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Lapenax

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ACTIVE PHARMA INGREDIENTS

29 API Suppliers, 16 USDMF, 10 CEP/COS, 1 JDMF, 5 EU WC, 3 KDMF, 9 NDC API, 15 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

203 FDF Dossiers, 60 FDA Orange Book, 60 Europe, 12 Canada, 36 Australia, 9 South Africa, 26 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 100MG, TABLET;ORAL - 200MG, TABLET;ORAL - 25MG, TABLET;ORAL - 50MG, SUSPENSION;ORAL - 50MG/ML, TABLET, ORALLY DISINTEGRATING;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, ORALLY DISINTEGRATING;ORAL - 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, ORALLY DISINTEGRATING;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, ORALLY DISINTEGRATING;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, ORALLY DISINTEGRATING;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Minakem, 5 Evonik, 5 Rochem International Inc, 20 SPI Pharma, 3 DKSH, 1 Pharm-RX Chemical, 6 Faran Shimi Pharmaceutical, 6 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 7 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 Pramukh Pharmachem, 1 Zeal MediPharma, 3 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 15 BASF, 2 Corel Pharma Chem, 6 DFE Pharma, 6 Gangwal Chemicals, 2 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 28 Kerry, 13 Microlex e.U, 1 NEWEDGE Overseas, 1 Novo Excipients, 4 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 28 Roquette, 1 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 3 Silverline Chemicals, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

85 Fillers, Diluents & Binders, 30 Direct Compression, 29 Taste Masking, 24 Disintegrants & Superdisintegrants, 22 Granulation, 21 Lubricants & Glidants, 20 Chewable & Orodispersible Aids, 20 Thickeners and Stabilizers, 20 Coating Systems & Additives, 19 Film Formers & Plasticizers, 18 Co-Processed Excipients, 13 Parenteral, 13 Controlled & Modified Release, 8 Solubilizers, 6 Topical, 4 API Stability Enhancers, 3 Rheology Modifiers, 3 Emulsifying Agents, 1 Soft Gelatin, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

29 News #PharmaBuzz

29 News #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 57 Regulatory FDF Prices

MARKET PLACE

5 APIs, 7 FDF Dossiers, 1 Intermediates

PATENTS & EXCLUSIVITIES

1 US Patents

1 US Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 7 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

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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
25/04/2025	Cohance Lifesciences	India	COHANCE LIFESCIENCES LTD	31999	CLOZAPINE USP	2017-08-24	Active	II	Complete	2019-01-29	2018-12-07
25/04/2025	Mankind Pharma	India	MANKIND PHARMA LTD	37540	CLOZAPINE USP	2023-02-01	Active	II	N/A

Lapenax

Lapenax

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

29 API Suppliers

16 USDMF

10 CEP/COS

1 JDMF

5 EU WC

3 KDMF

9 NDC API

15 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

203 FDF Dossiers

60 FDA Orange Book

60 Europe

12 Canada

36 Australia

9 South Africa

26 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 100MG

TABLET;ORAL - 200MG

TABLET;ORAL - 25MG

TABLET;ORAL - 50MG

SUSPENSION;ORAL - 50MG/ML

TABLET, ORALLY DISINTEGRATING;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, ORALLY DISINTEGRATING;ORAL - 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, ORALLY DISINTEGRATING;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, ORALLY DISINTEGRATING;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, ORALLY DISINTEGRATING;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 EUROAPI

1 Minakem

5 Evonik

5 Rochem International Inc

20 SPI Pharma

3 DKSH

1 Pharm-RX Chemical

6 Faran Shimi Pharmaceutical

6 Boai NKY Pharmaceuticals Ltd

1 Chynops Pharma

7 Gangwal Healthcare

2 Nanjing Well Pharmaceutical

1 Pfanstiehl

1 Pramukh Pharmachem

1 Zeal MediPharma

3 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Ashland

15 BASF

2 Corel Pharma Chem

6 DFE Pharma

6 Gangwal Chemicals

2 Ideal Cures Pvt Ltd

4 Ingredion Pharma Solutions

28 Kerry

13 Microlex e.U

1 NEWEDGE Overseas

1 Novo Excipients

4 Pharmatrans-Sanaq

7 Pluviaendo

4 Prachin Chemical

28 Roquette

1 Seppic

5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

2 Shijiazhuang Huaxu Pharmaceutical

11 Sigachi Industries

3 Silverline Chemicals

TABLET, ORALLY DISINTEGRATING;ORAL - 100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, ORALLY DISINTEGRATING;ORAL - 12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, ORALLY DISINTEGRATING;ORAL - 150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, ORALLY DISINTEGRATING;ORAL - 200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, ORALLY DISINTEGRATING;ORAL - 25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons