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List of Drug Master Files (DMF) of Prestwick3_000358 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

Client Email

Product

Prestwick3_000358
USDMF

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_000358

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

27 API Suppliers, 21 USDMF, 4 JDMF, 1 EU WC, 5 NDC API, 4 Listed Suppliers, $ API Reference Price

27 API Suppliers
21 USDMF
4 JDMF
1 EU WC
5 NDC API
4 Listed Suppliers
$ API Reference Price

PRICE INFORMATION

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

API Reference Price
API Exports
API Imports
FDF Exports
FDF Imports

INTERMEDIATES

3 API Suppliers

3 API Suppliers

FINISHED DOSAGE FORMULATIONS

157 FDF Dossiers, 93 FDA Orange Book, 6 Europe, 6 Canada, 2 South Africa, 50 Listed Dossiers

157 FDF Dossiers
93 FDA Orange Book
6 Europe
6 Canada
2 South Africa
50 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - EQ 333MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE;ORAL - EQ 333MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE;ORAL - EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE;ORAL - EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

4 Rochem International Inc, 6 SPI Pharma, 12 DKSH, 2 Jai Radhe Sales, 1 Pharm-RX Chemical, 12 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 6 Actylis, 1 Aeon Procare, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 9 BASF, 1 Clariant, 7 DFE Pharma, 2 Finar, 9 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 26 Kerry, 1 Kima Chemical, 3 Lonza Capsugel, 13 Microlex e.U, 1 Nanjing Bold Chemical, 2 Pharmatrans-Sanaq, 6 Pluviaendo, 4 Prachin Chemical, 1 Qualicaps, 23 Roquette, 8 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 12 Sigachi Industries, 1 The Dow Chemical Company, 1 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

67 Fillers, Diluents & Binders, 33 Thickeners and Stabilizers, 33 Direct Compression, 28 Disintegrants & Superdisintegrants, 19 Granulation, 18 Solubilizers, 17 Coating Systems & Additives, 16 Lubricants & Glidants, 16 Co-Processed Excipients, 14 Taste Masking, 13 Topical, 10 Parenteral, 10 Film Formers & Plasticizers, 9 Rheology Modifiers, 8 Controlled & Modified Release, 8 Empty Capsules, 7 Emulsifying Agents, 6 Chewable & Orodispersible Aids, 4 Surfactant & Foaming Agents, 3 API Stability Enhancers, 3 Coloring Agents

67 Fillers, Diluents & Binders
33 Thickeners and Stabilizers
33 Direct Compression
28 Disintegrants & Superdisintegrants
19 Granulation
18 Solubilizers
17 Coating Systems & Additives
16 Lubricants & Glidants
16 Co-Processed Excipients
14 Taste Masking
13 Topical
10 Parenteral
10 Film Formers & Plasticizers
9 Rheology Modifiers
8 Controlled & Modified Release
8 Empty Capsules
7 Emulsifying Agents
6 Chewable & Orodispersible Aids
4 Surfactant & Foaming Agents
3 API Stability Enhancers
3 Coloring Agents

DIGITAL CONTENT

4 DATA COMPILATION #PharmaFlow, 16 NEWS #PharmaBuzz

4 DATA COMPILATION #PharmaFlow
16 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 12 Finished Drug Prices

1 US Medicaid Prescriptions
12 Finished Drug Prices

MARKET PLACE

14 APIs, 4 FDF Dossiers

14 APIs
4 FDF Dossiers

REF. STANDARDS & IMPURITIES

2 USP, 10 Others

2 USP
10 Others

$ API Ref.Price (USD/KG) : 63 Xls

Filters

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21 All

01 2Aurobindo Pharma Limited

02 2Bristol Myers Squibb

03 1Elanco

04 1Eli Lilly

05 1GSK

06 2Lupin Ltd

07 1Orchid Pharma

08 1RANBAXY LABORATORIES LIMITED

09 1Shionogi

10 1Sun Pharmaceutical Industries Limited

11 1Taiwan Biotech

12 1Teva API

13 1Unimark Remedies Limited

14 1Yung Shin Pharmaceutical Industrial

15 4Blank

filter Subject Reset all filters

21 All

01 10CEPHALEXIN

02 1CEPHALEXIN DISOLVATE

03 6CEPHALEXIN USP

04 1CEPHALEXIN USP "YUNG SHIN"

05 1CEPHALEXIN USP (COMPACTED)

06 1CEPHALEXIN USP (ENZYMATIC ROUTE)

07 1KEFLEX R SUSTAINED RELEASE CAPSULES (CEPHALEXIN MONOHYDRATE LILLY)

filter Country Reset all filters

21 All

01 2China

02 8India

03 1Israel

04 1Japan

05 4U.S.A

06 1United Kingdom

07 4Blank

filter Status Reset all filters

21 All

01 5Active

02 16Inactive

filter GDUFA DMF Review Reset all filters

21 All

01 1Complete

02 20Blank

API Suppliers
USDMF
JDMF
EU WC
NDC API
Listed Suppliers

List of Suppliers

Product Main Page

01

Apitoria Pharma Private Ltd

USDMF

AAPS 2024

Not Confirmed

01

Apitoria Pharma Private Ltd

AAPS 2024

Not Confirmed

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Digital Content

Cephalexin Usp (enzymatic Route)

GDUFA

DMF Review : Complete

Rev. Date : 2019-05-07

Pay. Date : 2019-03-29

DMF Number : 32930

Submission : 2019-03-29

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

02

Apitoria Pharma Private Ltd

USDMF

AAPS 2024

Not Confirmed

02

Apitoria Pharma Private Ltd

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

Cephalexin Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 17604

Submission : 2004-07-31

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

03

Elanco Quimica Limitada

USDMF

AAPS 2024

Not Confirmed

03

Elanco Quimica Limitada

AAPS 2024

Not Confirmed

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Digital Content

Cephalexin Disolvate

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 9889

Submission : 1992-09-21

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Dista Products Co Div Eli Lilly And ...

USDMF

AAPS 2024

Not Confirmed

04

Dista Products Co Div Eli Lilly And ...

AAPS 2024

Not Confirmed

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Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 13610

Submission : 1998-09-01

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

05

Glaxo Laboratories Sa

USDMF

AAPS 2024

Not Confirmed

05

Glaxo Laboratories Sa

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

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 1820

Submission : 1971-11-10

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Lupin Ltd

USDMF

AAPS 2024

Not Confirmed

06

Lupin Ltd

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

Cephalexin Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 17277

Submission : 2004-03-24

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

07

Orchid Pharma Ltd

USDMF

AAPS 2024

Not Confirmed

07

Orchid Pharma Ltd

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

Cephalexin Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 15106

Submission : 2000-10-18

Status : Active

Type : II

Product Web Link

Digital Content

08

Shionogi And Co Ltd

USDMF

AAPS 2024

Not Confirmed

08

Shionogi And Co Ltd

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

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Digital Content

Keflex R Sustained Release Capsules (cephalexi...

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 3118

Submission : 1977-11-17

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Teva Pharmaceutical Industries Ltd

USDMF

AAPS 2024

Not Confirmed

09

Teva Pharmaceutical Industries Ltd

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

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 13719

Submission : 1998-09-01

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

10

Yoshitomi Pharmaceutical Industries ...

Country

USDMF

AAPS 2024

Not Confirmed

10

Yoshitomi Pharmaceutical Industries ...

Country

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

Country

Virtual Booth

Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 13715

Submission : 1998-09-01

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

1
2
3

Prestwick3_000358 Manufacturers | Traders | Suppliers

Prestwick3_000358 Manufacturers, Traders, Suppliers 1

21

We have 14 companies offering Prestwick3_000358

Get in contact with the supplier of your choice:

Aurobindo Pharma Limited
Bristol Myers Squibb
Elanco
Eli Lilly
GSK
Lupin Ltd
Orchid Pharma
RANBAXY LABORATORIES LIMITED
Shionogi
Sun Pharmaceutical Industries Limited
Taiwan Biotech
Teva API
Unimark Remedies Limited
Yung Shin Pharmaceutical Industrial

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