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Approved Drug Products containing Labetalol Hydrochloride listed with Health Canada. Original Data : Health Canada Website

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Product

Labetalol Hydrochloride
Canada

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

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Bora Pharmaceuticals- Making success more certain.

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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

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Axplora- The partner of choice for complex APIs.

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Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

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Labetalol Hydrochloride

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

32 API Suppliers, 19 USDMF, 6 CEP/COS, 4 JDMF, 4 EU WC, 13 NDC API, 16 Listed Suppliers, $ API Reference Price

32 API Suppliers
19 USDMF
6 CEP/COS
4 JDMF
4 EU WC
13 NDC API
16 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

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

10 API Suppliers

10 API Suppliers

FINISHED DOSAGE FORMULATIONS

128 FDF Dossiers, 77 FDA Orange Book, 12 Europe, 11 Canada, 2 Australia, 2 South Africa, 24 Listed Dossiers

128 FDF Dossiers
77 FDA Orange Book
12 Europe
11 Canada
2 Australia
2 South Africa
24 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TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or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**

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, 2 Seqens, 3 DKSH, 1 Jai Radhe Sales, 4 Boai NKY Pharmaceuticals Ltd, 11 Gangwal Healthcare, 5 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

63 Fillers, Diluents & Binders, 51 Coating Systems & Additives, 36 Direct Compression, 31 Disintegrants & Superdisintegrants, 28 Controlled & Modified Release, 24 Thickeners and Stabilizers, 20 Granulation, 18 Solubilizers, 16 Co-Processed Excipients, 15 Lubricants & Glidants, 13 Topical, 12 Parenteral, 12 Film Formers & Plasticizers, 9 Chewable & Orodispersible Aids, 7 Taste Masking, 7 Emulsifying Agents, 6 API Stability Enhancers, 5 Empty Capsules, 4 Coloring Agents, 4 Rheology Modifiers, 4 Vegetarian Capsules, 3 Surfactant & Foaming Agents

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

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 18 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
18 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

12 Finished Drug Prices

12 Finished Drug Prices

MARKET PLACE

23 APIs, 11 FDF Dossiers

23 APIs
11 FDF Dossiers

REF. STANDARDS & IMPURITIES

3 EDQM, 1 USP, 2 Others

3 EDQM
1 USP
2 Others

$ API Ref.Price (USD/KG) : 187 Xls

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11 All

01 2APOTEX INC

02 1JAMP PHARMA CORPORATION

03 2LABORATOIRE RIVA INC.

04 1OMEGA LABORATORIES LIMITED

05 2PALADIN PHARMA INC.

06 1PFIZER CANADA ULC

07 1SANDOZ CANADA INCORPORATED

08 1STERIMAX INC

filter Active Ingredients Reset all filters

11 All

01 11LABETALOL HYDROCHLORIDE

filter Dosage Form Reset all filters

11 All

01 5SOLUTION

02 6TABLET

filter Brand Name Reset all filters

11 All

01 2APO-LABETALOL

02 1LABETALOL HYDROCHLORIDE INJECTION

03 4LABETALOL HYDROCHLORIDE INJECTION USP

04 2RIVA-LABETALOL

05 2TRANDATE

FDF Dossiers
FDA Orange Book
Europe
Canada
Australia
South Africa
Listed Dossiers

List of Suppliers

Product Main Page

01

APOTEX INC

Luxepack

Not Confirmed

APOTEX INC

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Digital Content

Regulatory Info : Prescription

Registration Country : Canada

LABETALOL HYDROCHLORIDE

Brand Name : APO-LABETALOL

Dosage Form : TABLET

Dosage Strength : 100MG

Packaging : 100

Approval Date :

Application Number : 2243538

Regulatory Info : Prescription

Registration Country : Canada

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

APOTEX INC

Luxepack

Not Confirmed

APOTEX INC

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Digital Content

Regulatory Info : Prescription

Registration Country : Canada

LABETALOL HYDROCHLORIDE

Brand Name : APO-LABETALOL

Dosage Form : TABLET

Dosage Strength : 200MG

Packaging : 100

Approval Date :

Application Number : 2243539

Regulatory Info : Prescription

Registration Country : Canada

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

OMEGA LABORATORIES LIMITED

Luxepack

Not Confirmed

OMEGA LABORATORIES LIMITED

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Digital Content

Regulatory Info : Prescription

Registration Country : Canada

LABETALOL HYDROCHLORIDE

Brand Name : LABETALOL HYDROCHLORIDE INJECTION

Dosage Form : SOLUTION

Dosage Strength : 5MG/ML

Packaging : 20ML/40ML

Approval Date :

Application Number : 2457040

Regulatory Info : Prescription

Registration Country : Canada

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

PFIZER CANADA ULC

Luxepack

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PFIZER CANADA ULC

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Digital Content

Regulatory Info : Prescription

Registration Country : Canada

LABETALOL HYDROCHLORIDE

Brand Name : LABETALOL HYDROCHLORIDE INJECTION USP

Dosage Form : SOLUTION

Dosage Strength : 5MG/ML

Packaging : 20ML

Approval Date :

Application Number : 2391090

Regulatory Info : Prescription

Registration Country : Canada

Portfolio PDF

Product Web Link

Digital Content

05

SANDOZ CANADA INCORPORATED

Luxepack

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SANDOZ CANADA INCORPORATED

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Digital Content

Regulatory Info : Prescription

Registration Country : Canada

LABETALOL HYDROCHLORIDE

Brand Name : LABETALOL HYDROCHLORIDE INJECTION USP

Dosage Form : SOLUTION

Dosage Strength : 5MG/ML

Packaging : 1X20ML

Approval Date :

Application Number : 2231689

Regulatory Info : Prescription

Registration Country : Canada

Product Web Link

Digital Content

06

STERIMAX INC

Luxepack

Not Confirmed

STERIMAX INC

Luxepack

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Digital Content

Regulatory Info : Prescription

Registration Country : Canada

LABETALOL HYDROCHLORIDE

Brand Name : LABETALOL HYDROCHLORIDE INJECTION USP

Dosage Form : SOLUTION

Dosage Strength : 5MG/ML

Packaging : 20ML/40ML

Approval Date :

Application Number : 2385120

Regulatory Info : Prescription

Registration Country : Canada

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

PALADIN PHARMA INC.

Country

Luxepack

Not Confirmed

PALADIN PHARMA INC.

Country

Luxepack

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Virtual Booth

Digital Content

Regulatory Info : Prescription

Registration Country : Canada

LABETALOL HYDROCHLORIDE

Brand Name : TRANDATE

Dosage Form : TABLET

Dosage Strength : 100MG

Packaging : 100

Approval Date :

Application Number : 2106272

Regulatory Info : Prescription

Registration Country : Canada

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

08

PALADIN PHARMA INC.

Country

Luxepack

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PALADIN PHARMA INC.

Country

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Regulatory Info : Prescription

Registration Country : Canada

LABETALOL HYDROCHLORIDE

Brand Name : TRANDATE

Dosage Form : TABLET

Dosage Strength : 200MG

Packaging : 100

Approval Date :

Application Number : 2106280

Regulatory Info : Prescription

Registration Country : Canada

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

09

LABORATOIRE RIVA INC.

Country

Luxepack

Not Confirmed

LABORATOIRE RIVA INC.

Country

Luxepack

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Country

Virtual Booth

Digital Content

Regulatory Info : Prescription

Registration Country : Canada

LABETALOL HYDROCHLORIDE

Brand Name : RIVA-LABETALOL

Dosage Form : TABLET

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number : 2489406

Regulatory Info : Prescription

Registration Country : Canada

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

10

LABORATOIRE RIVA INC.

Country

Luxepack

Not Confirmed

LABORATOIRE RIVA INC.

Country

Luxepack

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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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Country

Virtual Booth

Digital Content

Regulatory Info : Prescription

Registration Country : Canada

LABETALOL HYDROCHLORIDE

Brand Name : RIVA-LABETALOL

Dosage Form : TABLET

Dosage Strength : 200MG

Packaging :

Approval Date :

Application Number : 2489414

Regulatory Info : Prescription

Registration Country : Canada

Portfolio PDF

Product Web Link

Virtual Booth

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Website

Corporate PDF

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