Paroxetine Hydrochloride Hemihydrate

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

75 API Suppliers, 27 USDMF, 15 CEP/COS, 9 JDMF, 12 EU WC, 13 KDMF, 14 NDC API, 26 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

10 Drugs in Development

10 Drugs in Development

INTERMEDIATES

12 Intermediate Suppliers

12 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

431 FDF Dossiers, 96 FDA Orange Book, 215 Europe, 57 Canada, 16 Australia, 22 South Africa, 25 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 10MG BASE, TABLET;ORAL - EQ 20MG BASE, TABLET;ORAL - EQ 30MG BASE, TABLET;ORAL - EQ 40MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 12.5MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 25MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 37.5MG BASE

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 2 Evonik, 1 Rochem International Inc, 6 SPI Pharma, 14 DKSH, 4 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 9 Nanjing Well Pharmaceutical, 2 Kirsch Pharma, 1 ACG Worldwide, 7 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 28 BASF, 1 Clariant, 14 Corel Pharma Chem, 6 DFE Pharma, 1 Doshion Polyscience, 1 Esteem Industries, 2 Finar, 12 Gangwal Chemicals, 9 Ideal Cures, 3 Ingredion Pharma Solutions, 23 Kerry, 2 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 12 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 6 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 26 Roquette, 14 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 3 Silverline Chemicals, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 3 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

64 Fillers, Diluents & Binders, 62 Coating Systems & Additives, 33 Controlled & Modified Release, 31 Direct Compression, 30 Solubilizers, 28 Granulation, 25 Thickeners and Stabilizers, 25 Film Formers & Plasticizers, 21 Disintegrants & Superdisintegrants, 20 Topical, 20 Parenteral, 19 Taste Masking, 17 Lubricants & Glidants, 14 Co-Processed Excipients, 9 Emulsifying Agents, 9 Chewable & Orodispersible Aids, 7 Rheology Modifiers, 6 Surfactant & Foaming Agents, 6 API Stability Enhancers, 5 Coloring Agents, 5 Empty Capsules, 4 Vegetarian Capsules, 1 Soft Gelatin

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 47 News #PharmaBuzz

GLOBAL SALES INFORMATION

19 US Medicaid Prescriptions, 92 Regulatory FDF Prices, 8 Annual Reports

MARKET PLACE

13 APIs, 4 FDF Dossiers

PATENTS & EXCLUSIVITIES

55 Health Canada Patents

55 Health Canada Patents

REF. STANDARDS & IMPURITIES

8 EDQM, 1 USP, 4 JP, 15 Others

ANALYTICAL

4 BioAnalytical Methods, 1 Analytical Methods

$ Xls

Filters

Xls

USFDA APPLICATION NUMBER - 20936 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 25MG BASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PAROXETINE HYDROCHLORIDE HEMIHYDRATE(UNII: X2ELS050D8) (PAROXETINE - UNII:41VRH5220H)	PAROXETINE	25mg

Inactive Ingredients

Ingredient Name	Lupin Pharmaceuticals, Inc.	Apotex Corp	Mylan Pharmaceuticals Inc.	AvKARE, Inc.	Bryant Ranch Prepack	REMEDYREPACK INC.	GlaxoSmithKline Inc
ALUMINUM OXIDE(LMI26O6933)
CASTOR OIL(D5340Y2I9G)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
D&C RED NO. 30(2S42T2808B)
D&C YELLOW NO. 10(35SW5USQ3G)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C BLUE NO. 2 (L06K8R7DQK)
FD&C BLUE NO. 2(L06K8R7DQK)
FD&C YELLOW NO. 5(I753WB2F1M)
FD&C YELLOW NO. 6 (H77VEI93A8)
FD&C YELLOW NO. 6(H77VEI93A8)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW (EX438O2MRT)
FERRIC OXIDE YELLOW (EX438O2MRT)
FERRIC OXIDE YELLOW(EX438O2MRT)
FERROSOFERRIC OXIDE(XM0M87F357)
GLYCERYL DIBEHENATE(R8WTH25YS2)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)
HYPROMELLOSE 2208 (100 MPA.S)(B1QE5P712K)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
LECITHIN, SOYBEAN(1DI56QDM62)
MAGNESIUM STEARATE(70097M6I30)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S)(T967IEU43C)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(NX76LV5T8J)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
PIGMENT RED 48(07XHK4SAV6)
POLYDEXTROSE(VH2XOU12IE)
POLYETHYLENE GLYCOL 10000(H57W405143)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
POLYSORBATE 80(6OZP39ZG8H)
POLYVINYL ALCOHOL (100000 MW)(949E52Z6MY)
POVIDONE K30(U725QWY32X)
POVIDONE(FZ989GH94E)
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM ALGINATE(C269C4G2ZQ)
SODIUM HYDROXIDE(55X04QC32I)
SODIUM LAURYL SULFATE(368GB5141J)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)
TRIETHYL CITRATE(8Z96QXD6UM)

Setid Cd5fcd4b 979a 4879 9fe3 A3c8964baaa5 Applno 20936 Form Tablet Extended Release Oral Dosage Eq 25mg Base - Drug Product Composition: Paroxetine Hydrochloride Hemihydrate