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

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Oxybutynin Hydrochloride
South Africa

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

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Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.

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xyz-pharma-m-2024-10-07

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With Fermion, start the journey of your innovative API.

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Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.

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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 Intermediates Suppliers

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TABLET, EXTENDED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;TRANSDERMAL - 10% (100MG/PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 7 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 14 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 Capital Farma, 1 ACG Worldwide, 12 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 8 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, 2 Valens Pharmachem, 5 Vasa Pharmachem, 1 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

89 Fillers, Diluents & Binders, 64 Coating Systems & Additives, 44 Direct Compression, 42 Controlled & Modified Release, 29 Disintegrants & Superdisintegrants, 28 Granulation, 28 Solubilizers, 27 Taste Masking, 26 Thickeners and Stabilizers, 26 Film Formers & Plasticizers, 25 Parenteral, 25 Lubricants & Glidants, 20 Co-Processed Excipients, 17 Topical, 16 Chewable & Orodispersible Aids, 10 Emulsifying Agents, 7 API Stability Enhancers, 5 Surfactant & Foaming Agents, 5 Coloring Agents, 5 Rheology Modifiers, 5 Empty Capsules, 4 Vegetarian Capsules, 1 Soft Gelatin

89 Fillers, Diluents & Binders
64 Coating Systems & Additives
44 Direct Compression
42 Controlled & Modified Release
29 Disintegrants & Superdisintegrants
28 Granulation
28 Solubilizers
27 Taste Masking
26 Thickeners and Stabilizers
26 Film Formers & Plasticizers
25 Parenteral
25 Lubricants & Glidants
20 Co-Processed Excipients
17 Topical
16 Chewable & Orodispersible Aids
10 Emulsifying Agents
7 API Stability Enhancers
5 Surfactant & Foaming Agents
5 Coloring Agents
5 Rheology Modifiers
5 Empty Capsules
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) : 648 Xls

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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

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01

iPharma (Pty) Ltd

Pharma, Lab & Chemical Expo

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iPharma (Pty) Ltd

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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

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02

Janssen Pharmaceutica (Pty) Ltd

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Janssen Pharmaceutica (Pty) Ltd

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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

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03

Janssen Pharmaceutica (Pty) Ltd

Pharma, Lab & Chemical Expo

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Janssen Pharmaceutica (Pty) Ltd

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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

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Mylan (Pty) Ltd

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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

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05

Mylan (Pty) Ltd

Pharma, Lab & Chemical Expo

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Mylan (Pty) Ltd

Pharma, Lab & Chemical Expo

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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

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