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Labetalol HCl

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ACTIVE PHARMA INGREDIENTS

34 API Suppliers, 18 USDMF, 7 CEP/COS, 4 JDMF, 4 EU WC, 12 NDC API, 15 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

INTERMEDIATES

10 Intermediate Suppliers

10 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

130 FDF Dossiers, 78 FDA Orange Book, 12 Europe, 11 Canada, 2 Australia, 2 South Africa, 25 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

4 SPI Pharma, 5 DKSH, 3 Faran Shimi Pharmaceutical, 4 Boai NKY Pharmaceuticals Ltd, 4 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 17 BASF, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 1 Finar, 12 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 38 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 12 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 3 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 17 Roquette, 13 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

60 Fillers, Diluents & Binders, 51 Coating Systems & Additives, 29 Disintegrants & Superdisintegrants, 27 Direct Compression, 27 Controlled & Modified Release, 25 Thickeners and Stabilizers, 20 Granulation, 18 Solubilizers, 14 Lubricants & Glidants, 13 Topical, 12 Film Formers & Plasticizers, 12 Co-Processed Excipients, 9 Chewable & Orodispersible Aids, 9 Parenteral, 7 Taste Masking, 7 Emulsifying Agents, 6 API Stability Enhancers, 6 Rheology Modifiers, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Coloring Agents, 3 Surfactant & Foaming Agents

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 18 News #PharmaBuzz

GLOBAL SALES INFORMATION

12 Regulatory FDF Prices

12 Regulatory FDF Prices

MARKET PLACE

23 APIs, 11 FDF Dossiers

REF. STANDARDS & IMPURITIES

3 EDQM, 1 USP, 2 Others

$ Xls download

Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/03/2025	Neuland Laboratories	India	NEULAND LABORATORIES LTD	30564	LABETALOL HYDROCHLORIDE USP	2016-06-07	Active	II	Complete	2017-01-31	2017-01-11
28/03/2025	TAPI Technology & API Services	Israel	FLAMMA SPA	16314	LABETALOL HYDROCHLORIDE	2002-12-17	Active	II	Complete	2014-03-06	2014-03-04

Labetalol HCl

Labetalol HCl

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

34 API Suppliers

18 USDMF

7 CEP/COS

4 JDMF

4 EU WC

12 NDC API

15 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

INTERMEDIATES

10 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

130 FDF Dossiers

78 FDA Orange Book

12 Europe

11 Canada

2 Australia

2 South Africa

25 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

4 SPI Pharma

5 DKSH

3 Faran Shimi Pharmaceutical

4 Boai NKY Pharmaceuticals Ltd

4 Gangwal Healthcare

4 Nanjing Well Pharmaceutical

1 ACG Worldwide

5 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

17 BASF

1 Clariant

10 Corel Pharma Chem

6 DFE Pharma

1 Finar

12 Gangwal Chemicals

7 Ideal Cures Pvt Ltd

3 Ingredion Pharma Solutions

38 Kerry

3 Kima Chemical

6 Lonza Capsugel

12 Microlex e.U

1 Nanjing Bold Chemical

2 Nomisma Healthcare

3 Novo Excipients

3 Pharmatrans-Sanaq

3 Pluviaendo

3 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

17 Roquette

13 Seppic

4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

11 Sigachi Industries

2 The Dow Chemical Company

1 Ulanqab Kema New Material

3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

60 Fillers, Diluents & Binders

51 Coating Systems & Additives

29 Disintegrants & Superdisintegrants

27 Direct Compression

27 Controlled & Modified Release

25 Thickeners and Stabilizers

20 Granulation

18 Solubilizers

TABLET;ORAL - 100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons