Palonosetron

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ACTIVE PHARMA INGREDIENTS

43 API Suppliers, 21 USDMF, 3 JDMF, 8 EU WC, 4 KDMF, 11 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- EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INTRAVENOUS - EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 Chewable & Orodispersible Aids, 16 Parenteral, 16 Taste Masking, 11 Co-Processed Excipients, 11 Film Formers & Plasticizers, 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

DIGITAL CONTENT

64 News #PharmaBuzz

64 News #PharmaBuzz

GLOBAL SALES INFORMATION

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

MARKET PLACE

9 APIs, 6 FDF Dossiers

PATENTS & EXCLUSIVITIES

36 US Patents, 3 Health Canada Patents

REF. STANDARDS & IMPURITIES

9 Others

9 Others

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USFDA APPLICATION NUMBER - 205718 / DOSAGE - CAPSULE;ORAL - 300MG;EQ 0.5MG BASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NETUPITANT(UNII: 7732P08TIR) (NETUPITANT - UNII:7732P08TIR)	NETUPITANT	300mg
PALONOSETRON(UNII: 5D06587D6R) (PALONOSETRON - UNII:5D06587D6R)	PALONOSETRON	0.5mg

Inactive Ingredients

Ingredient Name	Eisai Inc.	Helsinn Therapeutics (U.S.), Inc.
BUTYLATED HYDROXYANISOLE(REK4960K2U)
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES(U72Q2I8C85)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
CROSCARMELLOSE SODIUM(M28OL1HH48)
EDETATE DISODIUM(7FLD91C86K)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
GELATIN(2G86QN327L)
GLYCERIN(PDC6A3C0OX)
HYDROCHLORIC ACID(QTT17582CB)
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)
POLYGLYCERYL-3 DIOLEATE(D08AL46IU2)
POVIDONE K30(U725QWY32X)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM HYDROXIDE(55X04QC32I)
SODIUM STEARYL FUMARATE(7CV7WJK4UI)
SORBITOL(506T60A25R)
SUCROSE LAURATE(05Q7CD0E49)
TITANIUM DIOXIDE(15FIX9V2JP)
WATER(059QF0KO0R)

Setid 2daa0c22 3051 4f12 A860 E5404c862760 Applno 205718 Form Capsule Oral Dosage 300mg Eq 0 5mg Base - 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

11 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