcure Pharmaceuticals

07 2Hetero Drugs

08 3Laurus Labs

09 1Lek Pharmaceuticals

10 2Lupin Ltd

11 2MSN Laboratories

12 1Macleods Pharmaceuticals Limited

13 1Micro Labs Limited

14 1Shanghai Desano Chemical Pharmaceutical Co., Ltd.

15 1Styrax

16 2Viatris

17 1Viyash Life Sciences

filter Subject Reset all filters

25 All

01 17DOLUTEGRAVIR SODIUM

02 1DOLUTEGRAVIR SODIUM ( PROCESS B)

03 1DOLUTEGRAVIR SODIUM (FORM C)

04 1DOLUTEGRAVIR SODIUM (PROCESS A)

05 1DOLUTEGRAVIR SODIUM (PROCESS-2)

06 1DOLUTEGRAVIR SODIUM (PROCESS-3)

07 2DOLUTEGRAVIR SODIUM (PROCESS-II)

08 1DOLUTEGRAVIR SODIUM PROCESS A

filter Country Reset all filters

25 All

01 2China

02 20India

03 1Slovenia

04 2U.S.A

filter Status Reset all filters

25 All

01 25Active

filter GDUFA DMF Review Reset all filters

25 All

01 19Complete

02 6Blank

List of Suppliers

Product Main Page

01

Apitoria Pharma Private Ltd

USDMF

PackExpo

Not Confirmed

01

Apitoria Pharma Private Ltd

PackExpo

Not Confirmed

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.

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Digital Content

Dolutegravir Sodium

GDUFA

DMF Review : Complete

Rev. Date : 2015-01-08

Pay. Date : 2014-10-10

DMF Number : 28721

Submission : 2014-10-14

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

02

Cipla Ltd

USDMF

PackExpo

Not Confirmed

02

Cipla Ltd

PackExpo

Not Confirmed

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Digital Content

Dolutegravir Sodium (form C)

GDUFA

DMF Review : Complete

Rev. Date : 2017-03-01

Pay. Date : 2016-11-07

DMF Number : 31107

Submission : 2017-02-11

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Cipla Ltd

USDMF

PackExpo

Not Confirmed

03

Cipla Ltd

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Digital Content

Dolutegravir Sodium

GDUFA

DMF Review : Complete

Rev. Date : 2016-07-19

Pay. Date : 2016-05-16

DMF Number : 30055

Submission : 2016-03-17

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Hetero Labs Ltd

USDMF

PackExpo

Not Confirmed

04

Hetero Labs Ltd

PackExpo

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Digital Content

Dolutegravir Sodium

GDUFA

DMF Review : Complete

Rev. Date : 2016-07-19

Pay. Date : 2016-05-19

DMF Number : 30544

Submission : 2016-05-20

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Laurus Labs Ltd

USDMF

PackExpo

Not Confirmed

05

Laurus Labs Ltd

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Digital Content

Dolutegravir Sodium

GDUFA

DMF Review : Complete

Rev. Date : 2017-01-13

Pay. Date : 2016-09-19

DMF Number : 30935

Submission : 2016-09-28

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

06

Lek Pharmaceuticals Dd

USDMF

PackExpo

Not Confirmed

06

Lek Pharmaceuticals Dd

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Digital Content

Dolutegravir Sodium

GDUFA

DMF Review : Complete

Rev. Date : 2017-03-06

Pay. Date : 2016-11-25

DMF Number : 30933

Submission : 2016-12-19

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Micro Labs Ltd

USDMF

PackExpo

Not Confirmed

07

Micro Labs Ltd

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Digital Content

Dolutegravir Sodium

GDUFA

DMF Review : Complete

Rev. Date : 2017-01-19

Pay. Date : 2017-01-10

DMF Number : 31222

Submission : 2017-01-03

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Shanghai Desano Chemical Pharmaceuti...

USDMF

PackExpo

Not Confirmed

08

Shanghai Desano Chemical Pharmaceuti...

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Digital Content

Dolutegravir Sodium

GDUFA

DMF Review : Complete

Rev. Date : 2018-07-02

Pay. Date : 2018-03-05

DMF Number : 30365

Submission : 2016-02-03

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Tianish Laboratories Private Ltd

USDMF

PackExpo

Not Confirmed

09

Tianish Laboratories Private Ltd

PackExpo

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Digital Content

Dolutegravir Sodium

GDUFA

DMF Review : Complete

Rev. Date : 2016-01-26

Pay. Date : 2015-11-24

DMF Number : 30011

Submission : 2015-11-26

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Tianish Laboratories Private Ltd

USDMF

PackExpo

Not Confirmed

10

Tianish Laboratories Private Ltd

PackExpo

Not Confirmed

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Digital Content

Dolutegravir Sodium (process-ii)

GDUFA

DMF Review : Complete

Rev. Date : 2017-05-31

Pay. Date : 2017-05-11

DMF Number : 31209

Submission : 2016-12-15

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

1
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Dolutegravir Manufacturers | Traders | Suppliers

Dolutegravir Manufacturers, Traders, Suppliers 1

19

We have 17 companies offering Dolutegravir

Get in contact with the supplier of your choice:

Arene Lifesciences
Aurobindo Pharma Limited
Chongqing Carelife Pharmaceutical
Chromo Laboratories
Cipla
Emcure Pharmaceuticals
Hetero Drugs
Laurus Labs
Lek Pharmaceuticals
Lupin Ltd
Macleods Pharmaceuticals Limited
Micro Labs Limited
MSN Laboratories
Shanghai Desano Chemical Pharmaceutical Co., Ltd.
Styrax
Viatris
Viyash Life Sciences

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