Glycopyrronium Bromide

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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

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- 2MG, INJECTABLE;INJECTION - 0.2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, POWDER;INHALATION - 15.6MCG/INH, POWDER;INHALATION - 15.6MCG/INH;27.5MCG/INH, SOLUTION;INHALATION - 25MCG/ML, TABLET,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

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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

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GLOBAL SALES INFORMATION

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

MARKET PLACE

23 APIs, 1 FDF Dossiers

PATENTS & EXCLUSIVITIES

32 US Patents, 4 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 5 USP, 11 Others

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USFDA APPLICATION NUMBER - 208437 / DOSAGE - SOLUTION;INHALATION - 25MCG/ML

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GLYCOPYRROLATE(UNII: V92SO9WP2I) (GLYCOPYRRONIUM - UNII:A14FB57V1D)	GLYCOPYRROLATE	25ug in 1

Inactive Ingredients

Ingredient Name	Holopack Verpackungstechnik GmbH	Sunovion Pharmaceuticals Inc.
Citric Acid Monohydrate(2968PHW8QP)
Hydrochloric Acid(QTT17582CB)
Sodium Chloride(451W47IQ8X)
Sodium Hydroxide(55X04QC32I)
Water(059QF0KO0R)

Drug Product Composition: Glycopyrronium Bromide