Naproxen

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ACTIVE PHARMA INGREDIENTS

40 API Suppliers, 23 USDMF, 11 CEP/COS, 1 JDMF, 3 EU WC, 37 KDMF, 12 NDC API, 1 VMF, 17 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

INTERMEDIATES

4 Intermediates Suppliers

4 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

327 FDF Dossiers, 115 FDA Orange Book, 96 Europe, 26 Canada, 23 Australia, 25 South Africa, 42 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 250MG, TABLET;ORAL - 375MG, TABLET;ORAL - 500MG, SUSPENSION;ORAL - 25MG/ML, TABLET, DELAYED RELEASE;ORAL - 375MG, TABLET, DELAYED RELEASE;ORAL - 500MG, TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Evonik, 1 Rochem International Inc, 6 SPI Pharma, 2 Seqens, 4 DKSH, 2 Jai Radhe Sales, 6 Faran Shimi Pharmaceutical, 11 Boai NKY Pharmaceuticals Ltd, 14 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 8 Actylis, 2 Aeon Procare, 2 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 33 BASF, 1 Clariant, 14 Corel Pharma Chem, 6 DFE Pharma, 3 Doshion Polyscience, 2 Finar, 12 Gangwal Chemicals, 13 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 32 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 12 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 6 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 27 Roquette, 14 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 2 The Dow Chemical Company, 4 Ulanqab Kema New Material, 2 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

77 Fillers, Diluents & Binders, 70 Coating Systems & Additives, 41 Controlled & Modified Release, 41 Disintegrants & Superdisintegrants, 40 Direct Compression, 33 Solubilizers, 30 Thickeners and Stabilizers, 27 Granulation, 23 Film Formers & Plasticizers, 22 Co-Processed Excipients, 20 Taste Masking, 18 Lubricants & Glidants, 17 Parenteral, 16 Topical, 11 Chewable & Orodispersible Aids, 8 Emulsifying Agents, 6 API Stability Enhancers, 5 Empty Capsules, 5 Surfactant & Foaming Agents, 5 Coloring Agents, 5 Rheology Modifiers, 4 Vegetarian Capsules, 1 Soft Gelatin

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 35 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 83 Finished Drug Prices, 1 Annual Reports

MARKET PLACE

30 APIs, 3 FDF Dossiers

REF. STANDARDS & IMPURITIES

3 EDQM, 5 USP, 14 Others

ANALYTICAL

3 BioAnalytical Methods

3 BioAnalytical Methods

$ Xls

Filters

Xls

USFDA APPLICATION NUMBER - 20067 / DOSAGE - TABLET, DELAYED RELEASE;ORAL - 375MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
naproxen sodium(UNII: 9TN87S3A3C) (naproxen - UNII:57Y76R9ATQ)	naproxen sodium	550mg
naproxen(UNII: 57Y76R9ATQ) (naproxen - UNII:57Y76R9ATQ)	naproxen	500mg \| 375mg \| 500mg

Inactive Ingredients

Ingredient Name	Lake Erie Medical DBA Quality Care Products LLC	A-S Medication Solutions	AvKARE, Inc.	Bryant Ranch Prepack	Cipla USA Inc.	Genentech, Inc.	medsource pharmaceuticals	PD-Rx Pharmaceuticals, Inc.	Preferred Pharmaceuticals Inc.	REMEDYREPACK INC.	TruPharma LLC
ALUMINUM OXIDE(LMI26O6933)
CROSCARMELLOSE SODIUM(M28OL1HH48)
FD&C BLUE NO. 2(L06K8R7DQK)
ferric oxide red(1K09F3G675)
FERROSOFERRIC OXIDE(XM0M87F357)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
INDIGOTINDISULFONATE SODIUM(D3741U8K7L)
magnesium stearate(70097M6I30)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)
methacrylic acid - methyl methacrylate copolymer (1:1)(74G4R6TH13)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(NX76LV5T8J)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
polyethylene glycol 8000(Q662QK8M3B)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POVIDONE K90(RDH86HJV5Z)
POVIDONE(FZ989GH94E)
POVIDONE, UNSPECIFIED(FZ989GH94E)
POVIDONES(FZ989GH94E)
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O)
SILICON DIOXIDE(ETJ7Z6XBU4)
sodium hydroxide(55X04QC32I)
STARCH, CORN(O8232NY3SJ)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIETHYL CITRATE(8Z96QXD6UM)
water(059QF0KO0R)

Drug Product Composition: Naproxen

Naproxen

Naproxen

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

40 API Suppliers

23 USDMF

11 CEP/COS

1 JDMF

3 EU WC

37 KDMF

12 NDC API

1 VMF

17 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

3 Drugs in Development

INTERMEDIATES

4 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

327 FDF Dossiers

115 FDA Orange Book

96 Europe

26 Canada

23 Australia

25 South Africa

42 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 250MG

TABLET;ORAL - 375MG

TABLET;ORAL - 500MG

SUSPENSION;ORAL - 25MG/ML

TABLET, DELAYED RELEASE;ORAL - 375MG

TABLET, DELAYED RELEASE;ORAL - 500MG

TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Evonik

1 Rochem International Inc

6 SPI Pharma

2 Seqens

4 DKSH

2 Jai Radhe Sales

6 Faran Shimi Pharmaceutical

11 Boai NKY Pharmaceuticals Ltd

14 Gangwal Healthcare

6 Nanjing Well Pharmaceutical

1 Pfanstiehl

1 ACG Worldwide

8 Actylis

2 Aeon Procare

2 Alcedo Pharmachem

10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

33 BASF

1 Clariant

14 Corel Pharma Chem

6 DFE Pharma

3 Doshion Polyscience

2 Finar

12 Gangwal Chemicals

13 Ideal Cures Pvt Ltd

4 Ingredion Pharma Solutions

32 Kerry

3 Kima Chemical

6 Lonza Capsugel

12 Microlex e.U

1 Nanjing Bold Chemical

2 Nomisma Healthcare

3 Novo Excipients

4 Pharmatrans-Sanaq

6 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

27 Roquette

14 Seppic

6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;375MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons