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

Client Email

Product

Selexipag
CAS 475086-75-0
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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Selexipag

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

27 API Suppliers, 10 USDMF, 4 EU WC, 1 KDMF, 6 NDC API, 18 Listed Suppliers, $ API Reference Price

27 API Suppliers
10 USDMF
4 EU WC
1 KDMF
6 NDC API
18 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports

API Reference Price
API Exports
API Imports

INTERMEDIATES

3 API Suppliers

3 API Suppliers

FINISHED DOSAGE FORMULATIONS

93 FDF Dossiers, 39 FDA Orange Book, 18 Europe, 8 Canada, 20 Australia, 8 Listed Dossiers

93 FDF Dossiers
39 FDA Orange Book
18 Europe
8 Canada
20 Australia
8 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 15 SPI Pharma, 3 DKSH, 6 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 BASF, 10 Corel Pharma Chem, 1 Finar, 5 Gangwal Chemicals, 4 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 14 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 8 Microlex e.U, 1 Novo Excipients, 3 Pluviaendo, 1 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 10 Roquette, 7 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 1 Sigachi Industries, 2 The Dow Chemical Company, 1 Valens Pharmachem, 1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

42 Coating Systems & Additives, 39 Fillers, Diluents & Binders, 19 Direct Compression, 17 Controlled & Modified Release, 14 Chewable & Orodispersible Aids, 14 Taste Masking, 9 Film Formers & Plasticizers, 9 Co-Processed Excipients, 9 Disintegrants & Superdisintegrants, 8 Lubricants & Glidants, 6 Thickeners and Stabilizers, 6 Granulation, 5 Parenteral, 5 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules, 4 API Stability Enhancers, 3 Emulsifying Agents, 3 Topical, 3 Solubilizers, 1 Rheology Modifiers

42 Coating Systems & Additives
39 Fillers, Diluents & Binders
19 Direct Compression
17 Controlled & Modified Release
14 Chewable & Orodispersible Aids
14 Taste Masking
9 Film Formers & Plasticizers
9 Co-Processed Excipients
9 Disintegrants & Superdisintegrants
8 Lubricants & Glidants
6 Thickeners and Stabilizers
6 Granulation
5 Parenteral
5 Empty Capsules
5 Coloring Agents
4 Vegetarian Capsules
4 API Stability Enhancers
3 Emulsifying Agents
3 Topical
3 Solubilizers
1 Rheology Modifiers

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 24 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
24 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 18 Finished Drug Prices, 8 Annual Reports

1 US Medicaid Prescriptions
18 Finished Drug Prices
8 Annual Reports

MARKET PLACE

3 APIs, 2 FDF Dossiers

3 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

52 US Patents, 8 Health Canada Patents

52 US Patents
8 Health Canada Patents

$ API Ref.Price (USD/KG) : 203,962 Xls

Filters

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10 All

01 1Biophore India Pharmaceuticals Pvt Ltd

02 1Alembic Pharmaceuticals Limited

03 1Apicore LLC

04 1Apotex Pharmachem

05 1HONOUR LAB LTD

06 1MSN Laboratories

07 3Maithri Drugs

08 1Zhejiang Huayi Pharmaceutical Co., Ltd.

filter Subject Reset all filters

10 All

01 5SELEXIPAG

02 1SELEXIPAG (AMORPHOUS)

03 1SELEXIPAG (FORM-I)

04 1SELEXIPAG (FORM-III)

05 1SELEXIPAG (FORM-P)

06 1SELEXIPAG-MANNITOL PREMIX

filter Country Reset all filters

10 All

01 1Canada

02 1China

03 8India

filter Status Reset all filters

10 All

01 10Active

filter GDUFA DMF Review Reset all filters

10 All

01 4Complete

02 6Blank

API Suppliers
USDMF
EU WC
KDMF
NDC API
Listed Suppliers

List of Suppliers

Product Main Page

01

Biophore India Pharmaceuticals Pvt L...

CPhI Worldwide, Milan

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

Contact Supplier

Contact Supplier

Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 33947

Submission : 2019-06-18

Status : Active

Type : II

Product Web Link

Digital Content

02

Alembic Pharmaceuticals Ltd

USDMF

Formnext Forum

Not Confirmed

02

Alembic Pharmaceuticals 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

GDUFA

DMF Review : Complete

Rev. Date : 2019-09-12

Pay. Date : 2019-07-16

DMF Number : 33974

Submission : 2019-07-30

Status : Active

Type : II

Product Web Link

Digital Content

03

Apicore Llc

USDMF

Formnext Forum

Not Confirmed

03

Apicore Llc

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.

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Digital Content

Selexipag-mannitol Premix

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 35163

Submission : 2020-09-09

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Apotex Pharmachem India Pvt Ltd

USDMF

Formnext Forum

Not Confirmed

04

Apotex Pharmachem India Pvt Ltd

Formnext Forum

Not Confirmed

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Digital Content

GDUFA

DMF Review : Complete

Rev. Date : 2019-06-06

Pay. Date : 2019-05-23

DMF Number : 33828

Submission : 2019-05-31

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

05

Honour Lab Ltd

USDMF

Formnext Forum

Not Confirmed

05

Honour Lab 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.

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Digital Content

Selexipag (amorphous)

GDUFA

DMF Review : Complete

Rev. Date : 2019-03-01

Pay. Date : 2019-01-28

DMF Number : 33061

Submission : 2018-12-31

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Maithri Drugs Private Ltd

USDMF

Formnext Forum

Not Confirmed

06

Maithri Drugs 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.

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Digital Content

Selexipag (form-p)

GDUFA

DMF Review : Complete

Rev. Date : 2019-04-23

Pay. Date : 2019-03-20

DMF Number : 32123

Submission : 2017-10-13

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

07

Maithri Drugs Private Ltd

USDMF

Formnext Forum

Not Confirmed

07

Maithri Drugs 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.

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Digital Content

Selexipag (form-iii)

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 36155

Submission : 2021-07-31

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

08

Maithri Drugs Private Ltd

USDMF

Formnext Forum

Not Confirmed

08

Maithri Drugs 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.

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Digital Content

Selexipag (form-i)

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 33561

Submission : 2019-03-07

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

09

Msn Laboratories Private Ltd

USDMF

Formnext Forum

Not Confirmed

09

Msn Laboratories 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

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 39699

Submission : 2024-03-29

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

10

Zhejiang Huayi Pharmaceutical Co Ltd

USDMF

Formnext Forum

Not Confirmed

10

Zhejiang Huayi Pharmaceutical Co 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

Post an Enquiry

Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 39287

Submission : 2023-12-18

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

Selexipag Manufacturers | Traders | Suppliers

Selexipag Manufacturers, Traders, Suppliers 1

25

We have 8 companies offering Selexipag

Get in contact with the supplier of your choice:

Biophore India Pharmaceuticals Pvt Ltd
Alembic Pharmaceuticals Limited
Apicore LLC
Apotex Pharmachem
HONOUR LAB LTD
Maithri Drugs
MSN Laboratories
Zhejiang Huayi Pharmaceutical Co., Ltd.

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