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

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Glycopyrrolate
South Africa

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Glycopyrrolate

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

64 API Suppliers, 23 USDMF, 9 CEP/COS, 2 JDMF, 6 EU WC, 6 KDMF, 22 NDC API, 31 Listed Suppliers, $ API Reference Price

64 API Suppliers
23 USDMF
9 CEP/COS
2 JDMF
6 EU WC
6 KDMF
22 NDC API
31 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

35 Drugs in Development

35 Drugs in Development

FINISHED DOSAGE FORMULATIONS

148 FDF Dossiers, 87 FDA Orange Book, 22 Europe, 13 Canada, 2 Australia, 7 South Africa, 17 Listed Dossiers

148 FDF Dossiers
87 FDA Orange Book
22 Europe
13 Canada
2 Australia
7 South Africa
17 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 1MG, TABLET;ORAL - 2MG, INJECTABLE;INJECTION - 0.2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, POWDER;INHALATION - 15.6MCG/INH, POWDER;INHALATION - 15.6MCG/INH;27.5MCG/INH, SOLUTION;INHALATION - 25MCG/ML, TABLET, ORALLY DISINTEGRATING;ORAL - 1.7MG

TABLET;ORAL - 1MG
TABLET;ORAL - 2MG
INJECTABLE;INJECTION - 0.2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
POWDER;INHALATION - 15.6MCG/INH
POWDER;INHALATION - 15.6MCG/INH;27.5MCG/INH
SOLUTION;INHALATION - 25MCG/ML
TABLET, ORALLY DISINTEGRATING;ORAL - 1.7MG

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 2 Rochem International Inc, 6 SPI Pharma, 1 DKSH, 4 Faran Shimi Pharmaceutical, 4 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 8 Actylis, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 10 BASF, 6 DFE Pharma, 3 Finar, 5 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 27 Kerry, 12 Microlex e.U, 1 Nippon Fine Chemical, 1 Novo Excipients, 3 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 26 Roquette, 1 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

68 Fillers, Diluents & Binders, 22 Direct Compression, 17 Disintegrants & Superdisintegrants, 16 Parenteral, 16 Granulation, 14 Co-Processed Excipients, 14 Film Formers & Plasticizers, 14 Thickeners and Stabilizers, 11 Taste Masking, 11 Lubricants & Glidants, 10 Coating Systems & Additives, 10 Solubilizers, 9 Controlled & Modified Release, 7 Topical, 7 Chewable & Orodispersible Aids, 3 Emulsifying Agents, 1 Soft Gelatin, 1 API Stability Enhancers, 1 Surfactant & Foaming Agents, 1 Rheology Modifiers, 1 Dry Powder Inhalation

68 Fillers, Diluents & Binders
22 Direct Compression
17 Disintegrants & Superdisintegrants
16 Parenteral
16 Granulation
14 Co-Processed Excipients
14 Film Formers & Plasticizers
14 Thickeners and Stabilizers
11 Taste Masking
11 Lubricants & Glidants
10 Coating Systems & Additives
10 Solubilizers
9 Controlled & Modified Release
7 Topical
7 Chewable & Orodispersible Aids
3 Emulsifying Agents
1 Soft Gelatin
1 API Stability Enhancers
1 Surfactant & Foaming Agents
1 Rheology Modifiers
1 Dry Powder Inhalation

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 113 News #PharmaBuzz

1 Data Compilation #PharmaFlow
113 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 27 Regulatory FDF Prices, 25 Annual Reports

1 US Medicaid Prescriptions
27 Regulatory FDF Prices
25 Annual Reports

MARKET PLACE

24 APIs, 1 FDF Dossiers

24 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

31 US Patents, 4 Health Canada Patents

31 US Patents
4 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 11 Others

3 EDQM
11 Others

$ API Ref.Price (USD/KG) : 25,925 Xls

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7 All

01 2Pharmacare Limited, Woodmead

02 4Novartis South Africa (Pty) Ltd

03 1Umsebe Healthcare

filter Active Ingredients Reset all filters

7 All

01 1Glycopyrronium

02 6Glycopyrronium Bromide

filter Dosage Form Reset all filters

7 All

01 4CPS

02 3INJ

filter Brand Name Reset all filters

7 All

01 1Cholstyq

02 1Robinul 1 ml Injectable

03 1Robinul 2 ml Injectable

04 1Seebri Breezhaler

05 1Ultibro Breezhaler

06 1Zimbus Breezhaler 150/50/160

07 1Zimbus Breezhaler 150/50/80

Inke Glycopyrronium Bromide

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01

Pharmacare Limited, Woodmead

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Glycopyrronium Bromide

Brand Name : Robinul 1 ml Injectable

Dosage Form : INJ

Dosage Strength : 0.2mg/ml

Packaging : 1X10mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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02

Pharmacare Limited, Woodmead

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Regulatory Info : Originator

Registration Country : South Africa

Glycopyrronium Bromide

Brand Name : Robinul 2 ml Injectable

Dosage Form : INJ

Dosage Strength : 0.2mg/ml

Packaging : 2X10mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Umsebe Healthcare

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Umsebe Healthcare

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Regulatory Info : Generic

Registration Country : South Africa

Glycopyrronium Bromide

Brand Name : Cholstyq

Dosage Form : INJ

Dosage Strength : 0.5mg/ml

Packaging : 1X10mg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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04

Novartis South Africa (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Glycopyrronium Bromide

Brand Name : Zimbus Breezhaler 150/50/80

Dosage Form : CPS

Dosage Strength : 50mcg

Packaging : 30X1mcg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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05

Novartis South Africa (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Glycopyrronium Bromide

Brand Name : Zimbus Breezhaler 150/50/160

Dosage Form : CPS

Dosage Strength : 50mcg

Packaging : 30X1mcg

Approval Date :

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Regulatory Info : Originator

Registration Country : South Africa

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Novartis South Africa (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Glycopyrronium Bromide

Brand Name : Seebri Breezhaler

Dosage Form : CPS

Dosage Strength : 50mcg

Packaging : 30X1mcg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Novartis South Africa (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Glycopyrronium

Brand Name : Ultibro Breezhaler

Dosage Form : CPS

Dosage Strength : 50mcg

Packaging : 30X1mcg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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