Oxycodone Hydrochloride

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ACTIVE PHARMA INGREDIENTS

29 API Suppliers, 13 USDMF, 11 CEP/COS, 1 JDMF, 1 EU WC, 7 KDMF, 18 NDC API, 16 Listed Suppliers, $ API Reference Price

INTERMEDIATES

2 API Suppliers

2 API Suppliers

FINISHED DOSAGE FORMULATIONS

790 FDF Dossiers, 289 FDA Orange Book, 345 Europe, 49 Canada, 52 Australia, 17 South Africa, 38 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 5MG, SOLUTION;ORAL - 100MG/5ML, SOLUTION;ORAL - 5MG/5ML, SOLUTION;ORAL - 5MG/5ML, TABLET;ORAL - 5MG, TABLET;ORAL - 7.5MG, TABLET, EXTENDED RELEASE;ORAL - 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 13.5MG, CAPSULE, EXTENDED RELEASE;ORAL - 18MG, CAPSULE, EXTENDED RELEASE;ORAL - 27MG, CAPSULE, EXTENDED RELEASE;ORAL - 36MG, CAPSULE, EXTENDED RELEASE;ORAL - 9MG, TABLET, EXTENDED RELEASE;ORAL - 10MG, TABLET, EXTENDED RELEASE;ORAL - 15MG, TABLET, EXTENDED RELEASE;ORAL - 20MG, TABLET, EXTENDED RELEASE;ORAL - 30MG, TABLET, EXTENDED RELEASE;ORAL - 40MG, TABLET, EXTENDED RELEASE;ORAL - 60MG, TABLET, EXTENDED RELEASE;ORAL - 80MG, TABLET;ORAL - 325MG;5MG

RELATED EXCIPIENT COMPANIES

4 Evonik, 7 Rochem International Inc, 22 SPI Pharma, 2 Seqens, 18 DKSH, 2 Jai Radhe Sales, 2 Pharm-RX Chemical, 8 Boai NKY Pharmaceuticals Ltd, 16 Gangwal Healthcare, 8 Nanjing Well Pharmaceutical, 3 Pfanstiehl, 4 ACG Worldwide, 14 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 38 BASF, 1 Bioplus Life Sciences, 1 Clariant, 22 Corel Pharma Chem, 7 DFE Pharma, 2 Finar, 13 Gangwal Chemicals, 12 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 39 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 19 Microlex e.U, 2 Nanjing Bold Chemical, 2 Nomisma Healthcare, 4 Novo Excipients, 4 Pharmatrans-Sanaq, 9 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 40 Roquette, 14 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 3 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 3 The Dow Chemical Company, 3 Ulanqab Kema New Material, 3 Valens Pharmachem, 5 Vasa Pharmachem, 1 Vertellus, 2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

112 Fillers, Diluents & Binders, 76 Coating Systems & Additives, 55 Controlled & Modified Release, 52 Direct Compression, 43 Disintegrants & Superdisintegrants, 43 Thickeners and Stabilizers, 39 Taste Masking, 36 Granulation, 34 Solubilizers, 30 Film Formers & Plasticizers, 29 Parenteral, 26 Lubricants & Glidants, 23 Co-Processed Excipients, 22 Topical, 22 Chewable & Orodispersible Aids, 9 Empty Capsules, 9 API Stability Enhancers, 9 Emulsifying Agents, 7 Rheology Modifiers, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 1 Soft Gelatin

DIGITAL CONTENT

5 DATA COMPILATION #PharmaFlow, 289 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

4 US Medicaid Prescriptions, 273 Finished Drug Prices, 18 Annual Reports

MARKET PLACE

10 APIs, 9 FDF Dossiers

PATENTS & EXCLUSIVITIES

223 US Patents, 4 US Exclusivities, 54 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 5 USP, 7 Others

$ Xls

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USFDA APPLICATION NUMBER - 200535 / DOSAGE - SOLUTION;ORAL - 100MG/5ML

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OXYCODONE HYDROCHLORIDE(UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570)	OXYCODONE HYDROCHLORIDE	20mg in 1

Inactive Ingredients

Ingredient Name	Lannett Company, Inc.	ANI Pharmaceuticals, Inc.	Lupin Pharmaceuticals, Inc.	Major Pharmaceuticals	Novel Laboratories, Inc.	Roxane Laboratories, Inc.	VistaPharm, Inc.	West-Ward Pharmaceuticals Corp.	KVK-Tech, Inc.	Safecor Health, LLC
ACESULFAME POTASSIUM(23OV73Q5G9)
ANHYDROUS CITRIC ACID(XF417D3PSL)
BERRY(FV3431923Z)
CITRIC ACID MONOHYDRATE(2968PHW8QP)
D&C YELLOW NO. 10(35SW5USQ3G)
EDETATE DISODIUM(7FLD91C86K)
FD&C RED NO. 40(WZB9127XOA)
FD&C YELLOW NO. 6(H77VEI93A8)
GLYCERIN(PDC6A3C0OX)
HYDROCHLORIC ACID(QTT17582CB)
MALTITOL(D65DG142WK)
PROPYLENE GLYCOL(6DC9Q167V3)
SACCHARIN SODIUM(SB8ZUX40TY)
SODIUM BENZOATE(OJ245FE5EU)
SODIUM CITRATE(1Q73Q2JULR)
SODIUM GLUCONATE(R6Q3791S76)
SODIUM HYDROXIDE(55X04QC32I)
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE(94255I6E2T)
SORBITOL(506T60A25R)
SUCRALOSE(96K6UQ3ZD4)
TRISODIUM CITRATE DIHYDRATE(B22547B95K)
WATER(059QF0KO0R)

Drug Product Composition: Oxycodone Hydrochloride