Acetaminophen

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ACTIVE PHARMA INGREDIENTS

257 API Suppliers, 80 USDMF, 20 CEP/COS, 16 JDMF, 9 EU WC, 108 KDMF, 107 NDC API, 34 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

158 Drugs in Development

158 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

3067 FDF Dossiers, 734 FDA Orange Book, 884 Europe, 296 Canada, 72 Australia, 410 South Africa, 671 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SUPPOSITORY;RECTAL - 120MG, SUPPOSITORY;RECTAL - 325MG, SUPPOSITORY;RECTAL - 650MG, SUPPOSITORY;RECTAL - 80MG, CAPSULE;ORAL - 325MG;50MG;40MG;30MG, TABLET, EXTENDED RELEASE;ORAL - 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 250MG;250MG;65MG, TABLET;ORAL - 325MG;37.5MG, SOLUTION;INTRAVENOUS - 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 300MG;15MG, TABLET;ORAL - 300MG;30MG, TABLET;ORAL - 300MG;60MG, TABLET;ORAL - 325MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 325MG;50MG;40MG, TABLET;ORAL - 300MG;60MG

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 2 Minakem, 1 Evonik, 13 Rochem International Inc, 32 SPI Pharma, 37 DKSH, 2 Pharm-RX Chemical, 14 Boai NKY Pharmaceuticals Ltd, 11 Gangwal Healthcare, 21 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Pfanstiehl, 1 Capital Farma, 14 Kirsch Pharma, 4 ACG Worldwide, 19 Actylis, 3 Aeon Procare, 2 Alcedo Pharmachem, 11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 4 Ashland, 1 Avesta Pharma, 44 BASF, 8 Beneo, 2 Bioplus Life Sciences, 6 CD Formulation, 6 Clariant, 12 Corel Pharma Chem, 7 DFE Pharma, 2 Esteem Industries, 4 Finar, 17 Gangwal Chemicals, 2 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures, 5 Ingredion Pharma Solutions, 26 Kerry, 4 Keval Exports, 5 Kima Chemical, 6 Lonza Capsugel, 27 Microlex e.U, 2 Nanjing Bold Chemical, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 5 Novo Excipients, 5 Pharmatrans-Sanaq, 12 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 56 Roquette, 22 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, 1 Symrise, 4 The Dow Chemical Company, 3 Ulanqab Kema New Material, 1 Valens Pharmachem, 5 Vasa Pharmachem, 3 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

127 Fillers, Diluents & Binders, 92 Thickeners and Stabilizers, 73 Solubilizers, 64 Coating Systems & Additives, 60 Taste Masking, 59 Topical, 55 Direct Compression, 54 Parenteral, 50 Disintegrants & Superdisintegrants, 45 Granulation, 39 Lubricants & Glidants, 38 Film Formers & Plasticizers, 35 Controlled & Modified Release, 28 Emulsifying Agents, 28 Chewable & Orodispersible Aids, 24 Rheology Modifiers, 18 Co-Processed Excipients, 17 Surfactant & Foaming Agents, 12 API Stability Enhancers, 9 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

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GLOBAL SALES INFORMATION

94 US Medicaid Prescriptions, 144 Regulatory FDF Prices, 21 Annual Reports

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191 APIs, 95 FDF Dossiers

PATENTS & EXCLUSIVITIES

41 US Patents, 2 US Exclusivities, 7 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 EDQM, 1 JP, 36 Others

ANALYTICAL

2 BioAnalytical Methods, 8 Analytical Methods

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USFDA APPLICATION NUMBER - 18337 / DOSAGE - SUPPOSITORY;RECTAL - 325MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN(UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650mg

Inactive Ingredients

Ingredient Name	Cosette Pharmaceuticals, Inc.	Actavis Mid Atlantic LLC	Cardinal Health	Preferred Pharmaceuticals Inc.	REMEDYREPACK INC.
BUTYLATED HYDROXYANISOLE(REK4960K2U)
BUTYLATED HYDROXYTOLUENE(1P9D0Z171K)
GLYCERYL MONOSTEARATE(230OU9XXE4)
Hydrogenated Coconut Oil(JY81OXM1OM)
HYDROGENATED PALM KERNEL OIL(FM8D1RE2VP)
PEG-100 STEARATE(YD01N1999R)
PEG-8 STEARATE(2P9L47VI5E)
POLYSORBATE 80(6OZP39ZG8H)
SORBITAN MONOOLEATE(06XEA2VD56)

Setid F90b4520 8e08 4bbb Ada4 F494cefcd311 Applno 18337 Form Suppository Rectal Dosage 325mg - Drug Product Composition: Acetaminophen

Acetaminophen

Acetaminophen

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

257 API Suppliers

80 USDMF

20 CEP/COS

16 JDMF

9 EU WC

108 KDMF

107 NDC API

34 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

158 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

3067 FDF Dossiers

734 FDA Orange Book

884 Europe

296 Canada

72 Australia

410 South Africa

671 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SUPPOSITORY;RECTAL - 120MG

SUPPOSITORY;RECTAL - 325MG

SUPPOSITORY;RECTAL - 650MG

SUPPOSITORY;RECTAL - 80MG

CAPSULE;ORAL - 325MG;50MG;40MG;30MG

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

TABLET;ORAL - 250MG;250MG;65MG

TABLET;ORAL - 325MG;37.5MG

SOLUTION;INTRAVENOUS - 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 300MG;15MG

TABLET;ORAL - 300MG;30MG

TABLET;ORAL - 300MG;60MG

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

TABLET;ORAL - 325MG;50MG;40MG

TABLET;ORAL - 300MG;60MG

RELATED EXCIPIENT COMPANIES

2 EUROAPI

2 Minakem

1 Evonik

13 Rochem International Inc

32 SPI Pharma

37 DKSH

2 Pharm-RX Chemical

14 Boai NKY Pharmaceuticals Ltd

11 Gangwal Healthcare

21 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

2 Pfanstiehl

1 Capital Farma

14 Kirsch Pharma

4 ACG Worldwide

19 Actylis

3 Aeon Procare

2 Alcedo Pharmachem

11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

4 Ashland

1 Avesta Pharma

44 BASF

8 Beneo

2 Bioplus Life Sciences

6 CD Formulation

6 Clariant

12 Corel Pharma Chem

7 DFE Pharma

2 Esteem Industries

4 Finar

17 Gangwal Chemicals

2 Huzhou Sunflower Pharmaceutical

5 Ideal Cures

5 Ingredion Pharma Solutions

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

SOLUTION;INTRAVENOUS - 1GM/100ML (10MG/ML) 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