Duloxetine Hydrochloride

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ACTIVE PHARMA INGREDIENTS

107 API Suppliers, 45 USDMF, 29 CEP/COS, 13 JDMF, 18 EU WC, 26 KDMF, 18 NDC API, 58 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

INTERMEDIATES

30 Intermediates Suppliers

30 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

587 FDF Dossiers, 98 FDA Orange Book, 282 Europe, 44 Canada, 14 Australia, 30 South Africa, 119 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE, DELAYED REL PELLETS;ORAL - EQ 20MG BASE, CAPSULE, DELAYED REL PELLETS;ORAL - EQ 30MG BASE, CAPSULE, DELAYED REL PELLETS;ORAL - EQ 60MG BASE

RELATED EXCIPIENT COMPANIES

2 Evonik, 1 Rochem International Inc, 15 SPI Pharma, 2 Seqens, 15 DKSH, 2 Jai Radhe Sales, 7 Faran Shimi Pharmaceutical, 8 Boai NKY Pharmaceuticals Ltd, 10 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 6 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 35 BASF, 1 Clariant, 13 Corel Pharma Chem, 3 DFE Pharma, 2 Finar, 14 Gangwal Chemicals, 11 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 31 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 2 Nanjing Bold Chemical, 2 Nomisma Healthcare, 4 Novo Excipients, 2 Pharmatrans-Sanaq, 7 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 11 Roquette, 14 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 6 Sigachi Industries, 4 The Dow Chemical Company, 2 Ulanqab Kema New Material, 2 Valens Pharmachem, 2 Vasa Pharmachem, 2 Vertellus

EXCIPIENTS BY APPLICATIONS

86 Fillers, Diluents & Binders, 73 Coating Systems & Additives, 40 Controlled & Modified Release, 39 Direct Compression, 34 Solubilizers, 31 Disintegrants & Superdisintegrants, 25 Granulation, 25 Thickeners and Stabilizers, 20 Parenteral, 20 Taste Masking, 20 Topical, 17 Lubricants & Glidants, 17 Co-Processed Excipients, 17 Chewable & Orodispersible Aids, 16 Film Formers & Plasticizers, 9 Empty Capsules, 8 API Stability Enhancers, 8 Emulsifying Agents, 5 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Rheology Modifiers

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 50 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 216 Finished Drug Prices, 14 Annual Reports

MARKET PLACE

23 APIs, 7 FDF Dossiers

PATENTS & EXCLUSIVITIES

16 US Patents, 6 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 3 USP, 10 Others

ANALYTICAL

2 BioAnalytical Methods, 2 Analytical Methods

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USFDA APPLICATION NUMBER - 21427 / DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - EQ 60MG BASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Duloxetine hydrochloride (UNII: 9044SC542W) (Duloxetine - UNII:O5TNM5N07U)	Duloxetine	30mg \| 60mg

Inactive Ingredients

Ingredient Name	A-S Medication Solutions	BluePoint Laboratories	Bryant Ranch Prepack	Cadila Healthcare Limited	Cipla USA Inc.	Heritage Pharmaceuticals Inc.	Inventia Healthcare Private Limited	Preferred Pharmaceuticals Inc.	REMEDYREPACK INC.	Aurobindo Pharma Limited	Avera McKennan Hospital	AvPAK	Cardinal Health	Dr. Reddy's Laboratories Limited	KAISER FOUNDATION HOSPITALS	Lake Erie Medical DBA Quality Care Products LLC	LUPIN PHARMA	Lupin Pharmaceuticals, Inc.	Major Pharmaceuticals	Mylan Institutional Inc.	NCS HealthCare of KY, Inc dba Vangard Labs	Prasco Laboratories	Preferred Pharmaceuticals, Inc.	Quality Care Products, LLC	Trigen Laboratories, LLC	QPharma Inc	Teva Pharmaceuticals USA, Inc.	NCS HealthCare of KY, LLC dba Vangard Labs	Torrent Pharmaceuticals Limited	TYA Pharmaceuticals	Unit Dose Services	Yaopharma Co., Ltd.	Clinical Solutions Wholesale	Lake Erie Medical Surgical & Supply DBA Quality Care Products LLC	PD-Rx Pharmaceuticals, Inc.	Proficient Rx LP	St Marys Medical Park Pharmacy	REMEDYREPACK INC.	Yaopharma Co., L
ALCOHOL(3K9958V90M)
AMMONIA(5138Q19F1X)
BUTYL ALCOHOL(8PJ61P6TS3)
CROSCARMELLOSE SODIUM(M28OL1HH48)
CROSPOVIDONE (120 .MU.M)(68401960MK)
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)
CROSPOVIDONE(2S7830E561)
CROSPOVIDONE(68401960MK)
D&C YELLOW NO. 10(35SW5USQ3G)
DIBUTYL SEBACATE(4W5IH7FLNY)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C BLUE NO. 2(L06K8R7DQK)
FD&C GREEN NO. 3(3P3ONR6O1S)
FD&C RED NO. 3(PN2ZH5LOQY)
FD&C RED NO. 40(WZB9127XOA)
FD&C YELLOW NO. 6(H77VEI93A8)
FERRIC OXIDE YELLOW(EX438O2MRT)
FERROSOFERRIC OXIDE(XM0M87F357)
GELATIN(2G86QN327L)
GELATIN, UNSPECIFIED(2G86QN327L)
Glycine(TE7660XO1C)
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE (TYPE E)(66O7AQV0RT)
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE(RFW2ET671P)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)
HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W)
HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82)
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)
HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MM2/S)(24P2YXD2PW)
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)(87Y6436BKR)
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)(G4U024CQK6)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
ISOPROPYL ALCOHOL(ND2M416302)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(NX76LV5T8J)
METHYLCELLULOSE (15 CPS)(NPU9M2E6L8)
METHYLCELLULOSE (15 MPA.S)(NPU9M2E6L8)
METHYLENE CHLORIDE(588X2YUY0A)
POLOXAMER 407(TUF2IVW3M2)
POLYETHYLENE GLYCOL 400(B697894SGQ)
POLYSORBATE 80(6OZP39ZG8H)
Polyvinyl Acetate Phthalate(58QVG85GW3)
POTASSIUM HYDROXIDE(WZH3C48M4T)
POVIDONE K30(U725QWY32X)
POVIDONE(FZ989GH94E)
POVIDONE, UNSPECIFIED(FZ989GH94E)
POVIDONES(FZ989GH94E)
PROPYLENE GLYCOL 1-(2-METHYLBUTYRATE)(9Q5W5G6461)
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM HYDROXIDE(55X04QC32I)
Sodium lauryl sulfate(368GB5141J)
STARCH, CORN(O8232NY3SJ)
STARCH, PREGELATINIZED CORN(O8232NY3SJ)
SUCROSE(C151H8M554)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIETHYL CITRATE(8Z96QXD6UM)
WATER(059QF0KO0R)

Drug Product Composition: Duloxetine Hydrochloride