Dexchloropheniramine Maleate | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Dexchloropheniramine Maleate
South Africa

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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Dexchloropheniramine Maleate

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ACTIVE PHARMA INGREDIENTS

11 API Suppliers, 6 USDMF, 1 CEP/COS, 3 EU WC, 3 KDMF, 3 NDC API, 7 Listed Suppliers

11 API Suppliers
6 USDMF
1 CEP/COS
3 EU WC
3 KDMF
3 NDC API
7 Listed Suppliers

FINISHED DOSAGE FORMULATIONS

22 FDF Dossiers, 14 FDA Orange Book, 2 Europe, 3 South Africa, 3 Listed Dossiers

22 FDF Dossiers
14 FDA Orange Book
2 Europe
3 South Africa
3 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SUSPENSION, EXTENDED RELEASE;ORAL - EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SUSPENSION, EXTENDED RELEASE;ORAL - EQ 2.8MG BASE/5ML;EQ 14.7MG BASE/5ML, SYRUP;ORAL - 2MG/5ML

SUSPENSION, EXTENDED RELEASE;ORAL - EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SUSPENSION, EXTENDED RELEASE;ORAL - EQ 2.8MG BASE/5ML;EQ 14.7MG BASE/5ML
SYRUP;ORAL - 2MG/5ML

RELATED EXCIPIENT COMPANIES

4 Rochem International Inc, 3 SPI Pharma, 4 DKSH, 2 Pharm-RX Chemical, 3 Faran Shimi Pharmaceutical, 7 Boai NKY Pharmaceuticals Ltd, 10 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 6 Actylis, 1 Alcedo Pharmachem, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 7 BASF, 1 Bioplus Life Sciences, 4 DFE Pharma, 1 Finar, 7 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 19 Kerry, 10 Microlex e.U, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 4 Pluviaendo, 2 Prachin Chemical, 18 Roquette, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 9 Sigachi Industries, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 2 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

49 Fillers, Diluents & Binders, 26 Direct Compression, 20 Thickeners and Stabilizers, 16 Disintegrants & Superdisintegrants, 15 Co-Processed Excipients, 14 Film Formers & Plasticizers, 13 Granulation, 12 Taste Masking, 12 Lubricants & Glidants, 10 Coating Systems & Additives, 8 Parenteral, 7 Controlled & Modified Release, 7 Chewable & Orodispersible Aids, 6 Solubilizers, 6 Topical, 4 Emulsifying Agents, 3 API Stability Enhancers, 3 Rheology Modifiers, 1 Soft Gelatin

49 Fillers, Diluents & Binders
26 Direct Compression
20 Thickeners and Stabilizers
16 Disintegrants & Superdisintegrants
15 Co-Processed Excipients
14 Film Formers & Plasticizers
13 Granulation
12 Taste Masking
12 Lubricants & Glidants
10 Coating Systems & Additives
8 Parenteral
7 Controlled & Modified Release
7 Chewable & Orodispersible Aids
6 Solubilizers
6 Topical
4 Emulsifying Agents
3 API Stability Enhancers
3 Rheology Modifiers
1 Soft Gelatin

DIGITAL CONTENT

4 NEWS #PharmaBuzz

4 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 Finished Drug Prices

2 Finished Drug Prices

MARKET PLACE

7 APIs, 1 FDF Dossiers

7 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

2 US Patents

2 US Patents

REF. STANDARDS & IMPURITIES

1 EDQM, 1 USP, 1 Others

1 EDQM
1 USP
1 Others

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01 2Pharmacare Limited, Woodmead

02 1Schering-Plough (Pty) Ltd - (Site1)

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01 3Dexchlorpheniramine Maleate

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01 1INJ

02 1SYR

03 1TAB

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01 1Betadexamine

02 1Betadexamine Tablets

03 1PegIntron 150 Microgram

List of Suppliers

Product Main Page

01

Pharmacare Limited, Woodmead

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Dexchlorpheniramine Maleate

Brand Name : Betadexamine Tablets

Dosage Form : TAB

Dosage Strength : 2mg

Packaging : 30X1mcg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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02

Pharmacare Limited, Woodmead

Pharma, Lab & Chemical Expo

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Dexchlorpheniramine Maleate

Brand Name : Betadexamine

Dosage Form : SYR

Dosage Strength : 2mg/5 ml

Packaging : 100X1mg/5 ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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03

Schering-Plough (Pty) Ltd - (Site1)

Pharma, Lab & Chemical Expo

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Schering-Plough (Pty) Ltd - (Site1)

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Dexchlorpheniramine Maleate

Brand Name : PegIntron 150 Microgram

Dosage Form : INJ

Dosage Strength : 2mg

Packaging : 0.7X1mcg/0.7ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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