Xifaxan, Rifacol, Fatroximin, Rifaximin | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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Xifaxan, Rifacol, Fatroximin, Rifaximin
FDA Orange Book

EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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

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pharmacompass-1-m-2026-04-20

European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.

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Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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pharmacompass-2-m-2026-04-20

Xifaxan, Rifacol, Fatroximin, Rifaximin

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

59 API Suppliers, 26 USDMF, 12 CEP/COS, 3 JDMF, 7 EU WC, 9 KDMF, 17 NDC API, 32 Listed Suppliers

59 API Suppliers
26 USDMF
12 CEP/COS
3 JDMF
7 EU WC
9 KDMF
17 NDC API
32 Listed Suppliers

DEVELOPMENTS

52 Drugs in Development

52 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

58 FDF Dossiers, 11 FDA Orange Book, 28 Europe, 1 Canada, 1 Australia, 1 South Africa, 16 Listed Dossiers

58 FDF Dossiers
11 FDA Orange Book
28 Europe
1 Canada
1 Australia
1 South Africa
16 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 200MG, TABLET;ORAL - 550MG

TABLET;ORAL - 200MG
TABLET;ORAL - 550MG

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 2 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Kirsch Pharma, 1 ACG Worldwide, 1 Aeon Procare, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 BASF, 10 Corel Pharma Chem, 3 DFE Pharma, 1 Finar, 7 Gangwal Chemicals, 5 Ideal Cures, 1 Ingredion Pharma Solutions, 12 Kerry, 2 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 3 Microlex e.U, 1 Nitika Pharmaceutical Specialities, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 11 Roquette, 6 Seppic, 2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 2 Silverline Chemicals, 2 The Dow Chemical Company, 1 Valens Pharmachem, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

42 Coating Systems & Additives, 18 Controlled & Modified Release, 18 Fillers, Diluents & Binders, 14 Disintegrants & Superdisintegrants, 12 Thickeners and Stabilizers, 9 Direct Compression, 8 Film Formers & Plasticizers, 8 Granulation, 7 Co-Processed Excipients, 5 Lubricants & Glidants, 5 Empty Capsules, 5 API Stability Enhancers, 4 Chewable & Orodispersible Aids, 4 Vegetarian Capsules, 4 Taste Masking, 4 Topical, 3 Parenteral, 3 Solubilizers, 3 Emulsifying Agents, 2 Rheology Modifiers, 2 Coloring Agents

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

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 82 News #PharmaBuzz

1 Data Compilation #PharmaFlow
82 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 4 Regulatory FDF Prices, 3 Annual Reports

1 US Medicaid Prescriptions
4 Regulatory FDF Prices
3 Annual Reports

MARKET PLACE

36 APIs, 8 FDF Dossiers

36 APIs
8 FDF Dossiers

PATENTS & EXCLUSIVITIES

33 US Patents, 3 Health Canada Patents

33 US Patents
3 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 2 Others

2 EDQM
1 USP
2 Others

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11 All

01 1ACTAVIS LABS FL INC

02 1ALKEM LABORATORIES LIMITED

03 1CIPLA LTD

04 1MYLAN PHARMACEUTICALS INC

05 1NORWICH

06 1NORWICH PHARMACEUTICALS INC

07 3SALIX PHARMS

08 1SANDOZ INC

09 1ZYDUS PHARMS USA INC

filter Dosage Reset all filters

11 All

01 4TABLET

02 7TABLET;ORAL

filter Regulatory Info Reset all filters

11 All

01 3RX

02 8Blank

filter Brand Name Reset all filters

11 All

01 8RIFAXIMIN

02 3XIFAXAN

filter RLD Reset all filters

11 All

01 1No

02 2Yes

03 8Blank

List of Suppliers

Product Main Page

01

ACTAVIS LABS FL INC

RDD

Not Confirmed

ACTAVIS LABS FL INC

RDD

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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RLD : No

TE Code : AB

Brand Name : RIFAXIMIN

Dosage Form : TABLET;ORAL

Dosage Strength : 550MG

Approval Date : 2026-03-19

Application Number : 208959

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

NORWICH

RDD

Not Confirmed

NORWICH

RDD

Not Confirmed

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RLD :

TE Code :

Brand Name : RIFAXIMIN

Dosage Form : TABLET;ORAL

Dosage Strength : 200MG

Approval Date :

Application Number : 214370

RX/OTC/DISCN :

RLD :

TE Code :

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03

CIPLA LTD

RDD

Not Confirmed

CIPLA LTD

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RLD :

TE Code :

Brand Name : RIFAXIMIN

Dosage Form : TABLET

Dosage Strength : 200MG

Approval Date :

Application Number : 219570

RX/OTC/DISCN :

RLD :

TE Code :

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04

NORWICH PHARMACEUTICALS INC

RDD

Not Confirmed

NORWICH PHARMACEUTICALS INC

RDD

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RLD :

TE Code :

Brand Name : RIFAXIMIN

Dosage Form : TABLET;ORAL

Dosage Strength : 550MG

Approval Date :

Application Number : 214369

RX/OTC/DISCN :

RLD :

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

SALIX PHARMS

RDD

Not Confirmed

SALIX PHARMS

RDD

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RLD : Yes

TE Code :

Brand Name : XIFAXAN

Dosage Form : TABLET;ORAL

Dosage Strength : 200MG

Approval Date : 2004-05-25

Application Number : 21361

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

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Corporate PDF

06

SALIX PHARMS

RDD

Not Confirmed

SALIX PHARMS

RDD

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RLD : Yes

TE Code : AB

Brand Name : XIFAXAN

Dosage Form : TABLET;ORAL

Dosage Strength : 550MG

Approval Date : 2010-03-24

Application Number : 21361

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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07

SALIX PHARMS

RDD

Not Confirmed

SALIX PHARMS

RDD

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RLD :

TE Code :

Brand Name : XIFAXAN

Dosage Form : TABLET;ORAL

Dosage Strength : 550MG

Approval Date :

Application Number : 22554

RX/OTC/DISCN :

RLD :

TE Code :

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08

SANDOZ INC

RDD

Not Confirmed

SANDOZ INC

RDD

Not Confirmed

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RLD :

TE Code :

Brand Name : RIFAXIMIN

Dosage Form : TABLET;ORAL

Dosage Strength : 550MG

Approval Date :

Application Number : 213713

RX/OTC/DISCN :

RLD :

TE Code :

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09

MYLAN PHARMACEUTICALS INC

RDD

Not Confirmed

MYLAN PHARMACEUTICALS INC

RDD

Not Confirmed

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RLD :

TE Code :

Brand Name : RIFAXIMIN

Dosage Form : TABLET

Dosage Strength : 550MG

Approval Date :

Application Number : 219687

RX/OTC/DISCN :

RLD :

TE Code :

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10

ZYDUS PHARMS USA INC

RDD

Not Confirmed

ZYDUS PHARMS USA INC

RDD

Not Confirmed

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RLD :

TE Code :

Brand Name : RIFAXIMIN

Dosage Form : TABLET

Dosage Strength : 200MG

Approval Date :

Application Number : 218650

RX/OTC/DISCN :

RLD :

TE Code :

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Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.