ROXICET-1

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ACTIVE PHARMA INGREDIENTS

37 API Suppliers, 13 USDMF, 11 CEP/COS, 1 JDMF, 1 EU WC, 7 KDMF, 16 NDC API, 15 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

9 Drugs in Development

9 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

1011 FDF Dossiers, 290 FDA Orange Book, 554 Europe, 49 Canada, 52 Australia, 21 South Africa, 45 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

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SOLUTION;ORAL - 5MG/5ML, SOLUTION;ORAL - 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 5MG, TABLET;ORAL - 7.5MG, TABLET, EXTENDED RELEASE;ORAL - 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 13.5MG, CAPSULE, EXTENDED RELEASE;ORAL - 18MG, CAPSULE, EXTENDED RELEASE;ORAL - 27MG,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RELEASE;ORAL - 80MG, TABLET;ORAL - 325MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 15 Evonik, 7 Rochem International Inc, 23 SPI Pharma, 21 DKSH, 2 Pharm-RX Chemical, 8 Boai NKY Pharmaceuticals Ltd, 9 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 3 Pfanstiehl, 8 Kirsch Pharma, 4 ACG Worldwide, 14 Actylis, 1 Aeon Procare, 3 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 3 Ashland, 38 BASF, 1 Bioplus Life Sciences, 3 CD Formulation, 1 Clariant, 22 Corel Pharma Chem, 7 DFE Pharma, 1 Esteem Industries, 2 Finar, 13 Gangwal Chemicals, 10 Ideal Cures, 5 Ingredion Pharma Solutions, 26 Kerry, 3 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 19 Microlex e.U, 2 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 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, 11 Sigachi Industries, 5 Silverline Chemicals, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 3 Valens Pharmachem, 5 Vasa Pharmachem, 1 Vertellus, 2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

93 Fillers, Diluents & Binders, 80 Coating Systems & Additives, 56 Controlled & Modified Release, 51 Thickeners and Stabilizers, 46 Direct Compression, 45 Disintegrants & Superdisintegrants, 45 Taste Masking, 41 Granulation, 35 Solubilizers, 33 Film Formers & Plasticizers, 32 Parenteral, 25 Chewable & Orodispersible Aids, 25 Lubricants & Glidants, 25 Topical, 17 Co-Processed Excipients, 11 Rheology Modifiers, 10 Emulsifying Agents, 9 Empty Capsules, 8 API Stability Enhancers, 6 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

DIGITAL CONTENT

295 News #PharmaBuzz

295 News #PharmaBuzz

GLOBAL SALES INFORMATION

59 US Medicaid Prescriptions, 176 Regulatory FDF Prices, 20 Annual Reports

MARKET PLACE

13 APIs, 9 FDF Dossiers

PATENTS & EXCLUSIVITIES

237 US Patents, 71 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 7 Others

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USFDA APPLICATION NUMBER - 202080 / DOSAGE - TABLET;ORAL - 7.5MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OXYCODONE HYDROCHLORIDE(UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570)	OXYCODONE HYDROCHLORIDE	5mg \| 7.5mg

Setid Dd9f9d6d 9a59 4f74 8fe7 685e0c3c5fd4 Applno 202080 Form Tablet Oral Dosage 7 5mg - Drug Product Composition: ROXICET-1

ROXICET-1

ROXICET-1

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Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

37 API Suppliers

13 USDMF

11 CEP/COS

1 JDMF

1 EU WC

7 KDMF

16 NDC API

15 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

9 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

1011 FDF Dossiers

290 FDA Orange Book

554 Europe

49 Canada

52 Australia

21 South Africa

45 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 5MG

SOLUTION;ORAL - 100MG/5ML

SOLUTION;ORAL - 5MG/5ML

SOLUTION;ORAL - 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 EUROAPI

15 Evonik

7 Rochem International Inc

23 SPI Pharma

21 DKSH

2 Pharm-RX Chemical

8 Boai NKY Pharmaceuticals Ltd

9 Gangwal Healthcare

7 Nanjing Well Pharmaceutical

3 Pfanstiehl

8 Kirsch Pharma

4 ACG Worldwide

14 Actylis

1 Aeon Procare

3 Alcedo Pharmachem

9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

3 Ashland

38 BASF

1 Bioplus Life Sciences

3 CD Formulation

1 Clariant

22 Corel Pharma Chem

7 DFE Pharma

1 Esteem Industries

2 Finar

13 Gangwal Chemicals

10 Ideal Cures

5 Ingredion Pharma Solutions

26 Kerry

SOLUTION;ORAL - 5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 325MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 325MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons