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Dexbrompheniramine Maleate
FDA Orange Book

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

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SPI Pharma has been solving formulation challenges using superior functional materials.

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Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.

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Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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FAMAR CDMO- From early development to commercial manufacturing.

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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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Dexbrompheniramine Maleate

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

10 API Suppliers, 5 USDMF, 1 EU WC, 1 NDC API, 6 Listed Suppliers, $ API Reference Price

10 API Suppliers
5 USDMF
1 EU WC
1 NDC API
6 Listed Suppliers
$ API Reference Price

FINISHED DOSAGE FORMULATIONS

10 FDF Dossiers, 10 FDA Orange Book

10 FDF Dossiers
10 FDA Orange Book

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 3 Evonik, 7 Rochem International Inc, 18 SPI Pharma, 2 Seqens, 9 DKSH, 1 Pharm-RX Chemical, 8 Faran Shimi Pharmaceutical, 4 Boai NKY Pharmaceuticals Ltd, 8 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 10 Actylis, 1 Aeon Procare, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 29 BASF, 1 Bioplus Life Sciences, 1 Clariant, 11 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 11 Gangwal Chemicals, 9 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 31 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 19 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 10 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 30 Roquette, 15 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 3 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus, 2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

92 Fillers, Diluents & Binders, 59 Coating Systems & Additives, 36 Thickeners and Stabilizers, 35 Solubilizers, 33 Direct Compression, 33 Controlled & Modified Release, 32 Disintegrants & Superdisintegrants, 31 Taste Masking, 27 Granulation, 26 Parenteral, 25 Film Formers & Plasticizers, 21 Topical, 19 Chewable & Orodispersible Aids, 19 Lubricants & Glidants, 17 Co-Processed Excipients, 9 Emulsifying Agents, 9 Empty Capsules, 8 Rheology Modifiers, 7 Surfactant & Foaming Agents, 6 API Stability Enhancers, 4 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

92 Fillers, Diluents & Binders
59 Coating Systems & Additives
36 Thickeners and Stabilizers
35 Solubilizers
33 Direct Compression
33 Controlled & Modified Release
32 Disintegrants & Superdisintegrants
31 Taste Masking
27 Granulation
26 Parenteral
25 Film Formers & Plasticizers
21 Topical
19 Chewable & Orodispersible Aids
19 Lubricants & Glidants
17 Co-Processed Excipients
9 Emulsifying Agents
9 Empty Capsules
8 Rheology Modifiers
7 Surfactant & Foaming Agents
6 API Stability Enhancers
4 Coloring Agents
4 Vegetarian Capsules
1 Soft Gelatin

REF. STANDARDS & IMPURITIES

1 USP, 1 Others

1 USP
1 Others

$ API Ref.Price (USD/KG) : 1,236 Xls

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01 1AVANTHI INC

02 1COPLEY PHARM

03 1PIONEER PHARMS

04 1SANDOZ

05 3SCHERING

06 3SCHERING PLOUGH

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10 All

01 1SYRUP;ORAL

02 7TABLET, EXTENDED RELEASE;ORAL

03 2TABLET;ORAL

filter Regulatory Info Reset all filters

10 All

01 10DISCN

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10 All

01 1BROMPHERIL

02 1DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE

03 1DISOBROM

04 2DISOMER

05 2DISOPHROL

06 1DRIXORAL

07 1DRIXORAL PLUS

08 1RESPORAL

filter RLD Reset all filters

10 All

01 9No

02 1Yes

List of Suppliers

Product Main Page

01

AVANTHI INC

BioAsia

Not Confirmed

AVANTHI INC

BioAsia

Not Confirmed

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Digital Content

RLD : No

TE Code :

DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

Brand Name : DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 6MG;120MG

Approval Date : 2013-02-27

Application Number : 78648

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

SCHERING

PharmScience R&D

Not Confirmed

SCHERING

PharmScience R&D

Not Confirmed

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Digital Content

RLD : No

TE Code :

DEXBROMPHENIRAMINE MALEATE

Brand Name : DISOMER

Dosage Form : TABLET;ORAL

Dosage Strength : 2MG

Approval Date : 1982-01-01

Application Number : 11814

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

SCHERING

PharmScience R&D

Not Confirmed

SCHERING

PharmScience R&D

Not Confirmed

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Digital Content

RLD : No

TE Code :

DEXBROMPHENIRAMINE MALEATE

Brand Name : DISOMER

Dosage Form : SYRUP;ORAL

Dosage Strength : 2MG/5ML

Approval Date : 1982-01-01

Application Number : 11814

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

SCHERING

PharmScience R&D

Not Confirmed

SCHERING

PharmScience R&D

Not Confirmed

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Digital Content

RLD : No

TE Code :

DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

Brand Name : DISOPHROL

Dosage Form : TABLET;ORAL

Dosage Strength : 2MG;60MG

Approval Date : 1982-01-01

Application Number : 12394

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

COPLEY PHARM

BioAsia

Not Confirmed

COPLEY PHARM

BioAsia

Not Confirmed

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Digital Content

RLD : No

TE Code :

DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

Brand Name : BROMPHERIL

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 6MG;120MG

Approval Date : 1987-01-22

Application Number : 89116

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

SCHERING PLOUGH

PharmScience R&D

Not Confirmed

SCHERING PLOUGH

PharmScience R&D

Not Confirmed

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RLD : Yes

TE Code :

DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

Brand Name : DRIXORAL

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 6MG;120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-09-13

Application Number : 13483

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

SCHERING PLOUGH

PharmScience R&D

Not Confirmed

SCHERING PLOUGH

PharmScience R&D

Not Confirmed

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Digital Content

RLD : No

TE Code :

DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

Brand Name : DISOPHROL

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 6MG;120MG

Approval Date : 1982-09-13

Application Number : 13483

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

SCHERING PLOUGH

PharmScience R&D

Not Confirmed

SCHERING PLOUGH

PharmScience R&D

Not Confirmed

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Digital Content

RLD : No

TE Code :

ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

Brand Name : DRIXORAL PLUS

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 500MG;3MG;60MG

Approval Date : 1987-05-22

Application Number : 19453

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

PIONEER PHARMS

BioAsia

Not Confirmed

PIONEER PHARMS

BioAsia

Not Confirmed

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Digital Content

RLD : No

TE Code :

DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

Brand Name : RESPORAL

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 6MG;120MG

Approval Date : 1988-06-16

Application Number : 89139

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

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Digital Content

Corporate PDF

10

SANDOZ

PharmScience R&D

Not Confirmed

SANDOZ

PharmScience R&D

Not Confirmed

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Digital Content

RLD : No

TE Code :

DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

Brand Name : DISOBROM

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 6MG;120MG

Approval Date : 1991-09-30

Application Number : 70770

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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