Memantine Hydrochloride | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Memantine Hydrochloride
South Africa

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Memantine Hydrochloride

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

102 API Suppliers, 33 USDMF, 2 CEP/COS, 11 JDMF, 14 EU WC, 32 KDMF, 29 NDC API, 44 Listed Suppliers, $ API Reference Price

102 API Suppliers
33 USDMF
2 CEP/COS
11 JDMF
14 EU WC
32 KDMF
29 NDC API
44 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

27 Drugs in Development

27 Drugs in Development

INTERMEDIATES

14 Intermediate Suppliers

14 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

641 FDF Dossiers, 129 FDA Orange Book, 402 Europe, 12 Canada, 14 Australia, 8 South Africa, 76 Listed Dossiers

641 FDF Dossiers
129 FDA Orange Book
402 Europe
12 Canada
14 Australia
8 South Africa
76 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG, TABLET;ORAL - 5MG, CAPSULE, EXTENDED RELEASE;ORAL - 14MG, CAPSULE, EXTENDED RELEASE;ORAL - 21MG, CAPSULE, EXTENDED RELEASE;ORAL - 28MG, CAPSULE, EXTENDED RELEASE;ORAL - 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 10MG
TABLET;ORAL - 5MG
CAPSULE, EXTENDED RELEASE;ORAL - 14MG
CAPSULE, EXTENDED RELEASE;ORAL - 21MG
CAPSULE, EXTENDED RELEASE;ORAL - 28MG
CAPSULE, EXTENDED RELEASE;ORAL - 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Minakem, 2 Rochem International Inc, 8 SPI Pharma, 1 Pharm-RX Chemical, 5 Boai NKY Pharmaceuticals Ltd, 8 Gangwal Healthcare, 8 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 1 Pfanstiehl, 4 Kirsch Pharma, 1 Panvo Organics, 4 ACG Worldwide, 8 Actylis, 1 Aeon Procare, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 1 Avesta Pharma, 26 BASF, 1 Bioplus Life Sciences, 1 CD Formulation, 2 Clariant, 11 Corel Pharma Chem, 7 DFE Pharma, 1 Esteem Industries, 2 Finar, 9 Gangwal Chemicals, 5 Ideal Cures, 4 Ingredion Pharma Solutions, 25 Kerry, 3 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 12 Microlex e.U, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 8 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 27 Roquette, 8 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 Silverline Chemicals, 3 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

66 Fillers, Diluents & Binders, 52 Coating Systems & Additives, 31 Granulation, 31 Direct Compression, 31 Controlled & Modified Release, 30 Disintegrants & Superdisintegrants, 25 Film Formers & Plasticizers, 25 Thickeners and Stabilizers, 24 Lubricants & Glidants, 21 Topical, 20 Taste Masking, 19 Solubilizers, 18 Parenteral, 13 Co-Processed Excipients, 10 Chewable & Orodispersible Aids, 9 Empty Capsules, 6 API Stability Enhancers, 6 Emulsifying Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 4 Rheology Modifiers, 2 Coloring Agents, 1 Soft Gelatin

66 Fillers, Diluents & Binders
52 Coating Systems & Additives
31 Granulation
31 Direct Compression
31 Controlled & Modified Release
30 Disintegrants & Superdisintegrants
25 Film Formers & Plasticizers
25 Thickeners and Stabilizers
24 Lubricants & Glidants
21 Topical
20 Taste Masking
19 Solubilizers
18 Parenteral
13 Co-Processed Excipients
10 Chewable & Orodispersible Aids
9 Empty Capsules
6 API Stability Enhancers
6 Emulsifying Agents
4 Vegetarian Capsules
4 Surfactant & Foaming Agents
4 Rheology Modifiers
2 Coloring Agents
1 Soft Gelatin

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 86 News #PharmaBuzz

1 Data Compilation #PharmaFlow
86 News #PharmaBuzz

GLOBAL SALES INFORMATION

34 US Medicaid Prescriptions, 46 Regulatory FDF Prices, 12 Annual Reports

34 US Medicaid Prescriptions
46 Regulatory FDF Prices
12 Annual Reports

MARKET PLACE

16 APIs, 5 FDF Dossiers

16 APIs
5 FDF Dossiers

PATENTS & EXCLUSIVITIES

36 US Patents, 2 US Exclusivities, 1 Health Canada Patents

36 US Patents
2 US Exclusivities
1 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 USP, 23 Others

1 USP
23 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 476 Xls

Filters

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8 All

01 1Adcock Ingram Limited

02 2H. Lundbeck (Pty) Ltd

03 1Macleods Pharmaceuticals SA (Pty) Ltd

04 2Unichem SA (Pty) Ltd

05 1Unicorn Pharmaceuticals (Pty) Ltd

06 1Zydus Healthcare SA (Pty) Ltd

filter Active Ingredients Reset all filters

8 All

01 1Memantine

02 3Memantine Hydrochloride

03 3Memantine hydrochloride

04 1memantine

filter Dosage Form Reset all filters

8 All

01 1DRP

02 4FCT

03 2TAB

04 1TABS

filter Brand Name Reset all filters

8 All

01 1Ebitine

02 1Ebixa 10 mg

03 1Ebixa 10mg/g Drops

04 1Emorix

05 1Memantine Unichem 10

06 1Meminist 10

07 1Memor 10 mg

08 1Noalzh 10

Memantine Hydrochloride

List of Suppliers

Product Main Page

01

Adcock Ingram Limited

ASPEN

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Adcock Ingram Limited

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Memantine Hydrochloride

Brand Name : Ebitine

Dosage Form : TAB

Dosage Strength : 10mg

Packaging : 60X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

H. Lundbeck (Pty) Ltd

ASPEN

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H. Lundbeck (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Memantine hydrochloride

Brand Name : Ebixa 10 mg

Dosage Form : TAB

Dosage Strength : 10mg

Packaging : 56X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Digital Content

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03

H. Lundbeck (Pty) Ltd

ASPEN

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H. Lundbeck (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Memantine hydrochloride

Brand Name : Ebixa 10mg/g Drops

Dosage Form : DRP

Dosage Strength : 10mg/g

Packaging : 50X1mg/g

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Corporate PDF

04

Macleods Pharmaceuticals SA (Pty) Ltd

ASPEN

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Macleods Pharmaceuticals SA (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Noalzh 10

Dosage Form : FCT

Dosage Strength : 10mg

Packaging : 56X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Product Web Link

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Corporate PDF

05

Unichem SA (Pty) Ltd

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Unichem SA (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Memantine Hydrochloride

Brand Name : Memantine Unichem 10

Dosage Form : FCT

Dosage Strength : 10mg

Packaging : 60X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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06

Unichem SA (Pty) Ltd

ASPEN

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Unichem SA (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Memantine Hydrochloride

Brand Name : Meminist 10

Dosage Form : FCT

Dosage Strength : 10mg

Packaging : 60X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

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Corporate PDF

07

Unicorn Pharmaceuticals (Pty) Ltd

ASPEN

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Unicorn Pharmaceuticals (Pty) Ltd

ASPEN

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Emorix

Dosage Form : TABS

Dosage Strength : 10mg

Packaging : 56X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

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08

Zydus Healthcare SA (Pty) Ltd

ASPEN

Not Confirmed

Zydus Healthcare SA (Pty) Ltd

ASPEN

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Memantine hydrochloride

Brand Name : Memor 10 mg

Dosage Form : FCT

Dosage Strength : 10mg

Packaging : 60X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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