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List of Drug Master Files (DMF) of Prestwick3_000279 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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Product

Prestwick3_000279
USDMF

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Prestwick3_000279

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

26 API Suppliers, 15 USDMF, 8 CEP/COS, 2 EU WC, 13 KDMF, 10 NDC API, 14 Listed Suppliers, $ API Reference Price

26 API Suppliers
15 USDMF
8 CEP/COS
2 EU WC
13 KDMF
10 NDC API
14 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

10 Drugs in Development

10 Drugs in Development

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

244 FDF Dossiers, 38 FDA Orange Book, 102 Europe, 7 Canada, 55 Australia, 19 South Africa, 23 Listed Dossiers

244 FDF Dossiers
38 FDA Orange Book
102 Europe
7 Canada
55 Australia
19 South Africa
23 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 16MG, TABLET;ORAL - 2MG, TABLET;ORAL - 32MG, TABLET;ORAL - 4MG, TABLET;ORAL - 8MG

TABLET;ORAL - 16MG
TABLET;ORAL - 2MG
TABLET;ORAL - 32MG
TABLET;ORAL - 4MG
TABLET;ORAL - 8MG

RELATED EXCIPIENT COMPANIES

4 SPI Pharma, 1 DKSH, 1 Jai Radhe Sales, 12 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 Actylis, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 9 BASF, 1 Corel Pharma Chem, 7 DFE Pharma, 1 Doshion Polyscience, 5 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 26 Kerry, 14 Microlex e.U, 2 Pharmatrans-Sanaq, 5 Pluviaendo, 4 Prachin Chemical, 20 Roquette, 1 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 1 Valens Pharmachem, 5 Vasa Pharmachem

4 SPI Pharma
1 DKSH
1 Jai Radhe Sales
12 Gangwal Healthcare
1 Nanjing Well Pharmaceutical
1 Pfanstiehl
1 Actylis
7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
9 BASF
1 Corel Pharma Chem
7 DFE Pharma
1 Doshion Polyscience
5 Gangwal Chemicals
1 Ideal Cures Pvt Ltd
4 Ingredion Pharma Solutions
26 Kerry
14 Microlex e.U
2 Pharmatrans-Sanaq
5 Pluviaendo
4 Prachin Chemical
20 Roquette
1 Seppic
6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
11 Sigachi Industries
1 Valens Pharmachem
5 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

59 Fillers, Diluents & Binders, 32 Direct Compression, 30 Disintegrants & Superdisintegrants, 21 Lubricants & Glidants, 20 Granulation, 16 Thickeners and Stabilizers, 15 Co-Processed Excipients, 12 Coating Systems & Additives, 12 Taste Masking, 7 Controlled & Modified Release, 5 Film Formers & Plasticizers, 5 Chewable & Orodispersible Aids, 3 Emulsifying Agents, 2 Parenteral, 2 Topical, 2 Rheology Modifiers, 1 API Stability Enhancers, 1 Solubilizers, 1 Surfactant & Foaming Agents

59 Fillers, Diluents & Binders
32 Direct Compression
30 Disintegrants & Superdisintegrants
21 Lubricants & Glidants
20 Granulation
16 Thickeners and Stabilizers
15 Co-Processed Excipients
12 Coating Systems & Additives
12 Taste Masking
7 Controlled & Modified Release
5 Film Formers & Plasticizers
5 Chewable & Orodispersible Aids
3 Emulsifying Agents
2 Parenteral
2 Topical
2 Rheology Modifiers
1 API Stability Enhancers
1 Solubilizers
1 Surfactant & Foaming Agents

DIGITAL CONTENT

23 NEWS #PharmaBuzz

23 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 74 Finished Drug Prices, 10 Annual Reports

3 US Medicaid Prescriptions
74 Finished Drug Prices
10 Annual Reports

MARKET PLACE

17 APIs, 31 FDF Dossiers

17 APIs
31 FDF Dossiers

REF. STANDARDS & IMPURITIES

5 EDQM, 3 USP, 3 Others

5 EDQM
3 USP
3 Others

$ API Ref.Price (USD/KG) : 1,784 Xls

Filters

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15 All

01 2Symbiotec Pharmalab

02 1EUROAPI

03 1Bayer AG

04 2Fujifilm Diosynth Biotechnologies

05 1Henan Lihua Pharmaceutical

06 1Laboratorio Syntex S.A

07 2Pfizer Inc

08 1Quimica Sintetica

09 1SIMS Srl

10 2Tianjin Tianyao Pharmaceuticals Co., Ltd.

11 1Zhejiang Xianju Pharmaceutical Co. Ltd

filter Subject Reset all filters

15 All

01 1(VET) 6-ALPHA-9-A-DIFLUORO-16-A-METHYL PREDNISOLONE DESIGNATED RS 2177

02 16-ALPHA METHYLPREDNISOLONE

03 16-METHYLPREDNISOLNE

04 16a-METHYLPREDNISOLONE

05 3METHYLPREDNISOLONE

06 1METHYLPREDNISOLONE 100MG TABLETS

07 2METHYLPREDNISOLONE USP

08 1METHYLPREDNISOLONE USP (PROCESS 2)

09 1METHYLPREDNISOLONE USP KALAMAZOO

10 1METHYLPREDNISOLONE USP, NON-STERILE BULK DRUG SUBSTANCE

11 1METHYLPREDNISOLONE, USP

12 1METHYLPREDNISOLONE, USP (MICRONIZED)

filter Country Reset all filters

15 All

01 1Argentina

02 4China

03 1France

04 1Germany

05 2India

06 1Italy

07 1Spain

08 2U.S.A

09 2United Kingdom

filter Status Reset all filters

15 All

01 8Active

02 7Inactive

filter GDUFA DMF Review Reset all filters

15 All

01 4Complete

02 11Blank

Humanwell Methylprednisolone

API Suppliers
USDMF
CEP/COS
EU WC
KDMF
NDC API
Listed Suppliers

List of Suppliers

Product Main Page

01

Symbiotec Pharmalab Private Ltd

CPhI Worldwide, Milan

Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

Contact Supplier

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Digital Content

Methylprednisolone, Usp (micronized)

GDUFA

DMF Review : Complete

Rev. Date : 2014-07-21

Pay. Date : 2013-12-17

DMF Number : 27783

Submission : 2013-11-25

Status : Active

Type : II

Symbiotec Pharmalab

Product Web Link

Digital Content

Corporate PDF

02

Euroapi France

CPhI Worldwide, Milan

EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

Contact Supplier

Contact Supplier

Digital Content

Methylprednisolone

GDUFA

DMF Review : Complete

Rev. Date : 2014-10-01

Pay. Date : 2013-12-10

DMF Number : 3771

Submission : 1980-04-15

Status : Active

Type : II

EUROAPI Compnay Banner

Product Web Link

Digital Content

03

Symbiotec Pharmalab Private Ltd

CPhI Worldwide, Milan

Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

Contact Supplier

Contact Supplier

Digital Content

Methylprednisolone Usp (process 2)

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 34637

Submission : 2020-11-05

Status : Active

Type : II

Symbiotec Pharmalab

Product Web Link

Digital Content

Corporate PDF

04

Diosynth Bv

USDMF

Formnext Forum

Not Confirmed

04

Diosynth Bv

Formnext Forum

Not Confirmed

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Digital Content

Methylprednisolone

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 3592

Submission : 1979-08-06

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Henan Lihua Pharmaceutical Co Ltd

USDMF

Formnext Forum

Not Confirmed

05

Henan Lihua Pharmaceutical Co Ltd

Formnext Forum

Not Confirmed

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Digital Content

Methylprednisolone Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 31630

Submission : 2017-04-28

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Syntex Laboratories Inc Sub Syntex C...

USDMF

Formnext Forum

Not Confirmed

06

Syntex Laboratories Inc Sub Syntex C...

Formnext Forum

Not Confirmed

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Digital Content

(vet) 6-alpha-9-a-difluoro-16-a-methyl Prednis...

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 601

Submission : 1963-06-27

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

07

Pharmacia And Upjohn Sub Pfizer Inc

USDMF

Formnext Forum

Not Confirmed

07

Pharmacia And Upjohn Sub Pfizer Inc

Formnext Forum

Not Confirmed

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Digital Content

Methylprednisolone Usp Kalamazoo

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 4796

Submission : 1983-01-06

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

08

Tianjin Tianyao Pharmaceuticals Co L...

USDMF

Formnext Forum

Not Confirmed

08

Tianjin Tianyao Pharmaceuticals Co L...

Formnext Forum

Not Confirmed

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Digital Content

Methylprednisolone, Usp

GDUFA

DMF Review : Complete

Rev. Date : 2014-06-05

Pay. Date : 2013-09-16

DMF Number : 26458

Submission : 2012-09-18

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Tianjin Tianyao Pharmaceuticals Co L...

USDMF

Formnext Forum

Not Confirmed

09

Tianjin Tianyao Pharmaceuticals Co L...

Formnext Forum

Not Confirmed

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Digital Content

Methylprednisolone Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 17547

Submission : 2004-07-19

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Zhejiang Xianju Pharmaceutical Co Lt...

USDMF

Formnext Forum

Not Confirmed

10

Zhejiang Xianju Pharmaceutical Co Lt...

Formnext Forum

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

Methylprednisolone Usp, Non-sterile Bulk Drug ...

GDUFA

DMF Review : Complete

Rev. Date : 2020-03-02

Pay. Date : 2020-02-26

DMF Number : 25067

Submission : 2011-06-18

Status : Active

Type : II

Product Web Link

Digital Content

1
2

Prestwick3_000279 Manufacturers | Traders | Suppliers

Prestwick3_000279 Manufacturers, Traders, Suppliers 1

41

We have 11 companies offering Prestwick3_000279

Get in contact with the supplier of your choice:

EUROAPI
Symbiotec Pharmalab
Bayer AG
Fujifilm Diosynth Biotechnologies
Henan Lihua Pharmaceutical
Laboratorio Syntex S.A
Pfizer Inc
Quimica Sintetica
SIMS Srl
Tianjin Tianyao Pharmaceuticals Co., Ltd.
Zhejiang Xianju Pharmaceutical Co. Ltd

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