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

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Oxybutynin Hydrochloride
South Africa

Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

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

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xyz-pharma-m-2024-10-07

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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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xyz-pharma-m-2024-10-07

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Oxybutynin Hydrochloride

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

24 API Suppliers, 13 USDMF, 10 CEP/COS, 3 JDMF, 2 EU WC, 1 KDMF, 11 NDC API, 10 Listed Suppliers, $ API Reference Price

24 API Suppliers
13 USDMF
10 CEP/COS
3 JDMF
2 EU WC
1 KDMF
11 NDC API
10 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

INTERMEDIATES

2 API Suppliers

2 API Suppliers

FINISHED DOSAGE FORMULATIONS

94 FDF Dossiers, 61 FDA Orange Book, 12 Europe, 10 Canada, 5 South Africa, 6 Listed Dossiers

94 FDF Dossiers
61 FDA Orange Book
12 Europe
10 Canada
5 South Africa
6 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;TRANSDERMAL - 10% (100MG/PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
GEL;TRANSDERMAL - 10% (100MG/PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Evonik, 2 Rochem International Inc, 19 SPI Pharma, 2 Seqens, 5 DKSH, 2 Jai Radhe Sales, 1 Boai NKY Pharmaceuticals Ltd, 14 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 ACG Worldwide, 12 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 30 BASF, 1 Clariant, 14 Corel Pharma Chem, 7 DFE Pharma, 3 Doshion Polyscience, 2 Finar, 12 Gangwal Chemicals, 9 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 37 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 16 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 8 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 29 Roquette, 14 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 2 Valens Pharmachem, 5 Vasa Pharmachem, 1 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

90 Fillers, Diluents & Binders, 64 Coating Systems & Additives, 45 Direct Compression, 42 Controlled & Modified Release, 30 Disintegrants & Superdisintegrants, 28 Granulation, 28 Solubilizers, 27 Taste Masking, 26 Thickeners and Stabilizers, 26 Film Formers & Plasticizers, 25 Parenteral, 25 Lubricants & Glidants, 19 Co-Processed Excipients, 17 Topical, 16 Chewable & Orodispersible Aids, 10 Emulsifying Agents, 7 API Stability Enhancers, 5 Rheology Modifiers, 5 Empty Capsules, 5 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

90 Fillers, Diluents & Binders
64 Coating Systems & Additives
45 Direct Compression
42 Controlled & Modified Release
30 Disintegrants & Superdisintegrants
28 Granulation
28 Solubilizers
27 Taste Masking
26 Thickeners and Stabilizers
26 Film Formers & Plasticizers
25 Parenteral
25 Lubricants & Glidants
19 Co-Processed Excipients
17 Topical
16 Chewable & Orodispersible Aids
10 Emulsifying Agents
7 API Stability Enhancers
5 Rheology Modifiers
5 Empty Capsules
5 Surfactant & Foaming Agents
5 Coloring Agents
4 Vegetarian Capsules
1 Soft Gelatin

DIGITAL CONTENT

17 NEWS #PharmaBuzz

17 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 13 Finished Drug Prices

2 US Medicaid Prescriptions
13 Finished Drug Prices

MARKET PLACE

7 APIs

7 APIs

PATENTS & EXCLUSIVITIES

3 US Patents, 8 Health Canada Patents

3 US Patents
8 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 USP, 1 Others

1 USP
1 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 653 Xls

Filters

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5 All

01 2Janssen Pharmaceutica (Pty) Ltd

02 2Mylan (Pty) Ltd

03 1iPharma (Pty) Ltd

filter Active Ingredients Reset all filters

5 All

01 1Oxybutynin Hydrochloride

02 2Oxybutynin Hydrocholride

03 2Oxybutynin chloride 5 mg

filter Dosage Form Reset all filters

5 All

01 5TAB

filter Brand Name Reset all filters

5 All

01 1Lyrinel 10 mg

02 1Lyrinel 5 mg

03 2Mylan Oxybutynin 5

04 1Oxyrest

List of Suppliers

Product Main Page

01

iPharma (Pty) Ltd

2024 ACI Convention

Not Confirmed

iPharma (Pty) Ltd

2024 ACI Convention

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Oxybutynin Hydrochloride

Brand Name : Oxyrest

Dosage Form : TAB

Dosage Strength : 5mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Janssen Pharmaceutica (Pty) Ltd

2024 ACI Convention

Not Confirmed

Janssen Pharmaceutica (Pty) Ltd

2024 ACI Convention

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Oxybutynin Hydrocholride

Brand Name : Lyrinel 5 mg

Dosage Form : TAB

Dosage Strength : 5mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Janssen Pharmaceutica (Pty) Ltd

2024 ACI Convention

Not Confirmed

Janssen Pharmaceutica (Pty) Ltd

2024 ACI Convention

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Oxybutynin Hydrocholride

Brand Name : Lyrinel 10 mg

Dosage Form : TAB

Dosage Strength : 10mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Mylan (Pty) Ltd

2024 ACI Convention

Not Confirmed

Mylan (Pty) Ltd

2024 ACI Convention

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Oxybutynin chloride 5 mg

Brand Name : Mylan Oxybutynin 5

Dosage Form : TAB

Dosage Strength : 5mg

Packaging : 20X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Mylan (Pty) Ltd

2024 ACI Convention

Not Confirmed

Mylan (Pty) Ltd

2024 ACI Convention

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

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Oxybutynin chloride 5 mg

Brand Name : Mylan Oxybutynin 5

Dosage Form : TAB

Dosage Strength : 5mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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