Ceftibuten Dihydrate | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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Ceftibuten Dihydrate
FDA Orange Book

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.

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xyz-pharma-m-2024-10-07

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With Fermion, start the journey of your innovative API.

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Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.

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xyz-pharma-m-2024-10-07

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Ceftibuten Dihydrate

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

2 API Suppliers, 1 EU WC, 1 Listed Suppliers, $ API Reference Price

2 API Suppliers
1 EU WC
1 Listed Suppliers
$ API Reference Price

INTERMEDIATES

2 Intermediates Suppliers

2 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

7 FDF Dossiers, 3 FDA Orange Book, 2 Europe, 2 Listed Dossiers

7 FDF Dossiers
3 FDA Orange Book
2 Europe
2 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

FOR SUSPENSION;ORAL - EQ 180MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - EQ 90MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

FOR SUSPENSION;ORAL - EQ 180MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
FOR SUSPENSION;ORAL - EQ 90MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 1 SPI Pharma, 9 DKSH, 1 Pharm-RX Chemical, 2 Faran Shimi Pharmaceutical, 7 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 4 Actylis, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 6 BASF, 3 DFE Pharma, 1 Finar, 8 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 3 Kerry, 3 Lonza Capsugel, 7 Microlex e.U, 1 Nanjing Bold Chemical, 2 Pharmatrans-Sanaq, 2 Pluviaendo, 3 Prachin Chemical, 1 Qualicaps, 11 Roquette, 6 Seppic, 2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 9 Sigachi Industries, 3 Vasa Pharmachem

1 Rochem International Inc
1 SPI Pharma
9 DKSH
1 Pharm-RX Chemical
2 Faran Shimi Pharmaceutical
7 Gangwal Healthcare
2 Nanjing Well Pharmaceutical
1 Pfanstiehl
4 ACG Worldwide
4 Actylis
4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
6 BASF
3 DFE Pharma
1 Finar
8 Gangwal Chemicals
1 Ideal Cures Pvt Ltd
1 Ingredion Pharma Solutions
3 Kerry
3 Lonza Capsugel
7 Microlex e.U
1 Nanjing Bold Chemical
2 Pharmatrans-Sanaq
2 Pluviaendo
3 Prachin Chemical
1 Qualicaps
11 Roquette
6 Seppic
2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
9 Sigachi Industries
3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

24 Fillers, Diluents & Binders, 23 Thickeners and Stabilizers, 16 Direct Compression, 14 Lubricants & Glidants, 14 Disintegrants & Superdisintegrants, 11 Solubilizers, 10 Coating Systems & Additives, 9 Granulation, 9 Co-Processed Excipients, 8 Empty Capsules, 8 Topical, 7 Parenteral, 6 Taste Masking, 6 Emulsifying Agents, 5 Controlled & Modified Release, 5 Film Formers & Plasticizers, 4 Rheology Modifiers, 3 API Stability Enhancers, 3 Surfactant & Foaming Agents, 2 Coloring Agents, 2 Chewable & Orodispersible Aids

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

GLOBAL SALES INFORMATION

1 Finished Drug Prices

1 Finished Drug Prices

MARKET PLACE

2 APIs

2 APIs

$ API Ref.Price (USD/KG) : 1,570 Xls

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01 3CEDAX

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02 2Yes

List of Suppliers

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SI PHARMS

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RLD : No

TE Code :

CEFTIBUTEN DIHYDRATE

Brand Name : CEDAX

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 400MG BASE

Approval Date : 1995-12-20

Application Number : 50685

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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02

SI PHARMS

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Pharma, Lab & Chemical Expo

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SI PHARMS

Country

Pharma, Lab & Chemical Expo

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 : Yes

TE Code :

CEFTIBUTEN DIHYDRATE

Brand Name : CEDAX

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : EQ 90MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1995-12-20

Application Number : 50686

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

03

SI PHARMS

Country

Pharma, Lab & Chemical Expo

Not Confirmed

SI PHARMS

Country

Pharma, Lab & Chemical Expo

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

Country

Virtual Booth

Digital Content

RLD : Yes

TE Code :

CEFTIBUTEN DIHYDRATE

Brand Name : CEDAX

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : EQ 180MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1995-12-20

Application Number : 50686

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

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