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

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Prazepine
Europe

TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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Your reliable CDMO partner - agile, scalable, top-quality Small Molecule API & HPAPI solutions from concept to market

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pharmacompass-1-m-2025-11-24

AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.

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pharmacompass-2-m-2025-11-03

Prazepine

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

11 API Suppliers, 9 USDMF, 1 EU WC, 1 NDC API, 3 Listed Suppliers, $ API Reference Price

11 API Suppliers
9 USDMF
1 EU WC
1 NDC API
3 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

INTERMEDIATES

5 Intermediate Suppliers

5 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

30 FDF Dossiers, 16 FDA Orange Book, 8 Europe, 3 Australia, 2 South Africa, 1 Listed Dossiers

30 FDF Dossiers
16 FDA Orange Book
8 Europe
3 Australia
2 South Africa
1 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - EQ 125MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - EQ 150MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - EQ 75MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE;ORAL - EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE;ORAL - EQ 125MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE;ORAL - EQ 150MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE;ORAL - EQ 75MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

3 SPI Pharma, 8 DKSH, 2 Gangwal Healthcare, 4 ACG Worldwide, 1 Aeon Procare, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 5 BASF, 1 DFE Pharma, 3 Gangwal Chemicals, 3 Ingredion Pharma Solutions, 1 Keval Exports, 3 Lonza Capsugel, 5 Microlex e.U, 1 Nitika Pharmaceutical Specialities, 1 Pharmatrans-Sanaq, 3 Pluviaendo, 2 Prachin Chemical, 1 Qualicaps, 10 Roquette, 1 Seppic, 2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 3 Sigachi Industries, 2 Silverline Chemicals, 2 Vasa Pharmachem

3 SPI Pharma
8 DKSH
2 Gangwal Healthcare
4 ACG Worldwide
1 Aeon Procare
4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
5 BASF
1 DFE Pharma
3 Gangwal Chemicals
3 Ingredion Pharma Solutions
1 Keval Exports
3 Lonza Capsugel
5 Microlex e.U
1 Nitika Pharmaceutical Specialities
1 Pharmatrans-Sanaq
3 Pluviaendo
2 Prachin Chemical
1 Qualicaps
10 Roquette
1 Seppic
2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
3 Sigachi Industries
2 Silverline Chemicals
2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

21 Fillers, Diluents & Binders, 15 Lubricants & Glidants, 12 Disintegrants & Superdisintegrants, 8 Empty Capsules, 8 Coating Systems & Additives, 8 Thickeners and Stabilizers, 6 Direct Compression, 6 Taste Masking, 5 Granulation, 4 Co-Processed Excipients, 3 Chewable & Orodispersible Aids, 3 Coloring Agents, 3 Emulsifying Agents, 3 Film Formers & Plasticizers, 2 Controlled & Modified Release, 1 Surfactant & Foaming Agents, 1 API Stability Enhancers, 1 Topical

21 Fillers, Diluents & Binders
15 Lubricants & Glidants
12 Disintegrants & Superdisintegrants
8 Empty Capsules
8 Coating Systems & Additives
8 Thickeners and Stabilizers
6 Direct Compression
6 Taste Masking
5 Granulation
4 Co-Processed Excipients
3 Chewable & Orodispersible Aids
3 Coloring Agents
3 Emulsifying Agents
3 Film Formers & Plasticizers
2 Controlled & Modified Release
1 Surfactant & Foaming Agents
1 API Stability Enhancers
1 Topical

DIGITAL CONTENT

6 News #PharmaBuzz

6 News #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 2 Regulatory FDF Prices

2 US Medicaid Prescriptions
2 Regulatory FDF Prices

MARKET PLACE

2 APIs

2 APIs

REF. STANDARDS & IMPURITIES

3 Others

3 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 222 Xls

Filters

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FILTER :

filter Applicant Reset all filters

8 All

01 2AMDIPHARM LTD

02 2Crescent Pharma International Limited

03 2Novartis Sweden Ab

04 2Remedica Limited

filter Active Ingredients Reset all filters

8 All

01 2Imipramine

02 6Imipramine Hydrochloride

filter Dosage Form Reset all filters

8 All

01 5Coated Tablet

02 1Film Coated Tablet

03 1Imipramine 10Mg 60 Units Oral Use

04 1Imipramine 25Mg 50 Combined Oral Use

filter Country Reset all filters

8 All

01 2Italy

02 4Malta

03 2Sweden

filter Brand Name Reset all filters

8 All

01 4Imipramine

02 4Tofranil

List of Suppliers

Product Main Page

01

AMDIPHARM LTD

CPhI India

Not Confirmed

AMDIPHARM LTD

CPhI India

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.

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Digital Content

Regulatory Info :

Registration Country : Italy

Brand Name : Tofranil

Dosage Form : Imipramine 10Mg 60 Units Oral Use

Dosage Strength : 60 cpr riv 10 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

AMDIPHARM LTD

CPhI India

Not Confirmed

AMDIPHARM LTD

CPhI India

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.

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Digital Content

Regulatory Info :

Registration Country : Italy

Brand Name : Tofranil

Dosage Form : Imipramine 25Mg 50 Combined Oral Use

Dosage Strength : 50 cpr riv 25 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Crescent Pharma International Limited

CPhI India

Not Confirmed

Crescent Pharma International Limited

CPhI India

Not Confirmed

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Digital Content

Regulatory Info : Authorised

Registration Country : Malta

Imipramine Hydrochloride

Brand Name : Imipramine

Dosage Form : Coated Tablet

Dosage Strength : 10MG

Packaging :

Approval Date : 2020-01-10

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Crescent Pharma International Limited

CPhI India

Not Confirmed

Crescent Pharma International Limited

CPhI India

Not Confirmed

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Digital Content

Regulatory Info : Authorised

Registration Country : Malta

Imipramine Hydrochloride

Brand Name : Imipramine

Dosage Form : Coated Tablet

Dosage Strength : 25MG

Packaging :

Approval Date : 2020-01-10

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Novartis Sweden Ab

CPhI India

Not Confirmed

Novartis Sweden Ab

CPhI India

Not Confirmed

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Digital Content

Regulatory Info : Deregistered

Registration Country : Sweden

Imipramine Hydrochloride

Brand Name : Tofranil

Dosage Form : Coated Tablet

Dosage Strength : 10mg

Packaging :

Approval Date : 12/04/1962

Application Number : 19620412000030

Regulatory Info : Deregistered

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Novartis Sweden Ab

CPhI India

Not Confirmed

Novartis Sweden Ab

CPhI India

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.

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Digital Content

Regulatory Info : Deregistered

Registration Country : Sweden

Imipramine Hydrochloride

Brand Name : Tofranil

Dosage Form : Coated Tablet

Dosage Strength : 25mg

Packaging :

Approval Date : 12/04/1962

Application Number : 19620412000016

Regulatory Info : Deregistered

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Remedica Limited

Country

CPhI India

Not Confirmed

Remedica Limited

Country

CPhI India

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.

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Country

Virtual Booth

Digital Content

Regulatory Info : Withdrawn

Registration Country : Malta

Imipramine Hydrochloride

Brand Name : Imipramine

Dosage Form : Coated Tablet

Dosage Strength : 25MG

Packaging :

Approval Date : 2006-11-15

Application Number :

Regulatory Info : Withdrawn

Registration Country : Malta

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

08

Remedica Limited

Country

CPhI India

Not Confirmed

Remedica Limited

Country

CPhI India

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.

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Country

Virtual Booth

Digital Content

Regulatory Info : Authorised

Registration Country : Malta

Imipramine Hydrochloride

Brand Name : Imipramine

Dosage Form : Film Coated Tablet

Dosage Strength : 25MG

Packaging :

Approval Date : 2010-12-30

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

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