Presinex

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

59 API Suppliers, 20 USDMF, 14 CEP/COS, 2 JDMF, 3 EU WC, 9 KDMF, 30 NDC API, 18 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

10 Drugs in Development

10 Drugs in Development

FINISHED DOSAGE FORMULATIONS

307 FDF Dossiers, 53 FDA Orange Book, 208 Europe, 10 Canada, 12 Australia, 8 South Africa, 16 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;NASAL - 0.01%, SPRAY, METERED;NASAL - 0.01MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 0.004MG/ML, TABLET;ORAL - 0.1MG, TABLET;ORAL - 0.2MG, SPRAY, METERED;NASAL - 0.00083MG/SPRAY, SPRAY, METERED;NASAL - 0.00166MG/SPRAY, SPRAY, METERED;NASAL - 0.15MG/SPRAY, SPRAY, METERED;NASAL - 0.01MG/SPRAY, TABLET;SUBLINGUAL - 0.0277MG, TABLET;SUBLINGUAL - 0.0553MG

RELATED EXCIPIENT COMPANIES

3 SPI Pharma, 1 DKSH, 8 Boai NKY Pharmaceuticals Ltd, 2 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 3 Kirsch Pharma, 7 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 15 BASF, 1 CD Formulation, 2 DFE Pharma, 1 Finar, 7 Gangwal Chemicals, 2 Ingredion Pharma Solutions, 12 Kerry, 10 Microlex e.U, 1 Nitika Pharmaceutical Specialities, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 4 Pluviaendo, 1 Prachin Chemical, 7 Roquette, 5 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 3 Sigachi Industries, 1 Silverline Chemicals, 1 Symrise, 2 Ulanqab Kema New Material, 1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

39 Fillers, Diluents & Binders, 19 Direct Compression, 19 Disintegrants & Superdisintegrants, 17 Solubilizers, 17 Granulation, 13 Lubricants & Glidants, 13 Parenteral, 10 Thickeners and Stabilizers, 9 Chewable & Orodispersible Aids, 7 Controlled & Modified Release, 7 Emulsifying Agents, 7 Co-Processed Excipients, 5 Taste Masking, 5 Topical, 5 Surfactant & Foaming Agents, 3 Film Formers & Plasticizers, 3 Coating Systems & Additives, 2 API Stability Enhancers

DIGITAL CONTENT

31 News #PharmaBuzz

31 News #PharmaBuzz

GLOBAL SALES INFORMATION

18 US Medicaid Prescriptions, 106 Regulatory FDF Prices

MARKET PLACE

9 APIs, 8 FDF Dossiers

PATENTS & EXCLUSIVITIES

12 US Patents, 14 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 3 Others

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USFDA APPLICATION NUMBER - 20355 / DOSAGE - SPRAY, METERED;NASAL - 0.15MG/SPRAY

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DESMOPRESSIN ACETATE(UNII: XB13HYU18U) (DESMOPRESSIN - UNII:ENR1LLB0FP)	DESMOPRESSIN ACETATE	1.5mg in 1

Inactive Ingredients

Ingredient Name	CSL Behring LLC
BENZALKONIUM CHLORIDE(F5UM2KM3W7)
CITRIC ACID MONOHYDRATE(2968PHW8QP)
SODIUM CHLORIDE(451W47IQ8X)
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE(94255I6E2T)
WATER(059QF0KO0R)

Setid 30d4c387 B99c 49f8 A8bd De23fdafb739 Applno 20355 Form Spray Metered Nasal Dosage 0 15mg Spray - Drug Product Composition: Presinex

Presinex

Presinex

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

59 API Suppliers

20 USDMF

14 CEP/COS

2 JDMF

3 EU WC

9 KDMF

30 NDC API

18 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

10 Drugs in Development

FINISHED DOSAGE FORMULATIONS

307 FDF Dossiers

53 FDA Orange Book

208 Europe

10 Canada

12 Australia

8 South Africa

16 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;NASAL - 0.01%

SPRAY, METERED;NASAL - 0.01MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - 0.004MG/ML

TABLET;ORAL - 0.1MG

TABLET;ORAL - 0.2MG

SPRAY, METERED;NASAL - 0.00083MG/SPRAY

SPRAY, METERED;NASAL - 0.00166MG/SPRAY

SPRAY, METERED;NASAL - 0.15MG/SPRAY

SPRAY, METERED;NASAL - 0.01MG/SPRAY

TABLET;SUBLINGUAL - 0.0277MG

TABLET;SUBLINGUAL - 0.0553MG

RELATED EXCIPIENT COMPANIES

3 SPI Pharma

1 DKSH

8 Boai NKY Pharmaceuticals Ltd

2 Gangwal Healthcare

3 Nanjing Well Pharmaceutical

3 Kirsch Pharma

7 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

2 Ashland

15 BASF

1 CD Formulation

2 DFE Pharma

1 Finar

7 Gangwal Chemicals

2 Ingredion Pharma Solutions

12 Kerry

10 Microlex e.U

1 Nitika Pharmaceutical Specialities

2 Novo Excipients

2 Pharmatrans-Sanaq

4 Pluviaendo

1 Prachin Chemical

7 Roquette

5 Seppic

3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

3 Sigachi Industries

1 Silverline Chemicals

1 Symrise

2 Ulanqab Kema New Material

1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

39 Fillers, Diluents & Binders

19 Direct Compression

19 Disintegrants & Superdisintegrants

17 Solubilizers

17 Granulation

13 Lubricants & Glidants

SPRAY, METERED;NASAL - 0.01MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons