Trandolapril

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ACTIVE PHARMA INGREDIENTS

15 API Suppliers, 8 USDMF, 6 CEP/COS, 3 JDMF, 3 EU WC, 4 NDC API, 6 Listed Suppliers, $ API Reference Price

INTERMEDIATES

3 Intermediates Suppliers

3 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

106 FDF Dossiers, 33 FDA Orange Book, 8 Europe, 29 Canada, 24 Australia, 8 South Africa, 4 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 5 SPI Pharma, 2 Seqens, 4 DKSH, 5 Faran Shimi Pharmaceutical, 4 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 13 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 17 BASF, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 1 Finar, 7 Gangwal Chemicals, 6 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 36 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 12 Microlex e.U, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 5 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 16 Roquette, 7 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 11 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

71 Fillers, Diluents & Binders, 47 Coating Systems & Additives, 32 Direct Compression, 29 Controlled & Modified Release, 23 Disintegrants & Superdisintegrants, 20 Thickeners and Stabilizers, 20 Lubricants & Glidants, 20 Granulation, 18 Co-Processed Excipients, 12 Solubilizers, 9 Film Formers & Plasticizers, 8 Topical, 8 Chewable & Orodispersible Aids, 7 Taste Masking, 6 Parenteral, 5 Empty Capsules, 5 API Stability Enhancers, 5 Coloring Agents, 4 Emulsifying Agents, 4 Rheology Modifiers, 4 Vegetarian Capsules, 1 Surfactant & Foaming Agents

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7 Health Canada Patents

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USFDA APPLICATION NUMBER - 20528 / DOSAGE - TABLET;ORAL - 4MG **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
TRANDOLAPRIL(UNII: 1T0N3G9CRC) (TRANDOLAPRILAT - UNII:RR6866VL0O)	TRANDOLAPRIL	4mg \| 2mg \| 1mg

Inactive Ingredients

Ingredient Name	AbbVie Inc.
CROSCARMELLOSE SODIUM(M28OL1HH48)
FERRIC OXIDE RED(1K09F3G675)
HYPROMELLOSES(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
POVIDONES(FZ989GH94E)
SODIUM STEARYL FUMARATE(7CV7WJK4UI)
STARCH, CORN(O8232NY3SJ)

Drug Product Composition: Trandolapril

Trandolapril

Trandolapril

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

15 API Suppliers

8 USDMF

6 CEP/COS

3 JDMF

3 EU WC

4 NDC API

6 Listed Suppliers

$ API Reference Price

INTERMEDIATES

3 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

106 FDF Dossiers

33 FDA Orange Book

8 Europe

29 Canada

24 Australia

8 South Africa

4 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem

5 SPI Pharma

2 Seqens

4 DKSH

5 Faran Shimi Pharmaceutical

4 Boai NKY Pharmaceuticals Ltd

1 Chynops Pharma

13 Gangwal Healthcare

2 Nanjing Well Pharmaceutical

1 ACG Worldwide

3 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

17 BASF

1 Clariant

10 Corel Pharma Chem

6 DFE Pharma

1 Finar

7 Gangwal Chemicals

6 Ideal Cures Pvt Ltd

3 Ingredion Pharma Solutions

36 Kerry

3 Kima Chemical

6 Lonza Capsugel

12 Microlex e.U

1 NEWEDGE Overseas

2 Nomisma Healthcare

2 Novo Excipients

3 Pharmatrans-Sanaq

5 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

16 Roquette

7 Seppic

6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

11 Sigachi Industries

2 The Dow Chemical Company

1 Ulanqab Kema New Material

3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

71 Fillers, Diluents & Binders

47 Coating Systems & Additives

32 Direct Compression

29 Controlled & Modified Release

23 Disintegrants & Superdisintegrants

20 Thickeners and Stabilizers

TABLET;ORAL - 1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons