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Approved Drug Products containing Prestwick3_001044 listed in the FDA Orange Book. Original Data : FDA Website

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Product

Prestwick3_001044
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_001044

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

8 API Suppliers, 2 USDMF, 2 CEP/COS, 1 KDMF, 4 NDC API, 7 Listed Suppliers

8 API Suppliers
2 USDMF
2 CEP/COS
1 KDMF
4 NDC API
7 Listed Suppliers

FINISHED DOSAGE FORMULATIONS

29 FDF Dossiers, 4 FDA Orange Book, 21 Europe, 1 Canada, 3 Listed Dossiers

29 FDF Dossiers
4 FDA Orange Book
21 Europe
1 Canada
3 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

OINTMENT;TOPICAL - 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CREAM;TOPICAL - 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

OINTMENT;TOPICAL - 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CREAM;TOPICAL - 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 DKSH, 1 Pharm-RX Chemical, 1 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 8 BASF, 1 Finar, 5 Microlex e.U, 1 Pluviaendo, 1 Prachin Chemical, 1 Seppic, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Valens Pharmachem, 1 Vasa Pharmachem

1 Minakem
1 DKSH
1 Pharm-RX Chemical
1 Gangwal Healthcare
3 Nanjing Well Pharmaceutical
1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
8 BASF
1 Finar
5 Microlex e.U
1 Pluviaendo
1 Prachin Chemical
1 Seppic
1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Valens Pharmachem
1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

13 Topical, 8 Lubricants & Glidants, 5 Fillers, Diluents & Binders, 4 Emulsifying Agents, 4 Thickeners and Stabilizers, 3 Solubilizers, 2 API Stability Enhancers, 2 Parenteral, 2 Film Formers & Plasticizers, 1 Co-Processed Excipients, 1 Direct Compression, 1 Surfactant & Foaming Agents, 1 Controlled & Modified Release

13 Topical
8 Lubricants & Glidants
5 Fillers, Diluents & Binders
4 Emulsifying Agents
4 Thickeners and Stabilizers
3 Solubilizers
2 API Stability Enhancers
2 Parenteral
2 Film Formers & Plasticizers
1 Co-Processed Excipients
1 Direct Compression
1 Surfactant & Foaming Agents
1 Controlled & Modified Release

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 21 Finished Drug Prices

1 US Medicaid Prescriptions
21 Finished Drug Prices

MARKET PLACE

1 APIs

1 APIs

REF. STANDARDS & IMPURITIES

2 EDQM, 4 USP, 4 Others

2 EDQM
4 USP
4 Others

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4 All

01 2FOUGERA PHARMS

02 1VALEANT BERMUDA

03 1VALEANT PHARMS NORTH

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4 All

01 2CREAM;TOPICAL

02 2OINTMENT;TOPICAL

filter Regulatory Info Reset all filters

4 All

01 3DISCN

02 1RX

filter Brand Name Reset all filters

4 All

01 1DERMATOP

02 1DERMATOP E EMOLLIENT

03 2PREDNICARBATE

filter RLD Reset all filters

4 All

01 2No

02 2Yes

FDF Dossiers
FDA Orange Book
Europe
Canada
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01

VALEANT PHARMS NORTH

AAPS 2024

Not Confirmed

VALEANT PHARMS NORTH

AAPS 2024

Not Confirmed

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RLD : Yes

TE Code :

PREDNICARBATE

Brand Name : DERMATOP

Dosage Form : OINTMENT;TOPICAL

Dosage Strength : 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1991-09-23

Application Number : 19568

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

VALEANT BERMUDA

AAPS 2024

Not Confirmed

VALEANT BERMUDA

AAPS 2024

Not Confirmed

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RLD : Yes

TE Code :

PREDNICARBATE

Brand Name : DERMATOP E EMOLLIENT

Dosage Form : CREAM;TOPICAL

Dosage Strength : 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1993-10-29

Application Number : 20279

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

FOUGERA PHARMS

U.S.A

AAPS 2024

Not Confirmed

FOUGERA PHARMS

U.S.A

AAPS 2024

Not Confirmed

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U.S.A

Digital Content

RLD : No

TE Code :

PREDNICARBATE

Brand Name : PREDNICARBATE

Dosage Form : OINTMENT;TOPICAL

Dosage Strength : 0.1%

Approval Date : 2007-03-09

Application Number : 77236

RX/OTC/DISCN : RX

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Website

Corporate PDF

04

FOUGERA PHARMS

U.S.A

AAPS 2024

Not Confirmed

FOUGERA PHARMS

U.S.A

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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U.S.A

Digital Content

RLD : No

TE Code :

PREDNICARBATE

Brand Name : PREDNICARBATE

Dosage Form : CREAM;TOPICAL

Dosage Strength : 0.1%

Approval Date : 2006-09-19

Application Number : 77287

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Website

Corporate PDF

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