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

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Darunavir
USDMF

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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Jai Radhe Sales is your partner for all your sourcing needs.

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xyz-pharma-m-2024-10-07

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Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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xyz-pharma-m-2024-10-07

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Darunavir

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

25 API Suppliers, 19 USDMF, 7 EU WC, 12 NDC API, 12 Listed Suppliers, $ API Reference Price

25 API Suppliers
19 USDMF
7 EU WC
12 NDC API
12 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

5 Drugs in Development

5 Drugs in Development

INTERMEDIATES

24 Intermediates Suppliers

24 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

106 FDF Dossiers, 51 FDA Orange Book, 24 Europe, 4 Canada, 4 Australia, 13 South Africa, 10 Listed Dossiers

106 FDF Dossiers
51 FDA Orange Book
24 Europe
4 Canada
4 Australia
13 South Africa
10 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 150MG;800MG, TABLET;ORAL - 150MG, TABLET;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 600MG, TABLET;ORAL - 75MG, TABLET;ORAL - 800MG

TABLET;ORAL - 150MG;800MG
TABLET;ORAL - 150MG
TABLET;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 600MG
TABLET;ORAL - 75MG
TABLET;ORAL - 800MG

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 1 STOCK RECAP #PipelineProspector, 58 NEWS #PharmaBuzz

2 DATA COMPILATION #PharmaFlow
1 STOCK RECAP #PipelineProspector
58 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

24 Finished Drug Prices, 16 Annual Reports

24 Finished Drug Prices
16 Annual Reports

MARKET PLACE

6 APIs, 3 FDF Dossiers

6 APIs
3 FDF Dossiers

PATENTS & EXCLUSIVITIES

50 US Patents, 26 Health Canada Patents

50 US Patents
26 Health Canada Patents

REF. STANDARDS & IMPURITIES

9 Others

9 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 952 Xls

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19 All

01 1Aurobindo Pharma Limited

02 3Cipla

03 2Hetero Drugs

04 1Innovare Labs

05 1Johnson & Johnson Innovative Medicine

06 1Laurus Labs

07 2Lupin Ltd

08 2MSN Laboratories

09 1Raks Pharma

10 2Viatris

11 2Zhejiang Jiuzhou Pharmaceutical

12 1Zydus Lifesciences

filter Subject Reset all filters

19 All

01 8DARUNAVIR

02 2DARUNAVIR (AMORPHOUS)

03 1DARUNAVIR (PROCESS-II)

04 1DARUNAVIR (R319064) DRUG SUBSTANCE

05 1DARUNAVIR AMORPHOUS

06 1DARUNAVIR AMORPHOUS (PROCESS-II)

07 1DARUNAVIR HYDRATE

08 1DARUNAVIR HYDRATE (PROCESS II)

09 1DARUNAVIR N-PROPANOLATE

10 1DARUNAVIR PROPYLENE GLYCOLATE

11 1DARUNAVIR [ROUTE CODE - "DI"]

filter Country Reset all filters

19 All

01 2China

02 14India

03 3U.S.A

filter Status Reset all filters

19 All

01 13Active

02 6Inactive

filter GDUFA DMF Review Reset all filters

19 All

01 9Complete

02 10Blank

List of Suppliers

Product Main Page

01

Apitoria Pharma Private Ltd

USDMF

Pharmtech & Ingredients

Not Confirmed

01

Apitoria Pharma Private Ltd

Pharmtech & Ingredients

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

Darunavir Propylene Glycolate

GDUFA

DMF Review : Complete

Rev. Date : 2017-05-23

Pay. Date : 2017-01-25

DMF Number : 31358

Submission : 2017-01-25

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

02

Cipla Ltd

USDMF

Pharmtech & Ingredients

Not Confirmed

02

Cipla Ltd

Pharmtech & Ingredients

Not Confirmed

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Digital Content

Darunavir Hydrate

GDUFA

DMF Review : Complete

Rev. Date : 2013-09-29

Pay. Date : 2013-09-20

DMF Number : 23661

Submission : 2010-07-06

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Cipla Ltd

USDMF

Pharmtech & Ingredients

Not Confirmed

03

Cipla Ltd

Pharmtech & Ingredients

Not Confirmed

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Digital Content

GDUFA

DMF Review : Complete

Rev. Date : 2013-09-29

Pay. Date : 2013-09-20

DMF Number : 23660

Submission : 2011-03-16

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Hetero Labs Ltd

USDMF

Pharmtech & Ingredients

Not Confirmed

04

Hetero Labs Ltd

Pharmtech & Ingredients

Not Confirmed

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Digital Content

Darunavir Amorphous

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 23854

Submission : 2010-06-02

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Janssen Pharmaceutica Nv

USDMF

Pharmtech & Ingredients

Not Confirmed

05

Janssen Pharmaceutica Nv

Pharmtech & Ingredients

Not Confirmed

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Digital Content

Darunavir (r319064) Drug Substance

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 18825

Submission : 2005-11-02

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Laurus Labs Ltd

USDMF

Pharmtech & Ingredients

Not Confirmed

06

Laurus Labs Ltd

Pharmtech & Ingredients

Not Confirmed

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Digital Content

GDUFA

DMF Review : Complete

Rev. Date : 2017-11-03

Pay. Date : 2016-12-20

DMF Number : 31198

Submission : 2017-10-24

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

07

Msn Life Sciences Private Ltd

USDMF

Pharmtech & Ingredients

Not Confirmed

07

Msn Life Sciences Private Ltd

Pharmtech & Ingredients

Not Confirmed

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Digital Content

Darunavir (amorphous)

GDUFA

DMF Review : Complete

Rev. Date : 2018-03-27

Pay. Date : 2018-03-14

DMF Number : 30882

Submission : 2016-10-05

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

08

Raks Pharma Pvt Ltd

USDMF

Pharmtech & Ingredients

Not Confirmed

08

Raks Pharma Pvt Ltd

Pharmtech & Ingredients

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

GDUFA

DMF Review : Complete

Rev. Date : 2017-01-19

Pay. Date : 2016-09-30

DMF Number : 30803

Submission : 2016-10-05

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

09

Tianish Laboratories Private Ltd

USDMF

Pharmtech & Ingredients

Not Confirmed

09

Tianish Laboratories Private Ltd

Pharmtech & Ingredients

Not Confirmed

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Digital Content

Darunavir (process-ii)

GDUFA

DMF Review : Complete

Rev. Date : 2016-07-19

Pay. Date : 2016-06-21

DMF Number : 30596

Submission : 2016-06-27

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Tianish Laboratories Private Ltd

USDMF

Pharmtech & Ingredients

Not Confirmed

10

Tianish Laboratories Private Ltd

Pharmtech & Ingredients

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.

Post an Enquiry

Post an Enquiry

Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 23873

Submission : 2010-06-10

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

1
2

Darunavir Manufacturers | Traders | Suppliers

Darunavir Manufacturers, Traders, Suppliers 1

79

We have 12 companies offering Darunavir

Get in contact with the supplier of your choice:

Aurobindo Pharma Limited
Cipla
Hetero Drugs
Innovare Labs
Johnson & Johnson Innovative Medicine
Laurus Labs
Lupin Ltd
MSN Laboratories
Raks Pharma
Viatris
Zhejiang Jiuzhou Pharmaceutical
Zydus Lifesciences

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