Palonosetron

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ACTIVE PHARMA INGREDIENTS

43 API Suppliers, 21 USDMF, 3 JDMF, 8 EU WC, 4 KDMF, 12 NDC API, 23 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

31 Drugs in Development

31 Drugs in Development

INTERMEDIATES

13 Intermediate Suppliers

13 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

96 FDF Dossiers, 34 FDA Orange Book, 24 Europe, 2 Canada, 4 Australia, 9 South Africa, 23 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 300MG;EQ 0.5MG BASE, SOLUTION;INTRAVENOUS - EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML), POWDER;INTRAVENOUS - EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL, SOLUTION;INTRAVENOUS - EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML), INJECTABLE;INTRAVENOUS - EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INTRAVENOUS - EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Minakem, 2 Rochem International Inc, 16 SPI Pharma, 7 DKSH, 3 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 1 Pfanstiehl, 4 Kirsch Pharma, 4 ACG Worldwide, 6 Actylis, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 BASF, 1 CD Formulation, 3 DFE Pharma, 5 Gangwal Chemicals, 1 Ideal Cures, 2 Ingredion Pharma Solutions, 2 Kerry, 2 Keval Exports, 3 Lonza Capsugel, 9 Microlex e.U, 3 Nitika Pharmaceutical Specialities, 2 Pharmatrans-Sanaq, 4 Pluviaendo, 3 Prachin Chemical, 1 Qualicaps, 22 Roquette, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 9 Sigachi Industries, 3 Silverline Chemicals, 1 Ulanqab Kema New Material, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

48 Fillers, Diluents & Binders, 18 Disintegrants & Superdisintegrants, 18 Direct Compression, 17 Thickeners and Stabilizers, 17 Lubricants & Glidants, 16 Taste Masking, 16 Chewable & Orodispersible Aids, 16 Parenteral, 11 Film Formers & Plasticizers, 11 Co-Processed Excipients, 10 Granulation, 9 Coating Systems & Additives, 8 Empty Capsules, 5 Controlled & Modified Release, 3 Solubilizers, 3 Emulsifying Agents, 2 API Stability Enhancers, 2 Coloring Agents, 2 Topical, 2 Rheology Modifiers, 1 Soft Gelatin

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17 US Medicaid Prescriptions, 10 Regulatory FDF Prices, 10 Annual Reports

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9 APIs, 6 FDF Dossiers

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36 US Patents, 3 Health Canada Patents

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USFDA APPLICATION NUMBER - 21372 / DOSAGE - INJECTABLE;INTRAVENOUS - EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) **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
PALONOSETRON HYDROCHLORIDE(UNII: 23310D4I19) (PALONOSETRON - UNII:5D06587D6R)	PALONOSETRON	0.075mg in 1.5 \| 0.25mg in 5

Inactive Ingredients

Ingredient Name	Accord Healthcare, Inc.	Eisai Inc.
CITRIC ACID MONOHYDRATE(2968PHW8QP)
EDETATE DISODIUM(7FLD91C86K)
MANNITOL(3OWL53L36A)
SODIUM CITRATE(1Q73Q2JULR)
WATER(059QF0KO0R)

Setid 1b51c34d 9631 4520 83af 6f6fb21a58a4 Applno 21372 Form Injectable Intravenous Dosage Eq 0 25mg Base 5ml Eq 0 05mg Base Ml - Drug Product Composition: Palonosetron

Palonosetron

Palonosetron

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

43 API Suppliers

21 USDMF

3 JDMF

8 EU WC

4 KDMF

12 NDC API

23 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

31 Drugs in Development

INTERMEDIATES

13 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

96 FDF Dossiers

34 FDA Orange Book

24 Europe

2 Canada

4 Australia

9 South Africa

23 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 300MG;EQ 0.5MG BASE

SOLUTION;INTRAVENOUS - EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)

POWDER;INTRAVENOUS - EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL

SOLUTION;INTRAVENOUS - EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML)

INJECTABLE;INTRAVENOUS - EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INTRAVENOUS - EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE;ORAL - EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 EUROAPI

1 Minakem

2 Rochem International Inc

16 SPI Pharma

7 DKSH

3 Boai NKY Pharmaceuticals Ltd

6 Gangwal Healthcare

2 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

1 Pfanstiehl

4 Kirsch Pharma

4 ACG Worldwide

6 Actylis

5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 BASF

1 CD Formulation

3 DFE Pharma

5 Gangwal Chemicals

1 Ideal Cures

2 Ingredion Pharma Solutions

2 Kerry

2 Keval Exports

3 Lonza Capsugel

9 Microlex e.U

3 Nitika Pharmaceutical Specialities

2 Pharmatrans-Sanaq

4 Pluviaendo

3 Prachin Chemical

1 Qualicaps

22 Roquette

5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

2 Shijiazhuang Huaxu Pharmaceutical

9 Sigachi Industries

3 Silverline Chemicals

1 Ulanqab Kema New Material

3 Vasa Pharmachem

1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

48 Fillers, Diluents & Binders

18 Disintegrants & Superdisintegrants

18 Direct Compression

17 Thickeners and Stabilizers

INJECTABLE;INTRAVENOUS - EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

INJECTABLE;INTRAVENOUS - EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE;ORAL - EQ 0.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons