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List of Drug Master Files (DMF) of COMPLERA Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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Product

COMPLERA
Tenofovir Disoproxil Fumarate
Rilpivirine Hydrochloride
USDMF

Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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xyz-pharma-m-2024-09-09

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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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xyz-pharma-m-2024-09-09

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COMPLERA

ACCESS ALL DATA, CHEMISTRY

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Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

31 API Suppliers, 17 USDMF, 2 JDMF, 14 EU WC, 6 KDMF, 17 NDC API, 16 Listed Suppliers, $ API Reference Price

31 API Suppliers
17 USDMF
2 JDMF
14 EU WC
6 KDMF
17 NDC API
16 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

28 Drugs in Development

28 Drugs in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Exports, FDF Imports

API Reference Price
API Exports
API Imports
FDF Exports
FDF Imports

INTERMEDIATES

1 API Suppliers

1 API Suppliers

FINISHED DOSAGE FORMULATIONS

171 FDF Dossiers, 52 FDA Orange Book, 32 Europe, 24 Canada, 52 South Africa, 11 Listed Dossiers

171 FDF Dossiers
52 FDA Orange Book
32 Europe
24 Canada
52 South Africa
11 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 200MG;EQ 25MG BASE;300MG, TABLET;ORAL - 150MG;150MG;200MG;300MG, TABLET;ORAL - 150MG;150MG;200MG;EQ 10MG BASE, TABLET;ORAL - 120MG;EQ 15MG BASE, TABLET;ORAL - 200MG;EQ 25MG BASE, TABLET;ORAL - 200MG;EQ 25MG BASE;EQ 25MG BASE, TABLET;ORAL - EQ 30MG BASE;120MG;EQ 15MG BASE, TABLET;ORAL - EQ 50MG BASE;200MG;EQ 25MG BASE, CAPSULE;ORAL - 200MG, TABLET;ORAL - 100MG;150MG, TABLET;ORAL - 133MG;200MG, TABLET;ORAL - 167MG;250MG, TABLET;ORAL - 200MG;300MG

TABLET;ORAL - 200MG;EQ 25MG BASE;300MG
TABLET;ORAL - 150MG;150MG;200MG;300MG
TABLET;ORAL - 150MG;150MG;200MG;EQ 10MG BASE
TABLET;ORAL - 120MG;EQ 15MG BASE
TABLET;ORAL - 200MG;EQ 25MG BASE
TABLET;ORAL - 200MG;EQ 25MG BASE;EQ 25MG BASE
TABLET;ORAL - EQ 30MG BASE;120MG;EQ 15MG BASE
TABLET;ORAL - EQ 50MG BASE;200MG;EQ 25MG BASE
CAPSULE;ORAL - 200MG
TABLET;ORAL - 100MG;150MG
TABLET;ORAL - 133MG;200MG
TABLET;ORAL - 167MG;250MG
TABLET;ORAL - 200MG;300MG

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 4 SPI Pharma, 2 Seqens, 8 DKSH, 1 Jai Radhe Sales, 1 Boai NKY Pharmaceuticals Ltd, 12 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 4 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 26 BASF, 10 Corel Pharma Chem, 5 DFE Pharma, 2 Finar, 8 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 31 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 2 Nomisma Healthcare, 3 Novo Excipients, 2 Pharmatrans-Sanaq, 6 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 16 Roquette, 9 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

69 Fillers, Diluents & Binders, 53 Coating Systems & Additives, 33 Controlled & Modified Release, 31 Direct Compression, 24 Thickeners and Stabilizers, 22 Granulation, 22 Disintegrants & Superdisintegrants, 18 Solubilizers, 16 Topical, 16 Lubricants & Glidants, 14 Co-Processed Excipients, 12 Parenteral, 12 Film Formers & Plasticizers, 11 Taste Masking, 9 Empty Capsules, 7 Chewable & Orodispersible Aids, 6 Emulsifying Agents, 5 API Stability Enhancers, 5 Coloring Agents, 4 Vegetarian Capsules, 3 Surfactant & Foaming Agents, 3 Rheology Modifiers

69 Fillers, Diluents & Binders
53 Coating Systems & Additives
33 Controlled & Modified Release
31 Direct Compression
24 Thickeners and Stabilizers
22 Granulation
22 Disintegrants & Superdisintegrants
18 Solubilizers
16 Topical
16 Lubricants & Glidants
14 Co-Processed Excipients
12 Parenteral
12 Film Formers & Plasticizers
11 Taste Masking
9 Empty Capsules
7 Chewable & Orodispersible Aids
6 Emulsifying Agents
5 API Stability Enhancers
5 Coloring Agents
4 Vegetarian Capsules
3 Surfactant & Foaming Agents
3 Rheology Modifiers

DIGITAL CONTENT

6 DATA COMPILATION #PharmaFlow, 3 STOCK RECAP #PipelineProspector, 191 NEWS #PharmaBuzz

6 DATA COMPILATION #PharmaFlow
3 STOCK RECAP #PipelineProspector
191 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

5 US Medicaid Prescriptions, 29 Finished Drug Prices, 55 Annual Reports

5 US Medicaid Prescriptions
29 Finished Drug Prices
55 Annual Reports

MARKET PLACE

8 APIs, 9 FDF Dossiers

8 APIs
9 FDF Dossiers

PATENTS & EXCLUSIVITIES

111 US Patents, 11 US Exclusivities, 2 Health Canada Patents

111 US Patents
11 US Exclusivities
2 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 USP, 4 Others

3 USP
4 Others

$ API Ref.Price (USD/KG) : 396 Xls

Filters

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17 All

01 1Arene Lifesciences

02 1Aurobindo Pharma Limited

03 1Cipla

04 1Emcure Pharmaceuticals

05 1HONOUR LAB LTD

06 2Hetero Drugs

07 1Laurus Labs

08 1Lupin Ltd

09 1Macleods Pharmaceuticals Limited

10 1RANBAXY LABORATORIES LIMITED

11 1Shanghai Desano Bio-Pharmaceutical

12 1Shijiazhuang Lonzeal Pharmac.Co. ltd

13 3Viatris

14 1Vivin Drugs

filter Subject Reset all filters

17 All

01 11EMTRICITABINE

02 1EMTRICITABINE (NON-STERILE) DRUG SUBSTANCE

03 2EMTRICITABINE (PROCESS-II)

04 1EMTRICITABINE (PROCESS-III)

05 1EMTRICITABINE DRUG SUBSTANCE

06 1EMTRICITABINE USP

filter Country Reset all filters

17 All

01 2China

02 12India

03 3U.S.A

filter Status Reset all filters

17 All

01 13Active

02 4Inactive

filter GDUFA DMF Review Reset all filters

17 All

01 10Complete

02 7Blank

API Suppliers
USDMF
JDMF
EU WC
KDMF
NDC API
Listed Suppliers

List of Suppliers

Product Main Page

01

Apitoria Pharma Private Ltd

USDMF

Formnext Forum

Not Confirmed

01

Apitoria Pharma Private Ltd

Formnext Forum

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

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Digital Content

Emtricitabine (non-sterile) Drug Substance

GDUFA

DMF Review : Complete

Rev. Date : 2017-12-01

Pay. Date : 2017-10-11

DMF Number : 20708

Submission : 2007-07-18

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

02

Cipla Ltd

USDMF

Formnext Forum

Not Confirmed

02

Cipla Ltd

Formnext Forum

Not Confirmed

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Digital Content

Emtricitabine

GDUFA

DMF Review : Complete

Rev. Date : 2014-05-24

Pay. Date : 2014-03-19

DMF Number : 19785

Submission : 2006-09-22

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Hetero Labs Ltd

USDMF

Formnext Forum

Not Confirmed

03

Hetero Labs Ltd

Formnext Forum

Not Confirmed

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Digital Content

Emtricitabine

GDUFA

DMF Review : Complete

Rev. Date : 2015-05-28

Pay. Date : 2015-05-14

DMF Number : 21612

Submission : 2008-05-09

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Laurus Labs Ltd

USDMF

Formnext Forum

Not Confirmed

04

Laurus Labs Ltd

Formnext Forum

Not Confirmed

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Digital Content

Emtricitabine

GDUFA

DMF Review : Complete

Rev. Date : 2013-05-09

Pay. Date : 2013-04-17

DMF Number : 23773

Submission : 2010-04-28

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

05

Lupin Ltd

USDMF

Formnext Forum

Not Confirmed

05

Lupin Ltd

Formnext Forum

Not Confirmed

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Digital Content

Emtricitabine

GDUFA

DMF Review : Complete

Rev. Date : 2013-10-10

Pay. Date : 2013-02-04

DMF Number : 22944

Submission : 2009-09-18

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

06

Macleods Pharmaceuticals Ltd

USDMF

Formnext Forum

Not Confirmed

06

Macleods Pharmaceuticals Ltd

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Digital Content

Emtricitabine

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 25001

Submission : 2011-05-31

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

07

Shanghai Desano Chemical Pharmaceuti...

USDMF

Formnext Forum

Not Confirmed

07

Shanghai Desano Chemical Pharmaceuti...

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Digital Content

Emtricitabine

GDUFA

DMF Review : Complete

Rev. Date : 2014-11-05

Pay. Date : 2013-02-07

DMF Number : 25617

Submission : 2011-12-19

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Mylan Laboratories Ltd

USDMF

Formnext Forum

Not Confirmed

08

Mylan Laboratories Ltd

Formnext Forum

Not Confirmed

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Digital Content

Emtricitabine (process-ii)

GDUFA

DMF Review : Complete

Rev. Date : 2014-02-05

Pay. Date : 2013-09-20

DMF Number : 27455

Submission : 2013-09-24

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Mylan Laboratories Ltd

USDMF

Formnext Forum

Not Confirmed

09

Mylan Laboratories Ltd

Formnext Forum

Not Confirmed

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Digital Content

Emtricitabine Usp

GDUFA

DMF Review : Complete

Rev. Date : 2013-05-21

Pay. Date : 2013-05-14

DMF Number : 19566

Submission : 2006-06-30

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Tianish Laboratories Private Ltd

USDMF

Formnext Forum

Not Confirmed

10

Tianish Laboratories Private Ltd

Formnext Forum

Not Confirmed

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Post an Enquiry

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Digital Content

Emtricitabine (process-iii)

GDUFA

DMF Review : Complete

Rev. Date : 2017-03-23

Pay. Date : 2017-03-01

DMF Number : 31457

Submission : 2017-03-10

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

1
2

COMPLERA Manufacturers | Traders | Suppliers

COMPLERA Manufacturers, Traders, Suppliers 1

28

We have 14 companies offering COMPLERA

Get in contact with the supplier of your choice:

Arene Lifesciences
Aurobindo Pharma Limited
Cipla
Emcure Pharmaceuticals
Hetero Drugs
HONOUR LAB LTD
Laurus Labs
Lupin Ltd
Macleods Pharmaceuticals Limited
RANBAXY LABORATORIES LIMITED
Shanghai Desano Bio-Pharmaceutical
Shijiazhuang Lonzeal Pharmac.Co. ltd
Viatris
Vivin Drugs

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