Cephalexin | Marketing Authorisations | MA | Europe | PharmaCompass.com

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Cephalexin
Europe

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

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With Virupaksha, you get a quality product with on-time delivery.

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pharmacompass-1-m-2025-11-24

Munit offers scalable GMP micronization and particle size engineering to enhance drug solubility, bioavailability, and performance.

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ChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.

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pharmacompass-2-m-2025-11-03

Cephalexin

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

29 API Suppliers, 21 USDMF, 4 JDMF, 1 EU WC, 5 NDC API, 3 Listed Suppliers, $ API Reference Price

29 API Suppliers
21 USDMF
4 JDMF
1 EU WC
5 NDC API
3 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

16 Drugs in Development

16 Drugs in Development

INTERMEDIATES

4 Intermediate Suppliers

4 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

181 FDF Dossiers, 97 FDA Orange Book, 15 Europe, 6 Canada, 2 South Africa, 61 Listed Dossiers

181 FDF Dossiers
97 FDA Orange Book
15 Europe
6 Canada
2 South Africa
61 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - EQ 333MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE;ORAL - EQ 333MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE;ORAL - EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE;ORAL - EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

3 Rochem International Inc, 6 SPI Pharma, 14 DKSH, 1 Pharm-RX Chemical, 5 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 3 Kirsch Pharma, 4 ACG Worldwide, 6 Actylis, 1 Aeon Procare, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 9 BASF, 2 CD Formulation, 1 Clariant, 7 DFE Pharma, 2 Finar, 9 Gangwal Chemicals, 1 Ideal Cures, 4 Ingredion Pharma Solutions, 16 Kerry, 4 Keval Exports, 1 Kima Chemical, 3 Lonza Capsugel, 13 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Pharmatrans-Sanaq, 5 Pluviaendo, 4 Prachin Chemical, 1 Qualicaps, 23 Roquette, 8 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 4 Silverline Chemicals, 1 The Dow Chemical Company, 1 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

48 Fillers, Diluents & Binders, 37 Thickeners and Stabilizers, 29 Direct Compression, 26 Disintegrants & Superdisintegrants, 24 Granulation, 18 Solubilizers, 16 Coating Systems & Additives, 15 Lubricants & Glidants, 14 Taste Masking, 13 Topical, 12 Rheology Modifiers, 12 Parenteral, 11 Co-Processed Excipients, 10 Film Formers & Plasticizers, 8 Empty Capsules, 7 Emulsifying Agents, 7 Controlled & Modified Release, 7 Chewable & Orodispersible Aids, 5 Surfactant & Foaming Agents, 3 Coloring Agents, 3 API Stability Enhancers

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

DIGITAL CONTENT

112 News #PharmaBuzz

112 News #PharmaBuzz

GLOBAL SALES INFORMATION

12 US Medicaid Prescriptions, 10 Regulatory FDF Prices

12 US Medicaid Prescriptions
10 Regulatory FDF Prices

MARKET PLACE

14 APIs, 4 FDF Dossiers

14 APIs
4 FDF Dossiers

PATENTS & EXCLUSIVITIES

2 US Exclusivities

2 US Exclusivities

REF. STANDARDS & IMPURITIES

12 Others

12 Others

$ API Ref.Price (USD/KG) : 67 Xls

Filters

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15 All

01 3CRINOS SpA

02 1Central Procurement & Supplies Unit

03 1Farmarosib SRL

04 1Ldp Torlan Laboratories Sa

05 2Meda Ab

06 1Medicem Limited

07 1Medochemie Limited

08 1Mylan Ab

09 1NeoFarma Pharmaceuticals Limited

10 1P & D Pharmaceuticals Limited

11 1Phadisco Limited

12 1TEOFARMA Srl

filter Active Ingredients Reset all filters

15 All

01 5Cefalexin

02 2Cefalexin Monohydrate

03 5Cephalexin

04 3Cephalexin Monohydrate

filter Dosage Form Reset all filters

15 All

01 4Capsule

02 2Cephalexin 1.000Mg 8 Joined' Oral Use

03 1Cephalexin 5% 100Ml Oral Use

04 1Cephalexin 500Mg 8 Joined' Oral Use

05 1Film Coated Tablet

06 3Granule For Oral Suspension

07 3Tablet

filter Country Reset all filters

15 All

01 4Italy

02 7Malta

03 1Spain

04 3Sweden

filter Brand Name Reset all filters

15 All

01 1Cefalexin Mylan

02 1Cefalexin Oral

03 1Cefalexina Arena

04 1Ceporex

05 6Keflex

06 3Keforal

07 1Medolexin

08 1Torlasporin Capsules

List of Suppliers

Product Main Page

01

Medochemie Limited

CTAD25

Not Confirmed

Medochemie Limited

CTAD25

Not Confirmed

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Digital Content

Regulatory Info : Authorised

Registration Country : Malta

Brand Name : Medolexin

Dosage Form : Capsule

Dosage Strength : 250MG

Packaging :

Approval Date : 2007-10-19

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Mylan Ab

CTAD25

Not Confirmed

Mylan Ab

CTAD25

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Digital Content

Regulatory Info : Deregistered

Registration Country : Sweden

Cephalexin Monohydrate

Brand Name : Cefalexin Mylan

Dosage Form : Tablet

Dosage Strength : 500mg

Packaging :

Approval Date : 15/02/1995

Application Number : 19950215000044

Regulatory Info : Deregistered

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

CRINOS SpA

Country

CTAD25

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CRINOS SpA

Country

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Regulatory Info :

Registration Country : Italy

Brand Name : Keforal

Dosage Form : Cephalexin 5% 100Ml Oral Use

Dosage Strength : grat os suspe 100 ml 5%

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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04

CRINOS SpA

Country

CTAD25

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CRINOS SpA

Country

CTAD25

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Regulatory Info :

Registration Country : Italy

Brand Name : Keforal

Dosage Form : Cephalexin 500Mg 8 Joined' Oral Use

Dosage Strength : 8 cpr riv 500 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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05

CRINOS SpA

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CRINOS SpA

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Regulatory Info :

Registration Country : Italy

Brand Name : Keforal

Dosage Form : Cephalexin 1.000Mg 8 Joined' Oral Use

Dosage Strength : 8 cpr riv 1 g

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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06

TEOFARMA Srl

Country

CTAD25

Not Confirmed

TEOFARMA Srl

Country

CTAD25

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Regulatory Info :

Registration Country : Italy

Brand Name : Ceporex

Dosage Form : Cephalexin 1.000Mg 8 Joined' Oral Use

Dosage Strength : 8 cpr riv 1 g

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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07

Meda Ab

Country

CTAD25

Not Confirmed

Meda Ab

Country

CTAD25

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Regulatory Info : Deregistered

Registration Country : Sweden

Cephalexin Monohydrate

Brand Name : Keflex

Dosage Form : Granule For Oral Suspension

Dosage Strength : 50mg/ml

Packaging :

Approval Date : 10/03/1972

Application Number : 19720310000023

Regulatory Info : Deregistered

Registration Country : Sweden

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08

Meda Ab

Country

CTAD25

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Meda Ab

Country

CTAD25

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Regulatory Info : Deregistered

Registration Country : Sweden

Cephalexin Monohydrate

Brand Name : Keflex

Dosage Form : Tablet

Dosage Strength : 500mg

Packaging :

Approval Date : 14/04/1972

Application Number : 19720414000011

Regulatory Info : Deregistered

Registration Country : Sweden

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09

Ldp Torlan Laboratories Sa

Country

CTAD25

Not Confirmed

Ldp Torlan Laboratories Sa

Country

CTAD25

Not Confirmed

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Regulatory Info : Cancelled

Registration Country : Spain

Brand Name : Torlasporin Capsules

Dosage Form : Capsule

Dosage Strength :

Packaging :

Approval Date : 1974-07-01

Application Number : 52484

Regulatory Info : Cancelled

Registration Country : Spain

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10

Phadisco Limited

Country

CTAD25

Not Confirmed

Phadisco Limited

Country

CTAD25

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Regulatory Info : Authorised

Registration Country : Malta

Brand Name : Keflex

Dosage Form : Capsule

Dosage Strength : 500MG

Packaging :

Approval Date : 2006-05-29

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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