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

Client Email

Product

Obeticholic Acid
7-Ketolithocholic Acid
CAS 1516887-33-4
CAS 915038-26-5
CAS 459789-99-2
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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Obeticholic Acid

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

30 API Suppliers, 11 USDMF, 6 EU WC, 11 NDC API, 25 Listed Suppliers, $ API Reference Price

30 API Suppliers
11 USDMF
6 EU WC
11 NDC API
25 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

31 Drugs in Development

31 Drugs in Development

PRICE INFORMATION

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

API Reference Price
API Exports
API Imports
FDF Imports

INTERMEDIATES

17 API Suppliers

17 API Suppliers

FINISHED DOSAGE FORMULATIONS

21 FDF Dossiers, 9 FDA Orange Book, 4 Europe, 2 Canada, 3 Australia, 3 Listed Dossiers

21 FDF Dossiers
9 FDA Orange Book
4 Europe
2 Canada
3 Australia
3 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 2 DKSH, 7 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Aeon Procare, 3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 BASF, 5 Corel Pharma Chem, 3 DFE Pharma, 6 Gangwal Chemicals, 3 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 6 Kerry, 7 Microlex e.U, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 1 Pluviaendo, 3 Prachin Chemical, 11 Roquette, 2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 3 Vasa Pharmachem

1 SPI Pharma
2 DKSH
7 Gangwal Healthcare
1 Nanjing Well Pharmaceutical
1 Aeon Procare
3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
1 BASF
5 Corel Pharma Chem
3 DFE Pharma
6 Gangwal Chemicals
3 Ideal Cures Pvt Ltd
1 Ingredion Pharma Solutions
6 Kerry
7 Microlex e.U
1 Novo Excipients
2 Pharmatrans-Sanaq
1 Pluviaendo
3 Prachin Chemical
11 Roquette
2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
10 Sigachi Industries
3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

21 Fillers, Diluents & Binders, 20 Coating Systems & Additives, 15 Disintegrants & Superdisintegrants, 14 Direct Compression, 14 Lubricants & Glidants, 11 Thickeners and Stabilizers, 9 Controlled & Modified Release, 8 Co-Processed Excipients, 6 Granulation, 5 Film Formers & Plasticizers, 3 Taste Masking, 2 Topical, 2 Coloring Agents, 2 Chewable & Orodispersible Aids, 2 Parenteral, 1 API Stability Enhancers, 1 Rheology Modifiers, 1 Emulsifying Agents

21 Fillers, Diluents & Binders
20 Coating Systems & Additives
15 Disintegrants & Superdisintegrants
14 Direct Compression
14 Lubricants & Glidants
11 Thickeners and Stabilizers
9 Controlled & Modified Release
8 Co-Processed Excipients
6 Granulation
5 Film Formers & Plasticizers
3 Taste Masking
2 Topical
2 Coloring Agents
2 Chewable & Orodispersible Aids
2 Parenteral
1 API Stability Enhancers
1 Rheology Modifiers
1 Emulsifying Agents

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 68 NEWS #PharmaBuzz

3 DATA COMPILATION #PharmaFlow
68 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 4 Finished Drug Prices

1 US Medicaid Prescriptions
4 Finished Drug Prices

MARKET PLACE

10 APIs, 3 FDF Dossiers

10 APIs
3 FDF Dossiers

PATENTS & EXCLUSIVITIES

14 US Patents

14 US Patents

$ API Ref.Price (USD/KG) : 9,835 Xls

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11 All

01 1Biophore India Pharmaceuticals Pvt Ltd

02 1Moehs Iberica

03 1Alembic Pharmaceuticals Limited

04 1BrightGene Bio-Medical Technology Co.,Ltd

05 1Changzhou Pharmaceutical Factory

06 1Hetero Drugs

07 1Industriale Chimica

08 1Kaifeng Pharmaceutical Group Co., Ltd

09 1MSN Laboratories

10 1Optimus Pharma

11 1Solara Active Pharma Sciences

filter Subject Reset all filters

11 All

01 11OBETICHOLIC ACID

filter Country Reset all filters

11 All

01 3China

02 6India

03 1Italy

04 1Spain

filter Status Reset all filters

11 All

01 11Active

filter GDUFA DMF Review Reset all filters

11 All

01 6Complete

02 5Blank

API Suppliers
USDMF
EU WC
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

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Digital Content

Obeticholic Acid

GDUFA

DMF Review : Complete

Rev. Date : 2020-02-10

Pay. Date : 2019-12-30

DMF Number : 34413

Submission : 2019-12-27

Status : Active

Type : II

Product Web Link

Digital Content

02

Moehs Iberica Sl

CPhI Worldwide, Milan

Moehs Group, a reference company in the production of pharmaceutical active ingredients.

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Contact Supplier

Digital Content

Obeticholic Acid

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 38221

Submission : 2023-03-27

Status : Active

Type : II

Product Web Link

Digital Content

03

Alembic Pharmaceuticals Ltd

USDMF

Formnext Forum

Not Confirmed

03

Alembic Pharmaceuticals Ltd

Formnext Forum

Not Confirmed

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Digital Content

Obeticholic Acid

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 34333

Submission : 2019-12-11

Status : Active

Type : II

Product Web Link

Digital Content

04

Brightgene Bio-medical Technology Co...

USDMF

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Not Confirmed

04

Brightgene Bio-medical Technology Co...

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Digital Content

Obeticholic Acid

GDUFA

DMF Review : Complete

Rev. Date : 2022-01-31

Pay. Date : 2021-09-16

DMF Number : 36292

Submission : 2021-09-29

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

05

Changzhou Pharmaceutical Factory

USDMF

Formnext Forum

Not Confirmed

05

Changzhou Pharmaceutical Factory

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Digital Content

Obeticholic Acid

GDUFA

DMF Review : Complete

Rev. Date : 2023-02-15

Pay. Date : 2023-01-17

DMF Number : 37355

Submission : 2022-08-15

Status : Active

Type : II

Product Web Link

Digital Content

06

Hetero Labs Ltd

USDMF

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Not Confirmed

06

Hetero Labs Ltd

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Not Confirmed

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Digital Content

Obeticholic Acid

GDUFA

DMF Review : Complete

Rev. Date : 2020-02-13

Pay. Date : 2019-11-13

DMF Number : 34282

Submission : 2019-11-13

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Industriale Chimica Srl

USDMF

Formnext Forum

Not Confirmed

07

Industriale Chimica Srl

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Digital Content

Obeticholic Acid

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 33776

Submission : 2019-06-05

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Msn Life Sciences Private Ltd

USDMF

Formnext Forum

Not Confirmed

08

Msn Life Sciences Private Ltd

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Not Confirmed

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Digital Content

Obeticholic Acid

GDUFA

DMF Review : Complete

Rev. Date : 2019-08-01

Pay. Date : 2019-07-08

DMF Number : 33610

Submission : 2019-02-28

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

09

Optimus Drugs Private Ltd

USDMF

Formnext Forum

Not Confirmed

09

Optimus Drugs Private Ltd

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Not Confirmed

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Digital Content

Obeticholic Acid

GDUFA

DMF Review : Complete

Rev. Date : 2019-12-26

Pay. Date : 2019-11-06

DMF Number : 33960

Submission : 2019-11-07

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

10

Solara Active Pharma Sciences Ltd

USDMF

Formnext Forum

Not Confirmed

10

Solara Active Pharma Sciences Ltd

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Digital Content

Obeticholic Acid

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 34561

Submission : 2020-02-14

Status : Active

Type : II

Product Web Link

Digital Content

1
2

Obeticholic Acid Manufacturers | Traders | Suppliers

Obeticholic Acid Manufacturers, Traders, Suppliers 1

34

We have 11 companies offering Obeticholic Acid

Get in contact with the supplier of your choice:

Biophore India Pharmaceuticals Pvt Ltd
Moehs Iberica
Alembic Pharmaceuticals Limited
BrightGene Bio-Medical Technology Co.,Ltd
Changzhou Pharmaceutical Factory
Hetero Drugs
Industriale Chimica
Kaifeng Pharmaceutical Group Co., Ltd
MSN Laboratories
Optimus Pharma
Solara Active Pharma Sciences

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