Paliperidone

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ACTIVE PHARMA INGREDIENTS

41 API Suppliers, 26 USDMF, 11 EU WC, 3 KDMF, 13 NDC API, 21 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

INTERMEDIATES

10 API Suppliers

10 API Suppliers

FINISHED DOSAGE FORMULATIONS

166 FDF Dossiers, 45 FDA Orange Book, 63 Europe, 3 Canada, 14 Australia, 7 South Africa, 34 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 3MG, TABLET, EXTENDED RELEASE;ORAL - 6MG, TABLET, EXTENDED RELEASE;ORAL - 9MG

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 SPI Pharma, 2 Seqens, 11 DKSH, 1 Jai Radhe Sales, 1 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 6 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 22 BASF, 10 Corel Pharma Chem, 2 DFE Pharma, 2 Finar, 6 Gangwal Chemicals, 6 Ideal Cures Pvt Ltd, 28 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 6 Microlex e.U, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 3 Novo Excipients, 2 Pharmatrans-Sanaq, 2 Pluviaendo, 1 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 4 Roquette, 6 Seppic, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 4 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem

EXCIPIENTS BY APPLICATIONS

52 Coating Systems & Additives, 42 Fillers, Diluents & Binders, 28 Controlled & Modified Release, 17 Direct Compression, 15 Solubilizers, 13 Granulation, 13 Lubricants & Glidants, 13 Film Formers & Plasticizers, 12 Topical, 10 Thickeners and Stabilizers, 9 Parenteral, 7 Disintegrants & Superdisintegrants, 6 Co-Processed Excipients, 5 Empty Capsules, 5 API Stability Enhancers, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Emulsifying Agents, 3 Chewable & Orodispersible Aids, 2 Taste Masking, 1 Rheology Modifiers

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 27 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 46 Finished Drug Prices, 3 Annual Reports

MARKET PLACE

10 APIs, 5 FDF Dossiers

PATENTS & EXCLUSIVITIES

10 Health Canada Patents

10 Health Canada Patents

REF. STANDARDS & IMPURITIES

6 USP, 9 Others

ANALYTICAL

3 BioAnalytical Methods

3 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 21999 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 3MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
paliperidone(UNII: 838F01T721) (paliperidone - UNII:838F01T721)	paliperidone	3mg

Inactive Ingredients

Ingredient Name	Actavis Pharma, Inc.	Major Pharmaceuticals	Tris Pharma Inc	Avera McKennan Hospital	Inventia Healthcare Limited	Lupin Pharmaceuticals, Inc.	REMEDYREPACK INC.	Ascent Pharmaceuticals, Inc.
AMMONIA(5138Q19F1X)
ANHYDROUS LACTOSE(3SY5LH9PMK)
BUTYL ALCOHOL(8PJ61P6TS3)
BUTYLATED HYDROXYTOLUENE(1P9D0Z171K)
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)(F68VH75CJC)
carnauba wax(R12CBM0EIZ)
CELLULOSE ACETATE(3J2P07GVB6)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
DIBUTYL SEBACATE(4W5IH7FLNY)
ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B)
ETHYLCELLULOSES(7Z8S9VYZ4B)
FD&C BLUE NO. 2--ALUMINUM LAKE(4AQJ3LG584)
FD&C RED NO. 40(WZB9127XOA)
Ferric oxide red(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
FERROSOFERRIC OXIDE(XM0M87F357)
FUMARIC ACID(88XHZ13131)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE (20000 WAMW)(KZQ570MOA5)
HYDROXYPROPYL CELLULOSE (70000 WAMW)(66O7AQV0RT)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)(G4U024CQK6)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
ISOPROPYL ALCOHOL(ND2M416302)
lactose monohydrate(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)(5KY68S2577)
POLYDEXTROSE(VH2XOU12IE)
POLYETHYLENE GLYCOL 100000(V46Y6OJ5QB)
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)
POLYETHYLENE GLYCOL 400(B697894SGQ)
POLYETHYLENE GLYCOL 7000000(G3MS6M810Y)
POLYETHYLENE GLYCOL(3WJQ0SDW1A)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
polyethylene glycols(3WJQ0SDW1A)
POLYETHYLENE OXIDE 200000(11628IH70O)
POLYETHYLENE OXIDE 7000000(G3MS6M810Y)
POLYSORBATE 80(6OZP39ZG8H)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
Povidone K30(U725QWY32X)
POVIDONE(FZ989GH94E)
POVIDONE, UNSPECIFIED(FZ989GH94E)
povidones(FZ989GH94E)
propylene glycol(6DC9Q167V3)
SHELLAC(46N107B71O)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM CHLORIDE(451W47IQ8X)
STEARIC ACID(4ELV7Z65AP)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)
TRIETHYL CITRATE(8Z96QXD6UM)

Drug Product Composition: Paliperidone

Paliperidone

Paliperidone

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

41 API Suppliers

26 USDMF

11 EU WC

3 KDMF

13 NDC API

21 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

3 Drugs in Development

PRICE INFORMATION

API Reference Price

API Exports

API Imports

FDF Exports

FDF Imports

INTERMEDIATES

10 API Suppliers

FINISHED DOSAGE FORMULATIONS

166 FDF Dossiers

45 FDA Orange Book

63 Europe

3 Canada

14 Australia

7 South Africa

34 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 3MG

TABLET, EXTENDED RELEASE;ORAL - 6MG

TABLET, EXTENDED RELEASE;ORAL - 9MG

RELATED EXCIPIENT COMPANIES

1 Minakem

1 SPI Pharma

2 Seqens

11 DKSH

1 Jai Radhe Sales

1 Boai NKY Pharmaceuticals Ltd

1 Chynops Pharma

6 Gangwal Healthcare

2 Nanjing Well Pharmaceutical

1 ACG Worldwide

5 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

22 BASF

10 Corel Pharma Chem

2 DFE Pharma

2 Finar

6 Gangwal Chemicals

6 Ideal Cures Pvt Ltd

28 Kerry

3 Kima Chemical

6 Lonza Capsugel

6 Microlex e.U

1 NEWEDGE Overseas

2 Nomisma Healthcare

3 Novo Excipients

2 Pharmatrans-Sanaq

2 Pluviaendo

1 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

4 Roquette

6 Seppic

1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

4 Sigachi Industries

2 The Dow Chemical Company

1 Ulanqab Kema New Material

1 Valens Pharmachem

EXCIPIENTS BY APPLICATIONS

TABLET, EXTENDED RELEASE;ORAL - 1.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons