Palonosetron

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ACTIVE PHARMA INGREDIENTS

40 API Suppliers, 22 USDMF, 3 JDMF, 9 EU WC, 4 KDMF, 13 NDC API, 23 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

11 Drugs in Development

11 Drugs in Development

INTERMEDIATES

11 Intermediates Suppliers

11 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

90 FDF Dossiers, 34 FDA Orange Book, 20 Europe, 2 Canada, 6 Australia, 7 South Africa, 21 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- EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INTRAVENOUS - EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

1 Minakem, 2 Rochem International Inc, 15 SPI Pharma, 7 DKSH, 3 Faran Shimi Pharmaceutical, 3 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 9 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 6 Actylis, 1 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 BASF, 3 DFE Pharma, 5 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 6 Kerry, 3 Lonza Capsugel, 9 Microlex e.U, 1 NEWEDGE Overseas, 2 Pharmatrans-Sanaq, 4 Pluviaendo, 4 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, 1 Ulanqab Kema New Material, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

47 Fillers, Diluents & Binders, 23 Direct Compression, 18 Lubricants & Glidants, 17 Thickeners and Stabilizers, 17 Disintegrants & Superdisintegrants, 14 Taste Masking, 14 Chewable & Orodispersible Aids, 14 Co-Processed Excipients, 11 Film Formers & Plasticizers, 11 Coating Systems & Additives, 11 Parenteral, 10 Granulation, 8 Empty Capsules, 7 Controlled & Modified Release, 3 API Stability Enhancers, 3 Emulsifying Agents, 2 Solubilizers, 2 Coloring Agents, 2 Rheology Modifiers, 1 Soft Gelatin, 1 Topical

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 62 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 18 Finished Drug Prices, 10 Annual Reports

MARKET PLACE

7 APIs, 6 FDF Dossiers

PATENTS & EXCLUSIVITIES

76 US Patents, 3 Health Canada Patents

REF. STANDARDS & IMPURITIES

7 USP, 7 Others

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USFDA APPLICATION NUMBER - 210493 / DOSAGE - POWDER;INTRAVENOUS - EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FOSNETUPITANT(UNII: T672P80L2S) (FOSNETUPITANT - UNII:T672P80L2S)	FOSNETUPITANT	260mg \| 260mg in 20 \| 260mg in 20
NETUPITANT(UNII: 7732P08TIR) (NETUPITANT - UNII:7732P08TIR)	NETUPITANT	300mg
PALONOSETRON HYDROCHLORIDE(UNII: 23310D4I19) (PALONOSETRON - UNII:5D06587D6R)	PALONOSETRON	0.28mg \| 0.28mg in 20 \| 0.28mg in 20
PALONOSETRON(UNII: 5D06587D6R) (PALONOSETRON - UNII:5D06587D6R)	PALONOSETRON	0.5mg

Inactive Ingredients

Ingredient Name	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)

Drug Product Composition: Palonosetron

Palonosetron

Palonosetron

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

40 API Suppliers

22 USDMF

3 JDMF

9 EU WC

4 KDMF

13 NDC API

23 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

11 Drugs in Development

INTERMEDIATES

11 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

90 FDF Dossiers

34 FDA Orange Book

20 Europe

2 Canada

6 Australia

7 South Africa

21 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

1 Minakem

2 Rochem International Inc

15 SPI Pharma

7 DKSH

3 Faran Shimi Pharmaceutical

3 Boai NKY Pharmaceuticals Ltd

1 Chynops Pharma

9 Gangwal Healthcare

2 Nanjing Well Pharmaceutical

1 Pfanstiehl

4 ACG Worldwide

6 Actylis

1 Alcedo Pharmachem

6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 BASF

3 DFE Pharma

5 Gangwal Chemicals

1 Ideal Cures Pvt Ltd

2 Ingredion Pharma Solutions

6 Kerry

3 Lonza Capsugel

9 Microlex e.U

1 NEWEDGE Overseas

2 Pharmatrans-Sanaq

4 Pluviaendo

4 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

1 Ulanqab Kema New Material

3 Vasa Pharmachem

1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

47 Fillers, Diluents & Binders

23 Direct Compression

18 Lubricants & Glidants

17 Thickeners and Stabilizers

17 Disintegrants & Superdisintegrants

14 Taste Masking

14 Chewable & Orodispersible Aids

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