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List of Drug Master Files (DMF) of NCGC00024983-01 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

Client Email

Product

NCGC00024983-01
USDMF

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

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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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xyz-pharma-m-2024-09-09

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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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xyz-pharma-m-2024-09-09

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NCGC00024983-01

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

58 API Suppliers, 38 USDMF, 9 CEP/COS, 7 JDMF, 4 EU WC, 7 KDMF, 19 NDC API, 18 Listed Suppliers, $ API Reference Price

58 API Suppliers
38 USDMF
9 CEP/COS
7 JDMF
4 EU WC
7 KDMF
19 NDC API
18 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

273 FDF Dossiers, 75 FDA Orange Book, 100 Europe, 18 Canada, 8 Australia, 32 South Africa, 40 Listed Dossiers

273 FDF Dossiers
75 FDA Orange Book
100 Europe
18 Canada
8 Australia
32 South Africa
40 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 10MG, CAPSULE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 30MG, TABLET, EXTENDED RELEASE;ORAL - 60MG, TABLET, EXTENDED RELEASE;ORAL - 90MG, TABLET, EXTENDED RELEASE;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE;ORAL - 10MG
CAPSULE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 30MG
TABLET, EXTENDED RELEASE;ORAL - 60MG
TABLET, EXTENDED RELEASE;ORAL - 90MG
TABLET, EXTENDED RELEASE;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Evonik, 2 Rochem International Inc, 6 SPI Pharma, 2 Seqens, 12 DKSH, 4 Boai NKY Pharmaceuticals Ltd, 12 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 4 ACG Worldwide, 8 Actylis, 1 Aeon Procare, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 26 BASF, 1 Clariant, 12 Corel Pharma Chem, 5 DFE Pharma, 3 Doshion Polyscience, 3 Finar, 8 Gangwal Chemicals, 11 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 39 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 2 Nomisma Healthcare, 3 Novo Excipients, 2 Pharmatrans-Sanaq, 7 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 24 Roquette, 10 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 2 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

81 Fillers, Diluents & Binders, 63 Coating Systems & Additives, 40 Controlled & Modified Release, 33 Direct Compression, 28 Thickeners and Stabilizers, 23 Film Formers & Plasticizers, 23 Granulation, 21 Parenteral, 21 Solubilizers, 20 Topical, 20 Taste Masking, 19 Co-Processed Excipients, 17 Lubricants & Glidants, 13 Disintegrants & Superdisintegrants, 9 Empty Capsules, 8 Chewable & Orodispersible Aids, 7 Emulsifying Agents, 6 Rheology Modifiers, 6 API Stability Enhancers, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 1 Soft Gelatin

81 Fillers, Diluents & Binders
63 Coating Systems & Additives
40 Controlled & Modified Release
33 Direct Compression
28 Thickeners and Stabilizers
23 Film Formers & Plasticizers
23 Granulation
21 Parenteral
21 Solubilizers
20 Topical
20 Taste Masking
19 Co-Processed Excipients
17 Lubricants & Glidants
13 Disintegrants & Superdisintegrants
9 Empty Capsules
8 Chewable & Orodispersible Aids
7 Emulsifying Agents
6 Rheology Modifiers
6 API Stability Enhancers
5 Coloring Agents
4 Vegetarian Capsules
4 Surfactant & Foaming Agents
1 Soft Gelatin

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 18 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
18 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 106 Finished Drug Prices, 10 Annual Reports

2 US Medicaid Prescriptions
106 Finished Drug Prices
10 Annual Reports

MARKET PLACE

20 APIs, 16 FDF Dossiers

20 APIs
16 FDF Dossiers

PATENTS & EXCLUSIVITIES

4 Health Canada Patents

4 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 3 USP, 15 Others

3 EDQM
3 USP
15 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 81 Xls

Filters

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Filters

FILTER :

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38 All

01 1Moehs Iberica

02 2Bayer AG

03 1Cadila Pharmaceuticals

04 2Catalent Pharma Solutions

05 1China Chemical & Pharmaceutical

06 1Cipla

07 1Dipharma

08 1F.I.S. Fabbrica Italiana Sintetici

09 2J.B.Chemicals & Pharmaceuticals

10 1Kremers Urban Pharmaceuticals

11 1Krka

12 1Lek Pharmaceuticals

13 1Lusochimica

14 1NORDIC SYNTHESIS AB

15 1PROMETIC BIOSCIENCES LTD

16 6RP SCHERER GMBH & CO. KG

17 1Sharon Bio-Medicine Limited

18 1Shilpa Medicare

19 1Siegfried AG

20 1Teva API

21 1Unichem Laboratories Limited

22 9Blank

filter Subject Reset all filters

38 All

01 16NIFEDIPINE

02 1NIFEDIPINE (10MG AND 20MG) SOFTGEL CAPSULE

03 1NIFEDIPINE 50 MG. TABLETS

04 1NIFEDIPINE BULK DRUG SUBSTANCE

05 1NIFEDIPINE DRUG SUBSTANCE

06 2NIFEDIPINE SOFTGELS 10 MG

07 1NIFEDIPINE SOFTGELS 10 MG, TO SUPPORT CHELSEA LABS. ANDA

08 1NIFEDIPINE SOFTGELS 20 MG

09 1NIFEDIPINE SOFTGELS 20 MG, KALIPHARMA, INC.

10 1NIFEDIPINE SOFTGELS 20 MG, TO SUPPORT CHELSEA LABS. ANDA

11 5NIFEDIPINE USP

12 1NIFEDIPINE USP XX

13 1NIFEDIPINE USP XXI

14 1NIFEDIPINE USP, (BULK ACTIVE PHARMACEUTICAL INGREDIENT), MANFACTURED IN TAIWAN, THE REPUBLIC OF CHINA

15 1NIFEDIPINE-USP

16 1PROCARDIA SOFTGELS 10 MG (NIFEDIPINE)

17 1PRODUCTION AND CONTROL METHODS FOR THE

18 1PRODUCTION AND CONTROL METHODS FOR THE MFG. OF NIFEDIPINE

filter Country Reset all filters

38 All

01 1Canada

02 1China

03 8Germany

04 7India

05 1Israel

06 3Italy

07 2Slovenia

08 1Spain

09 1Sweden

10 1Switzerland

11 3U.S.A

12 9Blank

filter Status Reset all filters

38 All

01 9Active

02 29Inactive

filter GDUFA DMF Review Reset all filters

38 All

01 7Complete

02 31Blank

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

List of Suppliers

Product Main Page

01

Moehs Iberica Sl

CPhI Worldwide, Milan

Moehs Group, a reference company in the production of pharmaceutical active ingredients.

Contact Supplier

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Digital Content

GDUFA

DMF Review : Complete

Rev. Date : 2013-04-02

Pay. Date : 2013-03-25

DMF Number : 7504

Submission : 1988-06-03

Status : Active

Type : II

Product Web Link

Digital Content

02

Bayer Healthcare Ag

USDMF

Formnext Forum

Not Confirmed

02

Bayer Healthcare Ag

Formnext Forum

Not Confirmed

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Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 3672

Submission : 1979-12-26

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Dipharma Francis Srl

USDMF

Formnext Forum

Not Confirmed

03

Dipharma Francis Srl

Formnext Forum

Not Confirmed

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Digital Content

Nifedipine Usp

GDUFA

DMF Review : Complete

Rev. Date : 2016-03-25

Pay. Date : 2016-02-25

DMF Number : 6505

Submission : 1986-07-23

Status : Active

Type : II

Product Web Link

Digital Content

04

Fis Fabbrica Italiana Sintetici Spa

USDMF

Formnext Forum

Not Confirmed

04

Fis Fabbrica Italiana Sintetici Spa

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Digital Content

Nifedipine Usp

GDUFA

DMF Review : Complete

Rev. Date : 2013-03-15

Pay. Date : 2013-02-27

DMF Number : 6339

Submission : 1986-03-14

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Unique Chemicals (a Div Of J B Chemi...

USDMF

Formnext Forum

Not Confirmed

05

Unique Chemicals (a Div Of J B Chemi...

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Not Confirmed

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Digital Content

Nifedipine Usp

GDUFA

DMF Review : Complete

Rev. Date : 2015-01-24

Pay. Date : 2015-01-07

DMF Number : 16730

Submission : 2003-07-29

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Eirchem Pharma Services Ltd

USDMF

Formnext Forum

Not Confirmed

06

Eirchem Pharma Services Ltd

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Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 29497

Submission : 2015-09-04

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Sharon Bio Medicine Ltd

USDMF

Formnext Forum

Not Confirmed

07

Sharon Bio Medicine Ltd

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Digital Content

Nifedipine Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 25557

Submission : 2011-12-05

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Shilpa Pharma Lifesciences Ltd

USDMF

Formnext Forum

Not Confirmed

08

Shilpa Pharma Lifesciences Ltd

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Digital Content

Nifedipine-usp

GDUFA

DMF Review : Complete

Rev. Date : 2021-11-04

Pay. Date : 2021-09-21

DMF Number : 36235

Submission : 2021-09-11

Status : Active

Type : II

Product Web Link

Digital Content

09

Teva Pharmaceutical Industries Ltd

USDMF

Formnext Forum

Not Confirmed

09

Teva Pharmaceutical Industries Ltd

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Digital Content

GDUFA

DMF Review : Complete

Rev. Date : 2012-11-30

Pay. Date : 2012-11-09

DMF Number : 6197

Submission : 1985-12-03

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

10

Unichem Laboratories Ltd

USDMF

Formnext Forum

Not Confirmed

10

Unichem Laboratories Ltd

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Digital Content

Nifedipine Usp

GDUFA

DMF Review : Complete

Rev. Date : 2019-03-01

Pay. Date : 2018-12-20

DMF Number : 33562

Submission : 2019-02-07

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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NCGC00024983-01 Manufacturers | Traders | Suppliers

NCGC00024983-01 Manufacturers, Traders, Suppliers 1

76

We have 21 companies offering NCGC00024983-01

Get in contact with the supplier of your choice:

Moehs Iberica
Bayer AG
Cadila Pharmaceuticals
Catalent Pharma Solutions
China Chemical & Pharmaceutical
Cipla
Dipharma
F.I.S. Fabbrica Italiana Sintetici
J.B.Chemicals & Pharmaceuticals
Kremers Urban Pharmaceuticals
Krka
Lek Pharmaceuticals
Lusochimica
NORDIC SYNTHESIS AB
PROMETIC BIOSCIENCES LTD
RP SCHERER GMBH & CO. KG
Sharon Bio-Medicine Limited
Shilpa Medicare
Siegfried AG
Teva API
Unichem Laboratories Limited

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