Glycopyrrolate

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ACTIVE PHARMA INGREDIENTS

47 API Suppliers, 23 USDMF, 9 CEP/COS, 2 JDMF, 6 EU WC, 5 KDMF, 20 NDC API, 30 Listed Suppliers, $ API Reference Price

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33 Drugs in Development

33 Drugs in Development

FINISHED DOSAGE FORMULATIONS

147 FDF Dossiers, 86 FDA Orange Book, 22 Europe, 13 Canada, 1 Australia, 7 South Africa, 18 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- 2MG, INJECTABLE;INJECTION - 0.2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, POWDER;INHALATION - 15.6MCG/INH, POWDER;INHALATION - 15.6MCG/INH;27.5MCG/INH, SOLUTION;INHALATION - 25MCG/ML, TABLET,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

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc, 6 SPI Pharma, 1 DKSH, 4 Faran Shimi Pharmaceutical, 4 Boai NKY Pharmaceuticals Ltd, 13 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

72 Fillers, Diluents & Binders, 32 Direct Compression, 19 Disintegrants & Superdisintegrants, 19 Co-Processed Excipients, 16 Granulation, 15 Thickeners and Stabilizers, 15 Parenteral, 14 Film Formers & Plasticizers, 12 Lubricants & Glidants, 11 Taste Masking, 10 Solubilizers, 10 Controlled & Modified Release, 10 Coating Systems & Additives, 7 Chewable & Orodispersible Aids, 6 Topical, 3 Emulsifying Agents, 1 Soft Gelatin, 1 API Stability Enhancers, 1 Surfactant & Foaming Agents, 1 Rheology Modifiers, 1 Dry Powder Inhalation

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1 US Medicaid Prescriptions, 27 Finished Drug Prices, 25 Annual Reports

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23 APIs, 1 FDF Dossiers

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32 US Patents, 4 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 5 USP, 11 Others

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USFDA APPLICATION NUMBER - 215019 / DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 1.7MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GLYCOPYRROLATE(UNII: V92SO9WP2I) (Glycopyrronium - UNII:A14FB57V1D)	GLYCOPYRROLATE	0.85mg \| 1.7mg

Drug Product Composition: Glycopyrrolate

Glycopyrrolate

Glycopyrrolate

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

47 API Suppliers

23 USDMF

9 CEP/COS

2 JDMF

6 EU WC

5 KDMF

20 NDC API

30 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

33 Drugs in Development

FINISHED DOSAGE FORMULATIONS

147 FDF Dossiers

86 FDA Orange Book

22 Europe

13 Canada

1 Australia

7 South Africa

18 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

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc

6 SPI Pharma

1 DKSH

4 Faran Shimi Pharmaceutical

4 Boai NKY Pharmaceuticals Ltd

13 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

72 Fillers, Diluents & Binders

32 Direct Compression

19 Disintegrants & Superdisintegrants

19 Co-Processed Excipients

16 Granulation

15 Thickeners and Stabilizers

15 Parenteral

14 Film Formers & Plasticizers

12 Lubricants & Glidants

11 Taste Masking

10 Solubilizers

INJECTABLE;INJECTION - 0.2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons