Sertraline Hydrochloride

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ACTIVE PHARMA INGREDIENTS

65 API Suppliers, 25 USDMF, 25 CEP/COS, 7 JDMF, 23 EU WC, 14 KDMF, 20 NDC API, 30 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

6 Drugs in Development

6 Drugs in Development

INTERMEDIATES

16 Intermediates Suppliers

16 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

517 FDF Dossiers, 96 FDA Orange Book, 255 Europe, 54 Canada, 34 Australia, 25 South Africa, 53 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 100MG BASE, TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 25MG BASE, TABLET;ORAL - EQ 50MG BASE

RELATED EXCIPIENT COMPANIES

4 SPI Pharma, 2 Seqens, 3 DKSH, 2 Jai Radhe Sales, 5 Faran Shimi Pharmaceutical, 6 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 7 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 23 BASF, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 12 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 7 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 31 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 12 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 4 Novo Excipients, 3 Pharmatrans-Sanaq, 6 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 13 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 12 Sigachi Industries, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

77 Fillers, Diluents & Binders, 52 Coating Systems & Additives, 37 Direct Compression, 32 Controlled & Modified Release, 31 Disintegrants & Superdisintegrants, 27 Solubilizers, 23 Thickeners and Stabilizers, 22 Granulation, 21 Film Formers & Plasticizers, 18 Topical, 17 Parenteral, 17 Lubricants & Glidants, 17 Co-Processed Excipients, 8 Taste Masking, 8 Emulsifying Agents, 7 API Stability Enhancers, 6 Chewable & Orodispersible Aids, 5 Rheology Modifiers, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Coloring Agents, 3 Surfactant & Foaming Agents

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 28 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 217 Finished Drug Prices, 9 Annual Reports

MARKET PLACE

17 APIs, 6 FDF Dossiers

PATENTS & EXCLUSIVITIES

5 Health Canada Patents

5 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 3 USP, 11 Others

ANALYTICAL

1 Analytical Methods

1 Analytical Methods

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USFDA APPLICATION NUMBER - 19839 / DOSAGE - TABLET;ORAL - EQ 100MG BASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
sertraline hydrochloride(UNII: UTI8907Y6X) (sertraline - UNII:QUC7NX6WMB)	sertraline hydrochloride	100mg

Inactive Ingredients

Ingredient Name	REMEDYREPACK INC.	Aphena Pharma Solutions - Tennessee, LLC	Bryant Ranch Prepack	Cardinal Health	KAISER FOUNDATION HOSPITALS	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	PD-Rx Pharmaceuticals, Inc.	Zydus Pharmaceuticals (USA) Inc.	A-S Medication Solutions	Actavis Pharma, Inc.	Clinical Solutions Wholesale	Lake Erie Medical DBA Quality Care Products LLC	Legacy Pharmaceutical Packaging, LLC	Mylan Institutional Inc.	Mylan Pharmaceuticals Inc.	NuCare Pharmaceuticals, Inc.	Preferred Pharmaceuticals Inc.	Preferred Pharmaceuticals, Inc.	QPharma Inc	State of Florida DOH Central Pharmacy	ACI Healthcare USA, Inc.	Granules Pharmaceuticals Inc.	NCS HealthCare of KY, LLC dba Vangard Labs	American Health Packaging	Hikma Pharmaceuticals USA Inc.	International Laboratories, LLC	Major Pharmaceuticals	McKesson Contract Packaging	NCS HealthCare of KY, Inc dba Vangard Labs	Aphena Pharma Solutions - Tennessee, Inc.	Apotex Corp	Cipla USA Inc.	Clinical Solutions Wholesale, LLC	Hikma Pharmaceutical	McKesson Packaging Services Business Unit of McKesson Corporation	St Marys Medical Park Pharmacy	St. Mary's Medical Park Pharmacy	St. Maryâ€™s Medical Park Pharmacy	Zydus Pharmaceutica	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	Ascent Pharmaceuticals, Inc	Ascent Pharmaceuticals, Inc.	Camber Pharmaceuticals, Inc.	XLCare Pharmaceuticals, Inc.	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	Quallent Pharmaceuticals Health LLC	St. Mary's	NuCare Pharma	NCS HealthCare of KY, In	St Marys Medic	St Marys Medi	NCS He
ALCOHOL, X-RAY EXPOSED (1000 RAD)(6PRJ93602P)
aluminum oxide(LMI26O6933)
AMMONIUM LAURETH-5 SULFATE(43ZIH89I48)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(L11K75P92J)
ANHYDROUS LACTOSE(3SY5LH9PMK)
BUTYLATED HYDROXYTOLUENE(1P9D0Z171K)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS(L11K75P92J)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE(O7TSZ97GEP)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
COPOVIDONE K25-31(D9C330MD8B)
COPOVIDONE(D9C330MD8B)
CROSCARMELLOSE SODIUM(M28OL1HH48)
D&C YELLOW NO. 10 ALUMINUM LAKE(CQ3XH3DET6)
D&C YELLOW NO. 10(35SW5USQ3G)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(O7TSZ97GEP)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C BLUE NO. 1--ALUMINUM LAKE(J9EQA3S2JM)
FD&C BLUE NO. 2 ALUMINUM LAKE(4AQJ3LG584)
FD&C BLUE NO. 2(L06K8R7DQK)
FD&C RED NO. 40(WZB9127XOA)
FD&C YELLOW NO. 6(H77VEI93A8)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
FERROSOFERRIC OXIDE(XM0M87F357)
GLYCERIN(PDC6A3C0OX)
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UKE75GEA7F)
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE (TYPE L)(UKE75GEA7F)
HYDROXYPROPYL CELLULOSE(RFW2ET671P)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(2165RE0K14)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)
HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W)
HYPROMELLOSE 2910 (3 CPS)(0VUT3PMY82)
HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82)
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)
HYPROMELLOSE 2910 (6 CPS)(0WZ8WG20P6)
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)
hypromellose(3NXW29V3WO)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
INDIGOTINDISULFONATE SODIUM(D3741U8K7L)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
magnesium stearate(70097M6I30)
MENTHOL 1-PROPYLENE GLYCOL CARBONATE, (-)-(2WL8FX4EEZ)
METHYLCELLULOSE (15 CPS)(NPU9M2E6L8)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYDEXTROSE(VH2XOU12IE)
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)
POLYETHYLENE GLYCOL 400(B697894SGQ)
POLYETHYLENE GLYCOL 6000(30IQX730WE)
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)
polyethylene glycol(3WJQ0SDW1A)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
POLYSORBATE 80(6OZP39ZG8H)
POLYVINYL ALCOHOL(532B59J990)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
POVIDONE K30(U725QWY32X)
POVIDONE(FZ989GH94E)
POVIDONE, UNSPECIFIED(FZ989GH94E)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
SODIUM STARCH GLYCOLATE TYPE A(H8AV0SQX4D)
STARCH, CORN(O8232NY3SJ)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)

Drug Product Composition: Sertraline Hydrochloride