Paliperidone

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ACTIVE PHARMA INGREDIENTS

42 API Suppliers, 26 USDMF, 7 EU WC, 3 KDMF, 13 NDC API, 22 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

30 Drugs in Development

30 Drugs in Development

INTERMEDIATES

20 Intermediate Suppliers

20 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

391 FDF Dossiers, 60 FDA Orange Book, 273 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TABLET, EXTENDED RELEASE;ORAL - 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 3MG, TABLET, EXTENDED RELEASE;ORAL - 6MG, TABLET, EXTENDED RELEASE;ORAL - 9MG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, 13 DKSH, 1 Boai NKY Pharmaceuticals Ltd, 3 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Kirsch Pharma, 1 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 2 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 22 BASF, 1 CD Formulation, 10 Corel Pharma Chem, 2 DFE Pharma, 1 Esteem Industries, 2 Finar, 6 Gangwal Chemicals, 4 Ideal Cures, 20 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 6 Microlex e.U, 1 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 2 Pharmatrans-Sanaq, 2 Pluviaendo, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 4 Roquette, 6 Seppic, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 3 Sigachi Industries, 2 The Dow Chemical Company, 1 Valens Pharmachem

EXCIPIENTS BY APPLICATIONS

47 Coating Systems & Additives, 30 Fillers, Diluents & Binders, 22 Controlled & Modified Release, 16 Granulation, 14 Solubilizers, 14 Topical, 13 Thickeners and Stabilizers, 13 Lubricants & Glidants, 12 Film Formers & Plasticizers, 11 Direct Compression, 8 Parenteral, 5 Empty Capsules, 5 API Stability Enhancers, 5 Coloring Agents, 5 Emulsifying Agents, 4 Disintegrants & Superdisintegrants, 4 Vegetarian Capsules, 3 Co-Processed Excipients, 3 Rheology Modifiers, 2 Taste Masking, 2 Chewable & Orodispersible Aids

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33 News #PharmaBuzz

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13 US Medicaid Prescriptions, 28 Regulatory FDF Prices, 3 Annual Reports

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11 APIs, 5 FDF Dossiers

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5 Health Canada Patents

5 Health Canada Patents

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3 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 21999 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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

Inactive Ingredients

Ingredient Name	Avera McKennan Hospital	REMEDYREPACK INC.
BUTYLATED HYDROXYTOLUENE(1P9D0Z171K)
CARNAUBA WAX(R12CBM0EIZ)
cellulose acetate(3J2P07GVB6)
ferrosoferric oxide(XM0M87F357)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
hypromelloses(3NXW29V3WO)
lactose monohydrate(EWQ57Q8I5X)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
polyethylene glycols(3WJQ0SDW1A)
POVIDONE, UNSPECIFIED(FZ989GH94E)
povidones(FZ989GH94E)
propylene glycol(6DC9Q167V3)
sodium chloride(451W47IQ8X)
STEARIC ACID(4ELV7Z65AP)
titanium dioxide(15FIX9V2JP)
triacetin(XHX3C3X673)

Setid 7cd7e46a Fba1 454c 9305 D48574b0b4b0 Applno 21999 Form Tablet Extended Release Oral Dosage 12mg - Drug Product Composition: Paliperidone

Paliperidone

Paliperidone

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

42 API Suppliers

26 USDMF

7 EU WC

3 KDMF

13 NDC API

22 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

30 Drugs in Development

INTERMEDIATES

20 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

391 FDF Dossiers

60 FDA Orange Book

273 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

13 DKSH

1 Boai NKY Pharmaceuticals Ltd

3 Gangwal Healthcare

2 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

2 Kirsch Pharma

1 ACG Worldwide

5 Actylis

1 Aeon Procare

2 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

2 Ashland

22 BASF

1 CD Formulation

10 Corel Pharma Chem

2 DFE Pharma

1 Esteem Industries

2 Finar

6 Gangwal Chemicals

4 Ideal Cures

20 Kerry

3 Kima Chemical

6 Lonza Capsugel

6 Microlex e.U

1 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

3 Novo Excipients

2 Pharmatrans-Sanaq

2 Pluviaendo

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

4 Roquette

6 Seppic

1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

3 Sigachi Industries

2 The Dow Chemical Company

1 Valens Pharmachem

EXCIPIENTS BY APPLICATIONS

47 Coating Systems & Additives

30 Fillers, Diluents & Binders

22 Controlled & Modified Release

16 Granulation

14 Solubilizers

14 Topical

13 Thickeners and Stabilizers

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