Parke Davis Brand of Sertraline Hydrochloride | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Parke Davis Brand Of Sertraline Hydrochloride
South Africa

AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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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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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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FAMAR CDMO- From early development to commercial manufacturing.

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evonik-m-2025-09-08

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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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Parke Davis Brand of Sertraline Hydrochloride

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

83 API Suppliers, 25 USDMF, 27 CEP/COS, 7 JDMF, 17 EU WC, 16 KDMF, 15 NDC API, 37 Listed Suppliers, $ API Reference Price

83 API Suppliers
25 USDMF
27 CEP/COS
7 JDMF
17 EU WC
16 KDMF
15 NDC API
37 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

58 Drugs in Development

58 Drugs in Development

INTERMEDIATES

18 Intermediate Suppliers

18 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

560 FDF Dossiers, 98 FDA Orange Book, 255 Europe, 54 Canada, 68 Australia, 21 South Africa, 64 Listed Dossiers

560 FDF Dossiers
98 FDA Orange Book
255 Europe
54 Canada
68 Australia
21 South Africa
64 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 100MG BASE, TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 25MG BASE, TABLET;ORAL - EQ 50MG BASE

TABLET;ORAL - EQ 100MG BASE
TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 25MG BASE
TABLET;ORAL - EQ 50MG BASE

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 4 SPI Pharma, 5 DKSH, 6 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 Kirsch Pharma, 1 ACG Worldwide, 7 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 23 BASF, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 2 Finar, 12 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures, 4 Ingredion Pharma Solutions, 21 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 12 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 4 Novo Excipients, 3 Pharmatrans-Sanaq, 6 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 13 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 11 Sigachi Industries, 4 Silverline Chemicals, 1 Symrise, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

61 Fillers, Diluents & Binders, 47 Coating Systems & Additives, 28 Disintegrants & Superdisintegrants, 27 Direct Compression, 26 Solubilizers, 26 Controlled & Modified Release, 25 Granulation, 23 Thickeners and Stabilizers, 21 Topical, 19 Film Formers & Plasticizers, 17 Parenteral, 16 Lubricants & Glidants, 13 Co-Processed Excipients, 8 Taste Masking, 8 Emulsifying Agents, 7 API Stability Enhancers, 7 Rheology Modifiers, 7 Chewable & Orodispersible Aids, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 4 Coloring Agents

61 Fillers, Diluents & Binders
47 Coating Systems & Additives
28 Disintegrants & Superdisintegrants
27 Direct Compression
26 Solubilizers
26 Controlled & Modified Release
25 Granulation
23 Thickeners and Stabilizers
21 Topical
19 Film Formers & Plasticizers
17 Parenteral
16 Lubricants & Glidants
13 Co-Processed Excipients
8 Taste Masking
8 Emulsifying Agents
7 API Stability Enhancers
7 Rheology Modifiers
7 Chewable & Orodispersible Aids
5 Empty Capsules
4 Vegetarian Capsules
4 Surfactant & Foaming Agents
4 Coloring Agents

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 1 Stock Recap #PipelineProspector, 31 News #PharmaBuzz

1 Data Compilation #PharmaFlow
1 Stock Recap #PipelineProspector
31 News #PharmaBuzz

GLOBAL SALES INFORMATION

19 US Medicaid Prescriptions, 217 Regulatory FDF Prices, 10 Annual Reports

19 US Medicaid Prescriptions
217 Regulatory FDF Prices
10 Annual Reports

MARKET PLACE

19 APIs, 6 FDF Dossiers

19 APIs
6 FDF Dossiers

PATENTS & EXCLUSIVITIES

2 US Exclusivities, 5 Health Canada Patents

2 US Exclusivities
5 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 2 USP, 14 Others

4 EDQM
2 USP
14 Others

ANALYTICAL

1 Analytical Methods

1 Analytical Methods

$ API Ref.Price (USD/KG) : 122 Xls

Filters

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21 All

01 2Arrow Pharma South Africa (Pty) Ltd

02 2Aurobindo Pharma (Pty) Ltd

03 2Austell Laboratories (Pty) Ltd

04 2Be Tabs Pharmaceuticals (Pty) Ltd

05 2Cipla Medpro (Pty) Ltd

06 2Pharma Dynamics (Pty) Ltd

07 3Ranbaxy Pharmaceuticals (Pty) Ltd

08 2Trinity Pharma (Pty) Ltd

09 2Unimed Healthcare (Pty) Ltd

10 1Viatris Healthcare (Pty) Ltd

11 1Viatris South Africa (Pty) Ltd

filter Active Ingredients Reset all filters

21 All

01 18Sertraline

02 2Sertraline HCl

03 1Setraline Hydrochloride

filter Dosage Form Reset all filters

21 All

01 3FCT

02 18TAB

filter Brand Name Reset all filters

21 All

01 1Arrow Sertraline 100

02 1Arrow Sertraline 50

03 1Aurolift 100mg

04 1Aurolift 50mg

05 1Austell Sertraline 50 Mg

06 1Austell Setraline 100 Mg

07 1Dyna Sertraline 100

08 1Dyna Sertraline 50

09 1Serdep 100

10 1Serdep-50

11 1Serlife 100

12 1Serlife 50

13 1Sermax 100

14 1Sermax 50

15 1Sertra Tablets 50mg

16 1TRALIDEP 100

17 1TRALIDEP 50

18 1Zolid 100 mg

19 1Zolid 50 mg

20 1Zoloft Tablets 50mg

21 1Zosert 50

List of Suppliers

Product Main Page

01

Arrow Pharma South Africa (Pty) Ltd

ECRM CMO & Packaging

Not Confirmed

Arrow Pharma South Africa (Pty) Ltd

ECRM CMO & Packaging

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Arrow Sertraline 100

Dosage Form : TAB

Dosage Strength : 100mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Arrow Pharma South Africa (Pty) Ltd

ECRM CMO & Packaging

Not Confirmed

Arrow Pharma South Africa (Pty) Ltd

ECRM CMO & Packaging

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Arrow Sertraline 50

Dosage Form : TAB

Dosage Strength : 50mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Aurobindo Pharma (Pty) Ltd

ECRM CMO & Packaging

Not Confirmed

Aurobindo Pharma (Pty) Ltd

ECRM CMO & Packaging

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Sertraline HCl

Brand Name : Aurolift 100mg

Dosage Form : TAB

Dosage Strength : 100mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Aurobindo Pharma (Pty) Ltd

ECRM CMO & Packaging

Not Confirmed

Aurobindo Pharma (Pty) Ltd

ECRM CMO & Packaging

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Sertraline HCl

Brand Name : Aurolift 50mg

Dosage Form : TAB

Dosage Strength : 50mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Austell Laboratories (Pty) Ltd

BIOHK2025

Not Confirmed

Austell Laboratories (Pty) Ltd

BIOHK2025

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Austell Setraline 100 Mg

Dosage Form : TAB

Dosage Strength : 100mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Austell Laboratories (Pty) Ltd

BIOHK2025

Not Confirmed

Austell Laboratories (Pty) Ltd

BIOHK2025

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Setraline Hydrochloride

Brand Name : Austell Sertraline 50 Mg

Dosage Form : TAB

Dosage Strength : 50mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Be Tabs Pharmaceuticals (Pty) Ltd

BIOHK2025

Not Confirmed

Be Tabs Pharmaceuticals (Pty) Ltd

BIOHK2025

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Sermax 100

Dosage Form : TAB

Dosage Strength : 100mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Website

Corporate PDF

08

Be Tabs Pharmaceuticals (Pty) Ltd

BIOHK2025

Not Confirmed

Be Tabs Pharmaceuticals (Pty) Ltd

BIOHK2025

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Sermax 50

Dosage Form : TAB

Dosage Strength : 50mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Website

Corporate PDF

09

Cipla Medpro (Pty) Ltd

ECRM CMO & Packaging

Not Confirmed

Cipla Medpro (Pty) Ltd

ECRM CMO & Packaging

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Serdep-50

Dosage Form : TAB

Dosage Strength : 50mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Cipla Medpro (Pty) Ltd

ECRM CMO & Packaging

Not Confirmed

Cipla Medpro (Pty) Ltd

ECRM CMO & Packaging

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Serdep 100

Dosage Form : TAB

Dosage Strength : 100mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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