Hydromorphone Hydrochloride

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

31 API Suppliers, 11 USDMF, 7 CEP/COS, 1 JDMF, 2 KDMF, 17 NDC API, 9 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

22 Drugs in Development

22 Drugs in Development

FINISHED DOSAGE FORMULATIONS

175 FDF Dossiers, 76 FDA Orange Book, 31 Europe, 6 Canada, 37 Australia, 5 South Africa, 20 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 0.2MG/ML, INJECTABLE;INJECTION - 0.5MG/0.5ML, INJECTABLE;INJECTION - 10MG/ML, INJECTABLE;INJECTION - 1MG/ML, INJECTABLE;INJECTION - 2MG/ML, INJECTABLE;INJECTION - 4MG/ML, SOLUTION;ORAL - 5MG/5ML, TABLET;ORAL - 2MG, TABLET;ORAL - 4MG, TABLET;ORAL - 8MG, TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 32MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Evonik, 2 Rochem International Inc, 15 SPI Pharma, 6 DKSH, 6 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 7 Kirsch Pharma, 1 ACG Worldwide, 11 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 26 BASF, 2 CD Formulation, 1 Clariant, 12 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 2 Finar, 11 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures, 2 Ingredion Pharma Solutions, 26 Kerry, 2 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 17 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 4 Novo Excipients, 3 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 24 Roquette, 12 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 3 Silverline Chemicals, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

72 Fillers, Diluents & Binders, 52 Coating Systems & Additives, 37 Direct Compression, 31 Thickeners and Stabilizers, 31 Parenteral, 30 Controlled & Modified Release, 29 Granulation, 28 Solubilizers, 27 Film Formers & Plasticizers, 20 Taste Masking, 20 Topical, 20 Disintegrants & Superdisintegrants, 18 Lubricants & Glidants, 16 Chewable & Orodispersible Aids, 14 Co-Processed Excipients, 9 Emulsifying Agents, 7 API Stability Enhancers, 6 Rheology Modifiers, 5 Coloring Agents, 5 Empty Capsules, 5 Surfactant & Foaming Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 58 News #PharmaBuzz

GLOBAL SALES INFORMATION

17 US Medicaid Prescriptions, 35 Regulatory FDF Prices

MARKET PLACE

1 APIs, 2 FDF Dossiers

PATENTS & EXCLUSIVITIES

14 US Patents, 1 US Exclusivities

REF. STANDARDS & IMPURITIES

2 EDQM, 5 Others

$ Xls

Filters

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USFDA APPLICATION NUMBER - 19891 / DOSAGE - SOLUTION;ORAL - 5MG/5ML

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
hydromorphone hydrochloride(UNII: L960UP2KRW) (hydromorphone - UNII:Q812464R06)	hydromorphone hydrochloride	8mg \| 4mg \| 2mg \| 5mg in 5

Inactive Ingredients

Ingredient Name	Purdue Pharma LP	Lannett Company, Inc.
ANHYDROUS LACTOSE(3SY5LH9PMK)
D&C RED NO. 30(2S42T2808B)
D&C YELLOW NO. 10(35SW5USQ3G)
glycerin(PDC6A3C0OX)
MAGNESIUM STEARATE(70097M6I30)
METHYLPARABEN(A2I8C7HI9T)
PROPYLPARABEN(Z8IX2SC1OH)
SODIUM METABISULFITE(4VON5FNS3C)
sucrose(C151H8M554)
water(059QF0KO0R)

Drug Product Composition: Hydromorphone Hydrochloride