OCALIVA | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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OCALIVA
FDA Orange Book

ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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

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dmfs-not-supported-m-2025-06-16

AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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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-2025-06-09

OCALIVA

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

32 API Suppliers, 11 USDMF, 5 EU WC, 9 NDC API, 24 Listed Suppliers, $ API Reference Price

32 API Suppliers
11 USDMF
5 EU WC
9 NDC API
24 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

35 Drugs in Development

35 Drugs in Development

INTERMEDIATES

17 Intermediate Suppliers

17 Intermediate 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, 1 Faran Shimi Pharmaceutical, 3 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 Silverline Chemicals, 3 Vasa Pharmachem

1 SPI Pharma
2 DKSH
1 Faran Shimi Pharmaceutical
3 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 Silverline Chemicals
3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

20 Coating Systems & Additives, 19 Fillers, Diluents & Binders, 14 Disintegrants & Superdisintegrants, 13 Lubricants & Glidants, 10 Co-Processed Excipients, 9 Thickeners and Stabilizers, 8 Direct Compression, 8 Controlled & Modified Release, 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

20 Coating Systems & Additives
19 Fillers, Diluents & Binders
14 Disintegrants & Superdisintegrants
13 Lubricants & Glidants
10 Co-Processed Excipients
9 Thickeners and Stabilizers
8 Direct Compression
8 Controlled & Modified Release
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

72 News #PharmaBuzz

72 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 4 Regulatory FDF Prices

1 US Medicaid Prescriptions
4 Regulatory FDF 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) : 9,745 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

List of Suppliers

Product Main Page

01

APOTEX

DIA 2025

Not Confirmed

APOTEX

DIA 2025

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

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

Product Web Link

Digital Content

Corporate PDF

02

APOTEX

DIA 2025

Not Confirmed

APOTEX

DIA 2025

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

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

Digital Content

Corporate PDF

03

INTERCEPT PHARMS INC

DIA 2025

Not Confirmed

INTERCEPT PHARMS INC

DIA 2025

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

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

Product Web Link

Digital Content

04

INTERCEPT PHARMS INC

DIA 2025

Not Confirmed

INTERCEPT PHARMS INC

DIA 2025

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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Post an Enquiry

Digital Content

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

Product Web Link

Digital Content

05

LUPIN LTD

DIA 2025

Not Confirmed

LUPIN LTD

DIA 2025

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

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 :

Product Web Link

Digital Content

Corporate PDF

06

LUPIN LTD

DIA 2025

Not Confirmed

LUPIN LTD

DIA 2025

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

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

DIA 2025

Not Confirmed

MSN

DIA 2025

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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Post an Enquiry

Digital Content

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 :

Product Web Link

Digital Content

Corporate PDF

08

MSN

DIA 2025

Not Confirmed

MSN

DIA 2025

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

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

DIA 2025

Not Confirmed

OPTIMUS PHARMA PRIVATE LTD

DIA 2025

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

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 :

Product Web Link

Digital Content

Corporate PDF

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