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Janssen brand of paliperidone extended release

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

43 API Suppliers, 26 USDMF, 10 EU WC, 3 KDMF, 14 NDC API, 22 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

INTERMEDIATES

20 Intermediate Suppliers

20 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

177 FDF Dossiers, 56 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TABLET, EXTENDED RELEASE;ORAL - 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 3MG, TABLET, EXTENDED RELEASE;ORAL - 6MG, TABLET, EXTENDED RELEASE;ORAL - 9MG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, 13 DKSH, 1 Boai NKY Pharmaceuticals Ltd, 3 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 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 Topical, 14 Solubilizers, 13 Lubricants & Glidants, 12 Thickeners and Stabilizers, 12 Film Formers & Plasticizers, 11 Direct Compression, 7 Parenteral, 5 Empty Capsules, 5 API Stability Enhancers, 5 Coloring Agents, 4 Emulsifying Agents, 4 Disintegrants & Superdisintegrants, 4 Vegetarian Capsules, 3 Rheology Modifiers, 3 Co-Processed Excipients, 2 Chewable & Orodispersible Aids, 2 Taste Masking

DIGITAL CONTENT

32 News #PharmaBuzz

32 News #PharmaBuzz

GLOBAL SALES INFORMATION

13 US Medicaid Prescriptions, 46 Regulatory FDF Prices, 3 Annual Reports

MARKET PLACE

11 APIs, 5 FDF Dossiers

PATENTS & EXCLUSIVITIES

10 Health Canada Patents

10 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 USP, 3 Others

ANALYTICAL

3 BioAnalytical Methods

3 BioAnalytical Methods

$ Xls download

Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
29/07/2025	Pharmathen SA	Greece	PHARMATHEN SA	31062	PALIPERIDONE	2016-12-27	Active	II	Complete	2017-02-27	2016-12-01
29/07/2025	TAPI Technology & API Services	Israel	TAPI NL BV	27514	PALIPERIDONE	2013-10-10	Active	II	Complete	2014-04-03	2013-09-12

Janssen Brand Of Paliperidone Extended Release

Janssen brand of paliperidone extended release

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

43 API Suppliers

26 USDMF

10 EU WC

3 KDMF

14 NDC API

22 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

INTERMEDIATES

20 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

177 FDF Dossiers

56 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

13 DKSH

1 Boai NKY Pharmaceuticals Ltd

3 Gangwal Healthcare

2 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

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 Topical

14 Solubilizers

13 Lubricants & Glidants

12 Thickeners and Stabilizers

12 Film Formers & Plasticizers

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