Tekturna

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

9 API Suppliers, 4 USDMF, 1 EU WC, 3 NDC API, 4 Listed Suppliers

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

INTERMEDIATES

5 Intermediate Suppliers

5 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

45 FDF Dossiers, 20 FDA Orange Book, 25 Europe

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 150MG BASE, TABLET;ORAL - EQ 300MG BASE, TABLET;ORAL - EQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 150MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 300MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 300MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 6 DKSH, 5 Boai NKY Pharmaceuticals Ltd, 2 Gangwal Healthcare, 1 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 22 BASF, 10 Corel Pharma Chem, 2 DFE Pharma, 1 Esteem Industries, 1 Finar, 8 Gangwal Chemicals, 4 Ideal Cures, 11 Kerry, 1 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 10 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 2 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 10 Roquette, 6 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 9 Sigachi Industries, 2 Silverline Chemicals, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

40 Coating Systems & Additives, 32 Fillers, Diluents & Binders, 22 Controlled & Modified Release, 19 Thickeners and Stabilizers, 18 Disintegrants & Superdisintegrants, 18 Direct Compression, 17 Granulation, 13 Solubilizers, 12 Lubricants & Glidants, 8 Co-Processed Excipients, 8 Topical, 8 Chewable & Orodispersible Aids, 7 Film Formers & Plasticizers, 5 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules, 4 API Stability Enhancers, 4 Taste Masking, 4 Emulsifying Agents, 4 Rheology Modifiers, 2 Parenteral

DIGITAL CONTENT

13 News #PharmaBuzz

13 News #PharmaBuzz

GLOBAL SALES INFORMATION

4 US Medicaid Prescriptions, 1 Annual Reports

MARKET PLACE

1 APIs, 1 FDF Dossiers

PATENTS & EXCLUSIVITIES

14 US Patents, 10 Health Canada Patents

Xls

Filters

Xls

USFDA APPLICATION NUMBER - 21985 / DOSAGE - TABLET;ORAL - EQ 150MG BASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALISKIREN HEMIFUMARATE(UNII: C8A0P8G029) (ALISKIREN - UNII:502FWN4Q32)	ALISKIREN	300mg \| 150mg

Inactive Ingredients

Ingredient Name	A-S Medication Solutions	Avera McKennan Hospital	Novartis Pharmaceuticals Corporation
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)
CROSPOVIDONE(2S7830E561)
CROSPOVIDONE(68401960MK)
FERRIC OXIDE RED(1K09F3G675)
FERROSOFERRIC OXIDE(XM0M87F357)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
SILICON DIOXIDE(ETJ7Z6XBU4)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)

Setid 833c7a0b 5f64 4363 94d5 9a179049113a Applno 21985 Form Tablet Oral Dosage Eq 150mg Base - Drug Product Composition: Tekturna

Tekturna

Tekturna

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

9 API Suppliers

4 USDMF

1 EU WC

3 NDC API

4 Listed Suppliers

DEVELOPMENTS

3 Drugs in Development

INTERMEDIATES

5 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

45 FDF Dossiers

20 FDA Orange Book

25 Europe

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 150MG BASE

TABLET;ORAL - EQ 300MG BASE

TABLET;ORAL - EQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 150MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 300MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 300MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 SPI Pharma

6 DKSH

5 Boai NKY Pharmaceuticals Ltd

2 Gangwal Healthcare

1 ACG Worldwide

3 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

2 Ashland

22 BASF

10 Corel Pharma Chem

2 DFE Pharma

1 Esteem Industries

1 Finar

8 Gangwal Chemicals

4 Ideal Cures

11 Kerry

1 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

10 Microlex e.U

2 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

3 Novo Excipients

3 Pharmatrans-Sanaq

2 Pluviaendo

2 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

10 Roquette

6 Seppic

3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

9 Sigachi Industries

2 Silverline Chemicals

2 The Dow Chemical Company

1 Ulanqab Kema New Material

2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

40 Coating Systems & Additives

32 Fillers, Diluents & Binders

22 Controlled & Modified Release

19 Thickeners and Stabilizers

18 Disintegrants & Superdisintegrants

18 Direct Compression

17 Granulation

13 Solubilizers

12 Lubricants & Glidants

8 Co-Processed Excipients

8 Topical

8 Chewable & Orodispersible Aids

TABLET;ORAL - EQ 150MG BASE;12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - EQ 150MG BASE;25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - EQ 300MG BASE;12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - EQ 300MG BASE;25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons