Hydromorphone Hydrochloride

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ACTIVE PHARMA INGREDIENTS

20 API Suppliers, 11 USDMF, 7 CEP/COS, 1 JDMF, 2 KDMF, 23 NDC API, 9 Listed Suppliers, $ API Reference Price

FINISHED DOSAGE FORMULATIONS

219 FDF Dossiers, 76 FDA Orange Book, 36 Europe, 42 Canada, 40 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- 8MG, TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 32MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

1 Evonik, 2 Rochem International Inc, 14 SPI Pharma, 2 Seqens, 4 DKSH, 4 Faran Shimi Pharmaceutical, 6 Boai NKY Pharmaceuticals Ltd, 11 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 ACG Worldwide, 11 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 26 BASF, 1 Clariant, 12 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 11 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 7 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 39 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 17 Microlex e.U, 1 Nanjing Bold Chemical, 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, 11 Sigachi Industries, 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

89 Fillers, Diluents & Binders, 56 Coating Systems & Additives, 40 Direct Compression, 36 Controlled & Modified Release, 29 Film Formers & Plasticizers, 27 Solubilizers, 27 Parenteral, 26 Thickeners and Stabilizers, 24 Granulation, 21 Co-Processed Excipients, 19 Lubricants & Glidants, 18 Topical, 18 Taste Masking, 17 Disintegrants & Superdisintegrants, 13 Chewable & Orodispersible Aids, 8 Emulsifying Agents, 8 API Stability Enhancers, 5 Empty Capsules, 5 Coloring Agents, 4 Rheology Modifiers, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 1 Soft Gelatin

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 58 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 46 Finished Drug Prices

MARKET PLACE

1 APIs, 2 FDF Dossiers

PATENTS & EXCLUSIVITIES

14 US Patents, 3 US Exclusivities, 12 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 3 USP, 5 Others

$ Xls

Filters

Xls

USFDA APPLICATION NUMBER - 21217 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROMORPHONE HYDROCHLORIDE(UNII: L960UP2KRW) (HYDROMORPHONE - UNII:Q812464R06)	HYDROMORPHONE HYDROCHLORIDE	16mg

Inactive Ingredients

Ingredient Name	Lake Erie Medical DBA Quality Care Products LLC	Physicians Total Care, Inc.	SpecGx LLC	STAT Rx USA LLC
ANHYDROUS LACTOSE(3SY5LH9PMK)
BUTYLATED HYDROXYTOLUENE(1P9D0Z171K)
CELLULOSE ACETATE(3J2P07GVB6)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
FERROSOFERRIC OXIDE(XM0M87F357)
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
LACTOSE, ANHYDROUS(3SY5LH9PMK)
MAGNESIUM STEARATE(70097M6I30)
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)
POLYETHYLENE GLYCOL(3WJQ0SDW1A)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
POVIDONE(FZ989GH94E)
POVIDONE, UNSPECIFIED(FZ989GH94E)
POVIDONES(FZ989GH94E)
SODIUM CHLORIDE(451W47IQ8X)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)

Drug Product Composition: Hydromorphone Hydrochloride