Prexan | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Prexan

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ACTIVE PHARMA INGREDIENTS

59 API Suppliers, 22 USDMF, 7 CEP/COS, 3 EU WC, 34 KDMF, 10 NDC API, 11 Listed Suppliers

DEVELOPMENTS

34 Drugs in Development

34 Drugs in Development

FINISHED DOSAGE FORMULATIONS

165 FDF Dossiers, 85 FDA Orange Book, 24 Europe, 18 Canada, 4 South Africa, 34 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 500MG BASE, TABLET;ORAL - 220MG, TABLET, EXTENDED RELEASE;ORAL - EQ 375MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 500MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 750MG BASE, TABLET;ORAL - 25MG;220MG, CAPSULE;ORAL - EQ 200MG BASE, TABLET;ORAL - 500MG;EQ 85MG BASE, TABLET;ORAL - 60MG;EQ 10MG BASE

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 11 Evonik, 3 Rochem International Inc, 20 SPI Pharma, 11 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 11 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 7 Kirsch Pharma, 2 Cerata Pharmaceuticals LLP, 4 Dr. Paul Lohmann GmbH & Co. KGaA, 4 ACG Worldwide, 11 Actylis, 2 Aeon Procare, 2 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 3 Ashland, 33 BASF, 1 CD Formulation, 3 Clariant, 17 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 2 Finar, 13 Gangwal Chemicals, 1 Gloria Interchem, 9 Ideal Cures, 5 Ingredion Pharma Solutions, 1 JJ Chemicals, 22 Kerry, 4 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 20 Microlex e.U, 1 Nanjing Bold Chemical, 1 Neelkanth MineChem, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 4 Novo Excipients, 4 Pharmatrans-Sanaq, 8 Pluviaendo, 4 Prachin Pharmachem, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 38 Roquette, 13 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 Silverline Chemicals, 3 The Dow Chemical Company, 3 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

90 Fillers, Diluents & Binders, 62 Coating Systems & Additives, 44 Thickeners and Stabilizers, 44 Controlled & Modified Release, 44 Disintegrants & Superdisintegrants, 42 Solubilizers, 40 Direct Compression, 34 Granulation, 33 Parenteral, 29 Film Formers & Plasticizers, 26 Topical, 26 Taste Masking, 23 Lubricants & Glidants, 21 Chewable & Orodispersible Aids, 17 Co-Processed Excipients, 11 API Stability Enhancers, 10 Emulsifying Agents, 9 Empty Capsules, 8 Rheology Modifiers, 6 Surfactant & Foaming Agents, 4 Vegetarian Capsules, 2 Coloring Agents, 1 Soft Gelatin

DIGITAL CONTENT

44 News #PharmaBuzz

44 News #PharmaBuzz

GLOBAL SALES INFORMATION

14 US Medicaid Prescriptions, 4 Regulatory FDF Prices

MARKET PLACE

44 APIs, 2 FDF Dossiers

PATENTS & EXCLUSIVITIES

12 US Patents, 4 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 1 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

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List of Suppliers

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01

Bayer (Pty) Ltd

PEGS Boston Summit

Bayer AG manufactures innovative APIs and pharmaceutical formulations across diverse therapeutic areas.

Contact Supplier

Contact Supplier

Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Naproxen Sodium

Brand Name : Aleve

Dosage Form : CAP

Dosage Strength : 200mg

Packaging : 10X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Bayer (Pty) Ltd

PEGS Boston Summit

Bayer AG manufactures innovative APIs and pharmaceutical formulations across diverse therapeutic areas.

Contact Supplier

Contact Supplier

Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Naproxen Sodium

Brand Name : Aleve

Dosage Form : CAP

Dosage Strength : 200mg

Packaging : 20X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Bayer (Pty) Ltd

PEGS Boston Summit

Bayer AG manufactures innovative APIs and pharmaceutical formulations across diverse therapeutic areas.

Contact Supplier

Contact Supplier

Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Naproxen Sodium

Brand Name : Aleve

Dosage Form : TAB

Dosage Strength : 220mg

Packaging : 12X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Bayer (Pty) Ltd

PEGS Boston Summit

Bayer AG manufactures innovative APIs and pharmaceutical formulations across diverse therapeutic areas.

Contact Supplier

Contact Supplier

Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Naproxen Sodium

Brand Name : Aleve

Dosage Form : TAB

Dosage Strength : 220mg

Packaging : 24X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.