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Approved Drug Products containing Obeticholic Acid listed in the FDA Orange Book. Original Data : FDA Website

Client Email

Product

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

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
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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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9 All

01 2APOTEX

02 2INTERCEPT PHARMS INC

03 2LUPIN LTD

04 2MSN

05 1OPTIMUS PHARMA PRIVATE LTD

filter Dosage Reset all filters

9 All

01 1TABLET; ORAL

02 8TABLET;ORAL

filter Regulatory Info Reset all filters

9 All

01 6DISCN

02 2RX

03 1Blank

filter Brand Name Reset all filters

9 All

01 7OBETICHOLIC ACID

02 2OCALIVA

filter RLD Reset all filters

9 All

01 6No

02 2Yes

03 1Blank

FDF Dossiers
FDA Orange Book
Europe
Canada
Australia
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01

APOTEX

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APOTEX

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RLD : No

TE Code :

OBETICHOLIC ACID

Brand Name : OBETICHOLIC ACID

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Approval Date : 2023-05-30

Application Number : 214862

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

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Digital Content

Corporate PDF

02

APOTEX

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APOTEX

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RLD : No

TE Code :

OBETICHOLIC ACID

Brand Name : OBETICHOLIC ACID

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2023-05-30

Application Number : 214862

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

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Corporate PDF

03

INTERCEPT PHARMS INC

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INTERCEPT PHARMS INC

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RLD : Yes

TE Code :

OBETICHOLIC ACID

Brand Name : OCALIVA

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Approval Date : 2016-05-27

Application Number : 207999

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

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04

INTERCEPT PHARMS INC

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RLD : Yes

TE Code :

OBETICHOLIC ACID

Brand Name : OCALIVA

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2016-05-27

Application Number : 207999

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

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Digital Content

05

LUPIN LTD

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LUPIN LTD

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RLD : No

TE Code :

OBETICHOLIC ACID

Brand Name : OBETICHOLIC ACID

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Approval Date : 2023-05-30

Application Number : 214980

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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06

LUPIN LTD

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RLD : No

TE Code :

OBETICHOLIC ACID

Brand Name : OBETICHOLIC ACID

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2023-05-30

Application Number : 214980

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product Web Link

Digital Content

Corporate PDF

07

MSN

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MSN

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RLD : No

TE Code :

OBETICHOLIC ACID

Brand Name : OBETICHOLIC ACID

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Approval Date : 2023-05-30

Application Number : 215017

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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Digital Content

Corporate PDF

08

MSN

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RLD : No

TE Code :

OBETICHOLIC ACID

Brand Name : OBETICHOLIC ACID

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2023-05-30

Application Number : 215017

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product Web Link

Digital Content

Corporate PDF

09

OPTIMUS PHARMA PRIVATE LTD

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OPTIMUS PHARMA PRIVATE LTD

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RLD :

TE Code :

OBETICHOLIC ACID

Brand Name : OBETICHOLIC ACID

Dosage Form : TABLET; ORAL

Dosage Strength : 10mg

Approval Date :

Application Number : 214935

RX/OTC/DISCN :

RLD :

TE Code :

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