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

Client Email

Product

Nebivolol HCl
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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Nebivolol HCl

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

42 API Suppliers, 15 USDMF, 8 CEP/COS, 7 EU WC, 11 KDMF, 9 NDC API, 29 Listed Suppliers, $ API Reference Price

42 API Suppliers
15 USDMF
8 CEP/COS
7 EU WC
11 KDMF
9 NDC API
29 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

28 API Suppliers

28 API Suppliers

FINISHED DOSAGE FORMULATIONS

263 FDF Dossiers, 72 FDA Orange Book, 109 Europe, 4 Canada, 30 Australia, 2 South Africa, 46 Listed Dossiers

263 FDF Dossiers
72 FDA Orange Book
109 Europe
4 Canada
30 Australia
2 South Africa
46 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 5MG BASE;80MG, TABLET;ORAL - EQ 10MG BASE, TABLET;ORAL - EQ 2.5MG BASE, TABLET;ORAL - EQ 20MG BASE, TABLET;ORAL - EQ 5MG BASE

TABLET;ORAL - EQ 5MG BASE;80MG
TABLET;ORAL - EQ 10MG BASE
TABLET;ORAL - EQ 2.5MG BASE
TABLET;ORAL - EQ 20MG BASE
TABLET;ORAL - EQ 5MG BASE

RELATED EXCIPIENT COMPANIES

4 SPI Pharma, 4 DKSH, 2 Jai Radhe Sales, 2 Boai NKY Pharmaceuticals Ltd, 11 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 2 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 9 BASF, 10 Corel Pharma Chem, 5 DFE Pharma, 10 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 7 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 31 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 1 Nanjing Bold Chemical, 3 Novo Excipients, 1 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 16 Roquette, 13 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 2 The Dow Chemical Company, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

63 Fillers, Diluents & Binders, 52 Coating Systems & Additives, 31 Direct Compression, 26 Controlled & Modified Release, 20 Disintegrants & Superdisintegrants, 18 Granulation, 16 Lubricants & Glidants, 15 Thickeners and Stabilizers, 14 Film Formers & Plasticizers, 14 Co-Processed Excipients, 13 Solubilizers, 10 Taste Masking, 8 Parenteral, 7 Emulsifying Agents, 6 API Stability Enhancers, 6 Topical, 6 Chewable & Orodispersible Aids, 5 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Rheology Modifiers, 3 Surfactant & Foaming Agents

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

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 23 NEWS #PharmaBuzz

2 DATA COMPILATION #PharmaFlow
23 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 102 Finished Drug Prices, 5 Annual Reports

2 US Medicaid Prescriptions
102 Finished Drug Prices
5 Annual Reports

MARKET PLACE

24 APIs, 5 FDF Dossiers, 1 EXCIPIENTS

24 APIs
5 FDF Dossiers
1 EXCIPIENTS

PATENTS & EXCLUSIVITIES

2 US Patents

2 US Patents

REF. STANDARDS & IMPURITIES

6 USP, 6 Others

6 USP
6 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 2,379 Xls

Filters

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15 All

01 1Alkem Laboratories

02 1Cadila Pharmaceuticals

03 1CordenPharma

04 1F.I.S. Fabbrica Italiana Sintetici

05 1HONOUR LAB LTD

06 2Hetero Drugs

07 1Johnson & Johnson Innovative Medicine

08 1MSN Laboratories

09 1Macleods Pharmaceuticals Limited

10 1Nivika Chemo Pharma Pvt. Ltd

11 1Smaart Pharmaceutticals

12 1Torrent Pharmaceuticals Limited

13 1Zhejiang Ausun Pharmaceutical

14 1Zhejiang Huahai Pharmaceutical

filter Subject Reset all filters

15 All

01 1NEBIVOLOL HCI

02 11NEBIVOLOL HYDROCHLORIDE

03 1NEBIVOLOL HYDROCHLORIDE (PROCESS-II)

04 1NEBIVOLOL HYDROCHLORIDE [ROUTE CODE: 'NH']

05 1NEBIVOLOL HYDROCHLORIDE(R067555) DRUG SUBSTANCE AS

filter Country Reset all filters

15 All

01 2China

02 1Germany

03 10India

04 1Italy

05 1U.S.A

filter Status Reset all filters

15 All

01 14Active

02 1Inactive

filter GDUFA DMF Review Reset all filters

15 All

01 10Complete

02 5Blank

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

List of Suppliers

Product Main Page

01

Cadila Pharmaceuticals Ltd

USDMF

Formnext Forum

Not Confirmed

01

Cadila Pharmaceuticals Ltd

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Not Confirmed

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Digital Content

Nebivolol Hydrochloride

GDUFA

DMF Review : Complete

Rev. Date : 2014-03-25

Pay. Date : 2013-09-11

DMF Number : 21152

Submission : 2007-12-08

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Corden Pharma Chenove

USDMF

Formnext Forum

Not Confirmed

02

Corden Pharma Chenove

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Not Confirmed

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Digital Content

Nebivolol Hydrochloride

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 30052

Submission : 2015-12-03

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

03

Fis Fabbrica Italiana Sintetici Spa

USDMF

Formnext Forum

Not Confirmed

03

Fis Fabbrica Italiana Sintetici Spa

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Not Confirmed

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Digital Content

Nebivolol Hydrochloride

GDUFA

DMF Review : Complete

Rev. Date : 2014-10-13

Pay. Date : 2014-10-06

DMF Number : 22735

Submission : 2009-03-31

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Hetero Drugs Ltd

USDMF

Formnext Forum

Not Confirmed

04

Hetero Drugs Ltd

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Digital Content

Nebivolol Hydrochloride

GDUFA

DMF Review : Complete

Rev. Date : 2013-04-04

Pay. Date : 2012-12-05

DMF Number : 25296

Submission : 2011-09-12

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Honour Lab Ltd

USDMF

Formnext Forum

Not Confirmed

05

Honour Lab Ltd

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Digital Content

Nebivolol Hydrochloride

GDUFA

DMF Review : Complete

Rev. Date : 2015-01-05

Pay. Date : 2014-10-07

DMF Number : 28627

Submission : 2014-09-10

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Janssen Pharmaceutica Nv

USDMF

Formnext Forum

Not Confirmed

06

Janssen Pharmaceutica Nv

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Digital Content

Nebivolol Hydrochloride(r067555) Drug Substanc...

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 15417

Submission : 2001-05-07

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Macleods Pharmaceuticals Ltd

USDMF

Formnext Forum

Not Confirmed

07

Macleods Pharmaceuticals Ltd

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Digital Content

Nebivolol Hydrochloride

GDUFA

DMF Review : Complete

Rev. Date : 2016-10-21

Pay. Date : 2016-08-24

DMF Number : 29996

Submission : 2016-02-19

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

08

Msn Pharmachem Private Ltd

USDMF

Formnext Forum

Not Confirmed

08

Msn Pharmachem Private Ltd

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Digital Content

Nebivolol Hydrochloride [route Code: 'nh']

GDUFA

DMF Review : Complete

Rev. Date : 2014-12-01

Pay. Date : 2014-11-20

DMF Number : 24916

Submission : 2011-05-04

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

09

Torrent Pharmaceuticals Ltd

USDMF

Formnext Forum

Not Confirmed

09

Torrent Pharmaceuticals Ltd

Formnext Forum

Not Confirmed

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Digital Content

Nebivolol Hydrochloride

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 22906

Submission : 2009-06-29

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Zhejiang Ausun Pharmaceutical Co Ltd

USDMF

Formnext Forum

Not Confirmed

10

Zhejiang Ausun Pharmaceutical Co Ltd

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.

Post an Enquiry

Post an Enquiry

Digital Content

Nebivolol Hydrochloride

GDUFA

DMF Review : Complete

Rev. Date : 2016-04-13

Pay. Date : 2015-09-21

DMF Number : 29730

Submission : 2015-09-28

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

1
2

Nebivolol HCl Manufacturers | Traders | Suppliers

Nebivolol HCl Manufacturers, Traders, Suppliers 1

68

We have 14 companies offering Nebivolol HCl

Get in contact with the supplier of your choice:

Alkem Laboratories
Cadila Pharmaceuticals
CordenPharma
F.I.S. Fabbrica Italiana Sintetici
Hetero Drugs
HONOUR LAB LTD
Johnson & Johnson Innovative Medicine
Macleods Pharmaceuticals Limited
MSN Laboratories
Nivika Chemo Pharma Pvt. Ltd
Smaart Pharmaceutticals
Torrent Pharmaceuticals Limited
Zhejiang Ausun Pharmaceutical
Zhejiang Huahai Pharmaceutical

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