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

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Methylphenidate Hydrochloride
South Africa

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Methylphenidate Hydrochloride

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

36 API Suppliers, 20 USDMF, 16 CEP/COS, 1 JDMF, 6 EU WC, 8 KDMF, 22 NDC API, 17 Listed Suppliers, $ API Reference Price

36 API Suppliers
20 USDMF
16 CEP/COS
1 JDMF
6 EU WC
8 KDMF
22 NDC API
17 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

13 Drugs in Development

13 Drugs in Development

FINISHED DOSAGE FORMULATIONS

613 FDF Dossiers, 262 FDA Orange Book, 232 Europe, 52 Canada, 30 South Africa, 37 Listed Dossiers

613 FDF Dossiers
262 FDA Orange Book
232 Europe
52 Canada
30 South Africa
37 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG, TABLET;ORAL - 20MG, TABLET;ORAL - 5MG, TABLET, EXTENDED RELEASE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION, EXTENDED RELEASE;ORAL - 5MG/ML, CAPSULE, EXTENDED RELEASE;ORAL - 10MG, CAPSULE, EXTENDED RELEASE;ORAL - 15MG, CAPSULE, EXTENDED RELEASE;ORAL - 20MG, CAPSULE, EXTENDED RELEASE;ORAL - 30MG, CAPSULE, EXTENDED RELEASE;ORAL - 40MG, CAPSULE, EXTENDED RELEASE;ORAL - 50MG, CAPSULE, EXTENDED RELEASE;ORAL - 60MG, TABLET, EXTENDED RELEASE, CHEWABLE;ORAL - 20MG, TABLET, EXTENDED RELEASE, CHEWABLE;ORAL - 30MG, TABLET, EXTENDED RELEASE, CHEWABLE;ORAL - 40MG, TABLET, EXTENDED RELEASE;ORAL - 18MG, TABLET, EXTENDED RELEASE;ORAL - 27MG, TABLET, EXTENDED RELEASE;ORAL - 36MG, TABLET, EXTENDED RELEASE;ORAL - 54MG, CAPSULE, EXTENDED RELEASE;ORAL - 10MG, CAPSULE, EXTENDED RELEASE;ORAL - 20MG, CAPSULE, EXTENDED RELEASE;ORAL - 30MG, CAPSULE, EXTENDED RELEASE;ORAL - 40MG, CAPSULE, EXTENDED RELEASE;ORAL - 50MG, CAPSULE, EXTENDED RELEASE;ORAL - 60MG, SOLUTION;ORAL - 10MG/5ML, SOLUTION;ORAL - 5MG/5ML, TABLET, CHEWABLE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, CHEWABLE;ORAL - 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, CHEWABLE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 10MG
TABLET;ORAL - 20MG
TABLET;ORAL - 5MG
TABLET, EXTENDED RELEASE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
FOR SUSPENSION, EXTENDED RELEASE;ORAL - 5MG/ML
CAPSULE, EXTENDED RELEASE;ORAL - 10MG
CAPSULE, EXTENDED RELEASE;ORAL - 15MG
CAPSULE, EXTENDED RELEASE;ORAL - 20MG
CAPSULE, EXTENDED RELEASE;ORAL - 30MG
CAPSULE, EXTENDED RELEASE;ORAL - 40MG
CAPSULE, EXTENDED RELEASE;ORAL - 50MG
CAPSULE, EXTENDED RELEASE;ORAL - 60MG
TABLET, EXTENDED RELEASE, CHEWABLE;ORAL - 20MG
TABLET, EXTENDED RELEASE, CHEWABLE;ORAL - 30MG
TABLET, EXTENDED RELEASE, CHEWABLE;ORAL - 40MG
TABLET, EXTENDED RELEASE;ORAL - 18MG
TABLET, EXTENDED RELEASE;ORAL - 27MG
TABLET, EXTENDED RELEASE;ORAL - 36MG
TABLET, EXTENDED RELEASE;ORAL - 54MG
CAPSULE, EXTENDED RELEASE;ORAL - 10MG
CAPSULE, EXTENDED RELEASE;ORAL - 20MG
CAPSULE, EXTENDED RELEASE;ORAL - 30MG
CAPSULE, EXTENDED RELEASE;ORAL - 40MG
CAPSULE, EXTENDED RELEASE;ORAL - 50MG
CAPSULE, EXTENDED RELEASE;ORAL - 60MG
SOLUTION;ORAL - 10MG/5ML
SOLUTION;ORAL - 5MG/5ML
TABLET, CHEWABLE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, CHEWABLE;ORAL - 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, CHEWABLE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 3 Evonik, 8 Rochem International Inc, 19 SPI Pharma, 2 Seqens, 18 DKSH, 1 Jai Radhe Sales, 2 Pharm-RX Chemical, 7 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 15 Gangwal Healthcare, 10 Nanjing Well Pharmaceutical, 3 Pfanstiehl, 4 ACG Worldwide, 12 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 38 BASF, 1 Bioplus Life Sciences, 20 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 11 Gangwal Chemicals, 2 Hayashibara, 15 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 39 Kerry, 5 Kima Chemical, 6 Lonza Capsugel, 20 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 9 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 36 Roquette, 9 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 6 The Dow Chemical Company, 2 Valens Pharmachem, 3 Vasa Pharmachem, 3 Vertellus, 2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

111 Fillers, Diluents & Binders, 84 Coating Systems & Additives, 54 Controlled & Modified Release, 50 Thickeners and Stabilizers, 45 Direct Compression, 37 Taste Masking, 31 Solubilizers, 30 Granulation, 30 Film Formers & Plasticizers, 27 Topical, 27 Parenteral, 27 Lubricants & Glidants, 27 Disintegrants & Superdisintegrants, 22 Chewable & Orodispersible Aids, 19 Co-Processed Excipients, 10 Emulsifying Agents, 9 Empty Capsules, 8 API Stability Enhancers, 7 Rheology Modifiers, 5 Coloring Agents, 4 Vegetarian Capsules, 3 Surfactant & Foaming Agents, 1 Soft Gelatin

111 Fillers, Diluents & Binders
84 Coating Systems & Additives
54 Controlled & Modified Release
50 Thickeners and Stabilizers
45 Direct Compression
37 Taste Masking
31 Solubilizers
30 Granulation
30 Film Formers & Plasticizers
27 Topical
27 Parenteral
27 Lubricants & Glidants
27 Disintegrants & Superdisintegrants
22 Chewable & Orodispersible Aids
19 Co-Processed Excipients
10 Emulsifying Agents
9 Empty Capsules
8 API Stability Enhancers
7 Rheology Modifiers
5 Coloring Agents
4 Vegetarian Capsules
3 Surfactant & Foaming Agents
1 Soft Gelatin

DIGITAL CONTENT

6 DATA COMPILATION #PharmaFlow, 70 NEWS #PharmaBuzz

6 DATA COMPILATION #PharmaFlow
70 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

9 US Medicaid Prescriptions, 150 Finished Drug Prices, 2 Annual Reports

9 US Medicaid Prescriptions
150 Finished Drug Prices
2 Annual Reports

MARKET PLACE

10 APIs, 2 FDF Dossiers

10 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

191 US Patents, 6 US Exclusivities, 25 Health Canada Patents

191 US Patents
6 US Exclusivities
25 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 2 USP, 3 Others

3 EDQM
2 USP
3 Others

$ API Ref.Price (USD/KG) : 690 Xls

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01 5Adcock Ingram Limited

02 4Austell Laboratories (Pty) Ltd

03 1Biotech Laboratories (Pty) Ltd

04 4Janssen Pharmaceutica (Pty) Ltd

05 4Mylan (Pty) Ltd

06 4Pharma Dynamics (Pty) Ltd

07 8Sandoz SA (Pty) Ltd

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30 All

01 4METHYLPHENIDATE HYDROCHLORIDE

02 9Methylphenidate Hydrochloride

03 13Methylphenidate hydrochloride

04 4methylphenidate hydrochloride

filter Dosage Form Reset all filters

30 All

01 5CAP

02 4SRT

03 21TAB

filter Brand Name Reset all filters

30 All

01 1CONTRAMYL XR 18 mg

02 1CONTRAMYL XR 27 mg

03 1CONTRAMYL XR 36 mg

04 1CONTRAMYL XR 54 mg

05 1Medikinet MR 10mg

06 1Medikinet MR 20mg

07 1Medikinet MR 30mg

08 1Medikinet MR 40mg

09 1Medikinet MR 5mg

10 1Mefedinel 18

11 1Mefedinel 27

12 1Mefedinel 36

13 1Mefedinel 54

14 1Meglarat PR 18mg

15 1Meglarat PR 27mg

16 1Meglarat PR 36mg

17 1Meglarat PR 54mg

18 1Methylphenidate 10 Biotech

19 1Methylphenidate Unicorn 18

20 1Methylphenidate Unicorn 27

21 1Methylphenidate Unicorn 36

22 1Methylphenidate Unicorn 54

23 1Neucon 18 mg

24 1Neucon 27 mg

25 1Neucon 36 mg

26 1Neucon 54 mg

27 1Radd 18 mg

28 1Radd 27 mg

29 1Radd 36 mg

30 1Radd 54 mg

Veranova Methylphenidate Hydrochloride

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01

Adcock Ingram Limited

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Regulatory Info : Generic

Registration Country : South Africa

Methylphenidate Hydrochloride

Brand Name : Medikinet MR 20mg

Dosage Form : CAP

Dosage Strength : 20mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Adcock Ingram Limited

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Regulatory Info : Generic

Registration Country : South Africa

Methylphenidate Hydrochloride

Brand Name : Medikinet MR 5mg

Dosage Form : CAP

Dosage Strength : 5mg

Packaging : 30X1mg

Approval Date :

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Regulatory Info : Generic

Registration Country : South Africa

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03

Adcock Ingram Limited

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Adcock Ingram Limited

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Regulatory Info : Generic

Registration Country : South Africa

Methylphenidate Hydrochloride

Brand Name : Medikinet MR 10mg

Dosage Form : CAP

Dosage Strength : 10mg

Packaging : 30X1mg

Approval Date :

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Regulatory Info : Generic

Registration Country : South Africa

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04

Adcock Ingram Limited

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Adcock Ingram Limited

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Regulatory Info : Generic

Registration Country : South Africa

Methylphenidate Hydrochloride

Brand Name : Medikinet MR 30mg

Dosage Form : CAP

Dosage Strength : 30mg

Packaging : 30X1mg

Approval Date :

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Regulatory Info : Generic

Registration Country : South Africa

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05

Adcock Ingram Limited

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Adcock Ingram Limited

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Regulatory Info : Generic

Registration Country : South Africa

Methylphenidate Hydrochloride

Brand Name : Medikinet MR 40mg

Dosage Form : CAP

Dosage Strength : 40mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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06

Austell Laboratories (Pty) Ltd

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Austell Laboratories (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Methylphenidate Hydrochloride

Brand Name : Meglarat PR 18mg

Dosage Form : TAB

Dosage Strength : 18mg

Packaging : 30X1mg

Approval Date :

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Regulatory Info : Generic

Registration Country : South Africa

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Austell Laboratories (Pty) Ltd

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Austell Laboratories (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Methylphenidate Hydrochloride

Brand Name : Meglarat PR 27mg

Dosage Form : TAB

Dosage Strength : 27mg

Packaging : 30X1mg

Approval Date :

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Regulatory Info : Generic

Registration Country : South Africa

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08

Austell Laboratories (Pty) Ltd

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Austell Laboratories (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Methylphenidate Hydrochloride

Brand Name : Meglarat PR 36mg

Dosage Form : TAB

Dosage Strength : 36mg

Packaging : 30X1mg

Approval Date :

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Regulatory Info : Generic

Registration Country : South Africa

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09

Austell Laboratories (Pty) Ltd

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Austell Laboratories (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Methylphenidate Hydrochloride

Brand Name : Meglarat PR 54mg

Dosage Form : TAB

Dosage Strength : 54mg

Packaging : 30X1mg

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Regulatory Info : Generic

Registration Country : South Africa

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Biotech Laboratories (Pty) Ltd

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Biotech Laboratories (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Methylphenidate hydrochloride

Brand Name : Methylphenidate 10 Biotech

Dosage Form : TAB

Dosage Strength : 10MG

Packaging : 30X1MG

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Regulatory Info : Generic

Registration Country : South Africa

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