Galantamine Hydrobromide | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Galantamine Hydrobromide
South Africa

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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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Galantamine Hydrobromide

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

30 API Suppliers, 15 USDMF, 8 CEP/COS, 4 JDMF, 2 EU WC, 5 KDMF, 7 NDC API, 14 Listed Suppliers, $ API Reference Price

30 API Suppliers
15 USDMF
8 CEP/COS
4 JDMF
2 EU WC
5 KDMF
7 NDC API
14 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

246 FDF Dossiers, 71 FDA Orange Book, 110 Europe, 15 Canada, 24 Australia, 9 South Africa, 17 Listed Dossiers

246 FDF Dossiers
71 FDA Orange Book
110 Europe
15 Canada
24 Australia
9 South Africa
17 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE, EXTENDED RELEASE;ORAL - EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE, EXTENDED RELEASE;ORAL - EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE, EXTENDED RELEASE;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 2 Rochem International Inc, 18 SPI Pharma, 2 Seqens, 9 DKSH, 6 Faran Shimi Pharmaceutical, 5 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 6 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 Pramukh Pharmachem, 4 ACG Worldwide, 7 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 30 BASF, 1 Clariant, 11 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 11 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 37 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 15 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 3 Novo Excipients, 5 Pharmatrans-Sanaq, 6 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 19 Roquette, 14 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 3 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 2 Vertellus

EXCIPIENTS BY APPLICATIONS

87 Fillers, Diluents & Binders, 53 Coating Systems & Additives, 37 Direct Compression, 36 Disintegrants & Superdisintegrants, 32 Thickeners and Stabilizers, 32 Controlled & Modified Release, 30 Granulation, 26 Solubilizers, 24 Taste Masking, 21 Lubricants & Glidants, 20 Chewable & Orodispersible Aids, 18 Film Formers & Plasticizers, 17 Parenteral, 16 Co-Processed Excipients, 15 Topical, 9 Empty Capsules, 8 Emulsifying Agents, 5 Surfactant & Foaming Agents, 5 API Stability Enhancers, 5 Coloring Agents, 4 Rheology Modifiers, 4 Vegetarian Capsules

87 Fillers, Diluents & Binders
53 Coating Systems & Additives
37 Direct Compression
36 Disintegrants & Superdisintegrants
32 Thickeners and Stabilizers
32 Controlled & Modified Release
30 Granulation
26 Solubilizers
24 Taste Masking
21 Lubricants & Glidants
20 Chewable & Orodispersible Aids
18 Film Formers & Plasticizers
17 Parenteral
16 Co-Processed Excipients
15 Topical
9 Empty Capsules
8 Emulsifying Agents
5 Surfactant & Foaming Agents
5 API Stability Enhancers
5 Coloring Agents
4 Rheology Modifiers
4 Vegetarian Capsules

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 8 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
8 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 96 Finished Drug Prices, 6 Annual Reports

3 US Medicaid Prescriptions
96 Finished Drug Prices
6 Annual Reports

MARKET PLACE

6 APIs

6 APIs

PATENTS & EXCLUSIVITIES

20 Health Canada Patents

20 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 3 USP, 3 Others

4 EDQM
3 USP
3 Others

$ API Ref.Price (USD/KG) : 5,234 Xls

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01 3Actavis Pharma (Pty) Ltd

02 6Janssen Pharmaceutica (Pty) Ltd

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01 9Galantamine

filter Dosage Form Reset all filters

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01 6CAP

02 3TAB

filter Brand Name Reset all filters

9 All

01 1REMCEPT XL 16 mg

02 1REMCEPT XL 24 mg

03 1REMCEPT XL 8 mg

04 1Reminyl 12Mg

05 1Reminyl 4Mg

06 1Reminyl 8Mg

07 1Reminyl Cr 16Mg

08 1Reminyl Cr 24Mg

09 1Reminyl Cr 8Mg

Capital Farma Galantamine Hydrobromide

List of Suppliers

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01

Actavis Pharma (Pty) Ltd

PharmScience R&D

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Actavis Pharma (Pty) Ltd

PharmScience R&D

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Regulatory Info : Generic

Registration Country : South Africa

Galantamine

Brand Name : REMCEPT XL 8 mg

Dosage Form : CAP

Dosage Strength : 8mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

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02

Actavis Pharma (Pty) Ltd

PharmScience R&D

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Actavis Pharma (Pty) Ltd

PharmScience R&D

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Regulatory Info : Generic

Registration Country : South Africa

Galantamine

Brand Name : REMCEPT XL 16 mg

Dosage Form : CAP

Dosage Strength : 16mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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03

Actavis Pharma (Pty) Ltd

PharmScience R&D

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Actavis Pharma (Pty) Ltd

PharmScience R&D

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Regulatory Info : Generic

Registration Country : South Africa

Galantamine

Brand Name : REMCEPT XL 24 mg

Dosage Form : CAP

Dosage Strength : 24mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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04

Janssen Pharmaceutica (Pty) Ltd

PharmScience R&D

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Janssen Pharmaceutica (Pty) Ltd

PharmScience R&D

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Regulatory Info : Originator

Registration Country : South Africa

Galantamine

Brand Name : Reminyl Cr 8Mg

Dosage Form : CAP

Dosage Strength : 8mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

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05

Janssen Pharmaceutica (Pty) Ltd

PharmScience R&D

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Janssen Pharmaceutica (Pty) Ltd

PharmScience R&D

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Regulatory Info : Originator

Registration Country : South Africa

Galantamine

Brand Name : Reminyl Cr 16Mg

Dosage Form : CAP

Dosage Strength : 16mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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06

Janssen Pharmaceutica (Pty) Ltd

PharmScience R&D

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Janssen Pharmaceutica (Pty) Ltd

PharmScience R&D

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Galantamine

Brand Name : Reminyl Cr 24Mg

Dosage Form : CAP

Dosage Strength : 24mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Janssen Pharmaceutica (Pty) Ltd

PharmScience R&D

Not Confirmed

Janssen Pharmaceutica (Pty) Ltd

PharmScience R&D

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Regulatory Info : Originator

Registration Country : South Africa

Galantamine

Brand Name : Reminyl 4Mg

Dosage Form : TAB

Dosage Strength : 4mg

Packaging : 56X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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08

Janssen Pharmaceutica (Pty) Ltd

PharmScience R&D

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Janssen Pharmaceutica (Pty) Ltd

PharmScience R&D

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Galantamine

Brand Name : Reminyl 8Mg

Dosage Form : TAB

Dosage Strength : 8mg

Packaging : 56X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Janssen Pharmaceutica (Pty) Ltd

PharmScience R&D

Not Confirmed

Janssen Pharmaceutica (Pty) Ltd

PharmScience R&D

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Regulatory Info : Originator

Registration Country : South Africa

Galantamine

Brand Name : Reminyl 12Mg

Dosage Form : TAB

Dosage Strength : 12mg

Packaging : 56X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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