Renedil;Feloday;Plendil | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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Renedil;Feloday;Plendil
FDA Orange Book

AMI Lifesciences is Driven by Chemistry. Powered by People.

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Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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Bhavna Laboratories is an API & Intermediate manufacturer focusing on the muscle relaxant & ophthalmic segments.

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Zach System is committed to providing Highly Customized Solutions for all your Development Programs.

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Quotient Sciences- Molecule to Cure. Fast.

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pharmacompass-2-m-2025-08-25

Renedil;Feloday;Plendil

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

33 API Suppliers, 16 USDMF, 10 CEP/COS, 1 JDMF, 4 EU WC, 14 KDMF, 5 NDC API, 10 Listed Suppliers, $ API Reference Price

33 API Suppliers
16 USDMF
10 CEP/COS
1 JDMF
4 EU WC
14 KDMF
5 NDC API
10 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

7 Drugs in Development

7 Drugs in Development

FINISHED DOSAGE FORMULATIONS

204 FDF Dossiers, 44 FDA Orange Book, 96 Europe, 8 Canada, 22 Australia, 7 South Africa, 27 Listed Dossiers

204 FDF Dossiers
44 FDA Orange Book
96 Europe
8 Canada
22 Australia
7 South Africa
27 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TABLET, EXTENDED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 5 DKSH, 1 Boai NKY Pharmaceuticals Ltd, 4 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 1 Kirsch Pharma, 1 ACG Worldwide, 5 Actylis, 3 Aeon Procare, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 21 BASF, 1 CD Formulation, 1 Clariant, 11 Corel Pharma Chem, 5 DFE Pharma, 1 Esteem Industries, 2 Finar, 11 Gangwal Chemicals, 4 Ideal Cures, 2 Ingredion Pharma Solutions, 24 Kerry, 1 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 7 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 3 Pluviaendo, 1 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 15 Roquette, 14 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 9 Sigachi Industries, 1 Silverline Chemicals, 2 The Dow Chemical Company, 2 Valens Pharmachem, 1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

45 Fillers, Diluents & Binders, 41 Coating Systems & Additives, 28 Solubilizers, 28 Direct Compression, 24 Granulation, 23 Thickeners and Stabilizers, 23 Controlled & Modified Release, 19 Topical, 15 Film Formers & Plasticizers, 13 Lubricants & Glidants, 12 Co-Processed Excipients, 12 Parenteral, 10 Disintegrants & Superdisintegrants, 10 Emulsifying Agents, 9 Chewable & Orodispersible Aids, 7 API Stability Enhancers, 7 Taste Masking, 6 Rheology Modifiers, 5 Empty Capsules, 5 Surfactant & Foaming Agents, 4 Vegetarian Capsules, 4 Coloring Agents

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

DIGITAL CONTENT

6 News #PharmaBuzz

6 News #PharmaBuzz

GLOBAL SALES INFORMATION

12 US Medicaid Prescriptions, 75 Regulatory FDF Prices, 3 Annual Reports

12 US Medicaid Prescriptions
75 Regulatory FDF Prices
3 Annual Reports

MARKET PLACE

9 APIs, 2 FDF Dossiers

9 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

8 Health Canada Patents

8 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 2 Others

2 EDQM
2 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 373 Xls

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44 All

01 5ASTRAZENECA

02 3AUROBINDO PHARMA LTD

03 3GLENMARK PHARMS LTD

04 3HERITAGE

05 3JUBILANT GENERICS

06 3MYLAN

07 3ORBION PHARMS

08 3PH HEALTH

09 3SUN PHARM INDS LTD

10 3SUN PHARM INDUSTRIES

11 3TORRENT PHARMS LTD

12 3WOCKHARDT BIO AG

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

List of Suppliers

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01

ASTRAZENECA

iPHEX India

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ASTRAZENECA

iPHEX India

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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 :

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02

ASTRAZENECA

iPHEX India

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ASTRAZENECA

iPHEX India

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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 :

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03

ASTRAZENECA

iPHEX India

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ASTRAZENECA

iPHEX India

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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 :

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04

ASTRAZENECA

iPHEX India

Not Confirmed

ASTRAZENECA

iPHEX India

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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 :

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05

ASTRAZENECA

iPHEX India

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ASTRAZENECA

iPHEX India

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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 :

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06

SUN PHARM INDUSTRIES

iPHEX India

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SUN PHARM INDUSTRIES

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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 :

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07

SUN PHARM INDUSTRIES

iPHEX India

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SUN PHARM INDUSTRIES

iPHEX India

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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 :

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08

SUN PHARM INDUSTRIES

iPHEX India

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SUN PHARM INDUSTRIES

iPHEX India

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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 :

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09

MYLAN

iPHEX India

Not Confirmed

MYLAN

iPHEX India

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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

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10

MYLAN

iPHEX India

Not Confirmed

MYLAN

iPHEX India

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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 :

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