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

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Tramadol Hydrochloride
South Africa

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

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Athena Tramadol Hydrochloride

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Midas Pharma provides expertise in developing and supplying APIs, finished products, and intermediates.

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Tramadol Hydrochloride

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

85 API Suppliers, 37 USDMF, 27 CEP/COS, 7 JDMF, 18 EU WC, 68 KDMF, 21 NDC API, 45 Listed Suppliers, $ API Reference Price

85 API Suppliers
37 USDMF
27 CEP/COS
7 JDMF
18 EU WC
68 KDMF
21 NDC API
45 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

15 Drugs in Development

15 Drugs in Development

INTERMEDIATES

2 Intermediates Suppliers

2 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

778 FDF Dossiers, 80 FDA Orange Book, 417 Europe, 34 Canada, 57 Australia, 42 South Africa, 148 Listed Dossiers

778 FDF Dossiers
80 FDA Orange Book
417 Europe
34 Canada
57 Australia
42 South Africa
148 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 325MG;37.5MG, TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 100MG, CAPSULE, EXTENDED RELEASE;ORAL - 150MG, CAPSULE, EXTENDED RELEASE;ORAL - 200MG, CAPSULE, EXTENDED RELEASE;ORAL - 300MG

TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 325MG;37.5MG
TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE, EXTENDED RELEASE;ORAL - 100MG
CAPSULE, EXTENDED RELEASE;ORAL - 150MG
CAPSULE, EXTENDED RELEASE;ORAL - 200MG
CAPSULE, EXTENDED RELEASE;ORAL - 300MG

RELATED EXCIPIENT COMPANIES

1 Minakem, 6 Evonik, 2 Rochem International Inc, 17 SPI Pharma, 2 Seqens, 10 DKSH, 1 Pharm-RX Chemical, 7 Faran Shimi Pharmaceutical, 11 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 14 Gangwal Healthcare, 10 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 34 BASF, 3 Clariant, 11 Corel Pharma Chem, 7 DFE Pharma, 2 Finar, 12 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 39 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 17 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 4 Novo Excipients, 5 Pharmatrans-Sanaq, 7 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 22 Roquette, 16 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 3 The Dow Chemical Company, 3 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

101 Fillers, Diluents & Binders, 62 Coating Systems & Additives, 49 Direct Compression, 45 Disintegrants & Superdisintegrants, 40 Controlled & Modified Release, 39 Thickeners and Stabilizers, 34 Solubilizers, 33 Granulation, 30 Lubricants & Glidants, 27 Topical, 23 Parenteral, 23 Film Formers & Plasticizers, 23 Co-Processed Excipients, 19 Taste Masking, 19 Chewable & Orodispersible Aids, 11 Emulsifying Agents, 9 Empty Capsules, 9 API Stability Enhancers, 7 Rheology Modifiers, 7 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules

101 Fillers, Diluents & Binders
62 Coating Systems & Additives
49 Direct Compression
45 Disintegrants & Superdisintegrants
40 Controlled & Modified Release
39 Thickeners and Stabilizers
34 Solubilizers
33 Granulation
30 Lubricants & Glidants
27 Topical
23 Parenteral
23 Film Formers & Plasticizers
23 Co-Processed Excipients
19 Taste Masking
19 Chewable & Orodispersible Aids
11 Emulsifying Agents
9 Empty Capsules
9 API Stability Enhancers
7 Rheology Modifiers
7 Surfactant & Foaming Agents
5 Coloring Agents
4 Vegetarian Capsules

DIGITAL CONTENT

4 DATA COMPILATION #PharmaFlow, 63 NEWS #PharmaBuzz

4 DATA COMPILATION #PharmaFlow
63 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 387 Finished Drug Prices

2 US Medicaid Prescriptions
387 Finished Drug Prices

MARKET PLACE

60 APIs, 27 FDF Dossiers

60 APIs
27 FDF Dossiers

PATENTS & EXCLUSIVITIES

9 US Patents, 1 US Exclusivities, 12 Health Canada Patents

9 US Patents
1 US Exclusivities
12 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 1 USP, 8 Others

3 EDQM
1 USP
8 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 69 Xls

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42 All

01 3Pharmacare Limited, Woodmead

02 1Adcock Ingram Limited

03 2Austell Laboratories (Pty) Ltd

04 9Janssen Pharmaceutica (Pty) Ltd

05 3Pharma Dynamics (Pty) Ltd

06 5Ranbaxy Pharmaceuticals (Pty) Ltd

07 6Sandoz SA (Pty) Ltd

08 4Unichem SA (Pty) Ltd

09 9Zydus Healthcare SA (Pty) Ltd

filter Active Ingredients Reset all filters

42 All

01 5Tramadol

02 1Tramadol Hydrochloride

03 24Tramadol Hydrochloride

04 11Tramadol hydrochloride

05 1Tromadol Hydrochloride

filter Dosage Form Reset all filters

42 All

01 14CAP

02 4FCT

03 9INJ

04 5SRT

05 1SUP

06 9TAB

filter Brand Name Reset all filters

42 All

01 2Austell Tramadol 50 Mg

02 1Dolotram 100

03 1Dolotram 50

04 2Dolotram Capsules

05 2Domadol

06 1Domadol 100 mg

07 1Domadol 50 mg

08 1Nobligan

09 1Patram

10 2Tamoltra

11 1Tamoltra Forte

12 1Tramacet

13 1Tramahexal

14 1Tramahexal 100Mg/2 Ml

15 1Tramahexal Capsules

16 1Tramahexal Co 37,5/325

17 1Tramahexal Sr 100

18 1Tramahexal Sr 150

19 1Tramahexal Sr 200

20 3Tramal

21 1Tramal 100

22 2Tramal Sr

23 1Tramaspen 100 Mg/2 Ml

24 2Tramaspen 50 mg

25 2Tramazac 50

26 1Tramazac Co 37,5

27 1Tramazac Co 37.5

28 1Tramazac Injection

29 1Tramazac™ SR 100

30 1Tramazac™ SR 150

31 1Tramazac™ SR 200

32 1Tramgesic Flashtabs

33 1ULTRACET

List of Suppliers

Product Main Page

01

Pharmacare Limited, Woodmead

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Tramadol Hydrochloride

Brand Name : Tramaspen 100 Mg/2 Ml

Dosage Form : INJ

Dosage Strength : 100mg/2 ml

Packaging : 2X5mg/2 ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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02

Pharmacare Limited, Woodmead

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Tramadol Hydrochloride

Brand Name : Tramaspen 50 mg

Dosage Form : CAP

Dosage Strength : 50mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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03

Pharmacare Limited, Woodmead

BIO Partnering at JPM

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Regulatory Info : Generic

Registration Country : South Africa

Tramadol Hydrochloride

Brand Name : Tramaspen 50 mg

Dosage Form : CAP

Dosage Strength : 50mg

Packaging : 20X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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04

Adcock Ingram Limited

BIO Partnering at JPM

Not Confirmed

Adcock Ingram Limited

BIO Partnering at JPM

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Tramadol Hydrochloride

Brand Name : Tramgesic Flashtabs

Dosage Form : TAB

Dosage Strength : 50mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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05

Austell Laboratories (Pty) Ltd

BIO Partnering at JPM

Not Confirmed

Austell Laboratories (Pty) Ltd

BIO Partnering at JPM

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Tramadol Hydrochloride

Brand Name : Austell Tramadol 50 Mg

Dosage Form : CAP

Dosage Strength : 50mg

Packaging : 20X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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06

Austell Laboratories (Pty) Ltd

BIO Partnering at JPM

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Austell Laboratories (Pty) Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Tramadol Hydrochloride

Brand Name : Austell Tramadol 50 Mg

Dosage Form : CAP

Dosage Strength : 50mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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07

Janssen Pharmaceutica (Pty) Ltd

BIO Partnering at JPM

Not Confirmed

Janssen Pharmaceutica (Pty) Ltd

BIO Partnering at JPM

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Tramadol Hydrochloride

Brand Name : Tramacet

Dosage Form : TAB

Dosage Strength : 45mg/0.45ml

Packaging : 60X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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08

Janssen Pharmaceutica (Pty) Ltd

BIO Partnering at JPM

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Janssen Pharmaceutica (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Tramadol Hydrochloride

Brand Name : Nobligan

Dosage Form : INJ

Dosage Strength : 100mg

Packaging : 2X5mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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09

Janssen Pharmaceutica (Pty) Ltd

BIO Partnering at JPM

Not Confirmed

Janssen Pharmaceutica (Pty) Ltd

BIO Partnering at JPM

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Regulatory Info : Originator

Registration Country : South Africa

Tramadol Hydrochloride

Brand Name : ULTRACET

Dosage Form : TAB

Dosage Strength : 50mg/0.5ml

Packaging : 60X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

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10

Janssen Pharmaceutica (Pty) Ltd

BIO Partnering at JPM

Not Confirmed

Janssen Pharmaceutica (Pty) Ltd

BIO Partnering at JPM

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Regulatory Info : Originator

Registration Country : South Africa

Tramadol Hydrochloride

Brand Name : Tramal

Dosage Form : CAP

Dosage Strength : 50mg

Packaging : 20X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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