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Approved Drug Products containing Prestwick3_000478 listed in the FDA Orange Book. Original Data : FDA Website

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Product

Prestwick3_000478
FDA Orange Book

Renejix: CDMO with expertise in small molecule oral dosage, delivery tech, and multi-modality manufacturing.

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SPI Pharma has been solving formulation challenges using superior functional materials.

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xyz-pharma-m-2024-10-07

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Ribobay has expertise in oligonucleotides from siRNA, Antisense Oligonucleotides, miRNAs, and aptamers & Oligonucleotides CXOs.

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AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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xyz-pharma-m-2024-10-07

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Prestwick3_000478

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

22 API Suppliers, 16 USDMF, 9 CEP/COS, 1 JDMF, 4 EU WC, 17 KDMF, 6 NDC API, 10 Listed Suppliers, $ API Reference Price

22 API Suppliers
16 USDMF
9 CEP/COS
1 JDMF
4 EU WC
17 KDMF
6 NDC API
10 Listed Suppliers
$ API Reference Price

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Imports

API Reference Price
API Exports
API Imports
FDF Imports

INTERMEDIATES

1 API Suppliers

1 API Suppliers

FINISHED DOSAGE FORMULATIONS

203 FDF Dossiers, 44 FDA Orange Book, 96 Europe, 8 Canada, 22 Australia, 7 South Africa, 26 Listed Dossiers

203 FDF Dossiers
44 FDA Orange Book
96 Europe
8 Canada
22 Australia
7 South Africa
26 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Minakem, 5 SPI Pharma, 2 Seqens, 3 DKSH, 2 Jai Radhe Sales, 1 Pharm-RX Chemical, 1 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 12 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 5 Actylis, 3 Aeon Procare, 1 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 21 BASF, 1 Clariant, 11 Corel Pharma Chem, 5 DFE Pharma, 2 Finar, 11 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 36 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 7 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 3 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 15 Roquette, 14 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 2 Valens Pharmachem, 1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

63 Fillers, Diluents & Binders, 46 Coating Systems & Additives, 34 Direct Compression, 29 Solubilizers, 29 Controlled & Modified Release, 24 Thickeners and Stabilizers, 19 Granulation, 18 Topical, 18 Co-Processed Excipients, 16 Film Formers & Plasticizers, 15 Disintegrants & Superdisintegrants, 13 Parenteral, 13 Lubricants & Glidants, 9 Emulsifying Agents, 8 Chewable & Orodispersible Aids, 8 API Stability Enhancers, 7 Taste Masking, 5 Empty Capsules, 4 Coloring Agents, 4 Rheology Modifiers, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents

63 Fillers, Diluents & Binders
46 Coating Systems & Additives
34 Direct Compression
29 Solubilizers
29 Controlled & Modified Release
24 Thickeners and Stabilizers
19 Granulation
18 Topical
18 Co-Processed Excipients
16 Film Formers & Plasticizers
15 Disintegrants & Superdisintegrants
13 Parenteral
13 Lubricants & Glidants
9 Emulsifying Agents
8 Chewable & Orodispersible Aids
8 API Stability Enhancers
7 Taste Masking
5 Empty Capsules
4 Coloring Agents
4 Rheology Modifiers
4 Vegetarian Capsules
4 Surfactant & Foaming Agents

DIGITAL CONTENT

6 NEWS #PharmaBuzz

6 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

75 Finished Drug Prices, 3 Annual Reports

75 Finished Drug Prices
3 Annual Reports

MARKET PLACE

6 APIs, 2 FDF Dossiers

6 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

10 Health Canada Patents

10 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 2 Others

2 EDQM
1 USP
2 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 390 Xls

Filters

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FILTER :

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44 All

01 5ASTRAZENECA

02 3AUROBINDO PHARMA LTD

03 3ENDO OPERATIONS

04 3GLENMARK PHARMS LTD

05 3HERITAGE

06 3JUBILANT GENERICS

07 3MYLAN

08 3ORBION PHARMS

09 3SUN PHARM INDS LTD

10 3SUN PHARM INDUSTRIES

11 3TORRENT PHARMS LTD

12 3WOCKHARDT

13 3YILING

14 3YUNG SHIN PHARM

filter Dosage Reset all filters

44 All

01 44TABLET, EXTENDED RELEASE;ORAL

filter Regulatory Info Reset all filters

44 All

01 17DISCN

02 27RX

filter Brand Name Reset all filters

44 All

01 39FELODIPINE

02 2LEXXEL

03 3PLENDIL

filter RLD Reset all filters

44 All

01 41No

02 3Yes

FDF Dossiers
FDA Orange Book
Europe
Canada
Australia
South Africa
Listed Dossiers

List of Suppliers

Product Main Page

01

ASTRAZENECA

AAPS 2024

Not Confirmed

ASTRAZENECA

AAPS 2024

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

RLD : Yes

TE Code :

Brand Name : PLENDIL

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1991-07-25

Application Number : 19834

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

ASTRAZENECA

AAPS 2024

Not Confirmed

ASTRAZENECA

AAPS 2024

Not Confirmed

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Digital Content

RLD : Yes

TE Code :

Brand Name : PLENDIL

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1991-07-25

Application Number : 19834

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

ASTRAZENECA

AAPS 2024

Not Confirmed

ASTRAZENECA

AAPS 2024

Not Confirmed

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Digital Content

RLD : Yes

TE Code :

Brand Name : PLENDIL

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1994-09-22

Application Number : 19834

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

ASTRAZENECA

AAPS 2024

Not Confirmed

ASTRAZENECA

AAPS 2024

Not Confirmed

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Digital Content

RLD : No

TE Code :

ENALAPRIL MALEATE; FELODIPINE

Brand Name : LEXXEL

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 5MG;5MG

Approval Date : 1996-12-27

Application Number : 20668

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

ASTRAZENECA

AAPS 2024

Not Confirmed

ASTRAZENECA

AAPS 2024

Not Confirmed

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Digital Content

RLD : No

TE Code :

ENALAPRIL MALEATE; FELODIPINE

Brand Name : LEXXEL

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 5MG;2.5MG

Approval Date : 1998-10-28

Application Number : 20668

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

SUN PHARM INDUSTRIES

AAPS 2024

Not Confirmed

SUN PHARM INDUSTRIES

AAPS 2024

Not Confirmed

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Digital Content

RLD : No

TE Code :

Brand Name : FELODIPINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 2.5MG

Approval Date : 2004-11-02

Application Number : 75896

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

SUN PHARM INDUSTRIES

AAPS 2024

Not Confirmed

SUN PHARM INDUSTRIES

AAPS 2024

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

RLD : No

TE Code :

Brand Name : FELODIPINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 5MG

Approval Date : 2004-11-02

Application Number : 75896

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

SUN PHARM INDUSTRIES

AAPS 2024

Not Confirmed

SUN PHARM INDUSTRIES

AAPS 2024

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

RLD : No

TE Code :

Brand Name : FELODIPINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG

Approval Date : 2004-11-02

Application Number : 75896

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

MYLAN

AAPS 2024

Not Confirmed

MYLAN

AAPS 2024

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Post an Enquiry

Digital Content

RLD : No

TE Code :

Brand Name : FELODIPINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 2.5MG

Approval Date : 2008-04-17

Application Number : 78855

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

MYLAN

AAPS 2024

Not Confirmed

MYLAN

AAPS 2024

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

RLD : No

TE Code :

Brand Name : FELODIPINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 5MG

Approval Date : 2008-04-17

Application Number : 78855

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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