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List of Drug Master Files (JDMF) of Active Pharmaceutical Ingredients (APIs) submitted by Fermion Oy to the Review Authority in Japan (PMDA). Original Data : PMDA

Fermion Oy

About, Contact Details

EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

PRESENTATION(s)

Product List 2022, Corporate Presentation, Japan Accreditation Certificate for Oulu Plant, Japan Accreditation Certificate for Hanko Plant, List of Inspections, GMP Certificate 2021, API Product List 2022, Intermediates Product List 2022

VIDEO(s)

Company Introduction, Oulu Unit, Quality & On-Time Delivery, Turku Unit, Hanko Unit 4 Virtual Tour, Delivering Consistent API Quality, Fermion R&D, Hanko Unit 4, HPAPI Solutions

DIGITAL CONTENT

23 News

23 News

APIs // Active Pharmaceutical Ingredients

80 APIs, 71 USDMF, 20 CEP/COS, 11 JDMF, 3 KDMF, 20 NDC API, 34 Listed APIs

DEVELOPMENTS

18 Drug(s) in Development

18 Drug(s) in Development

DOSSIERs // Finished Dosage Forms

516 Dossiers, 7 FDA Orange Book, 463 Europe, 46 Canada

KEY PRODUCTS

Entacapone, Methotrexate, Nintedanib Esylate, Nitrofurantoin

INTERMEDIATES

7 Listed Products

7 Listed Products

SERVICES

All Services, Analytical, API Manufacturing, Drug Product Manufacturing, API & Drug Product Development, Packaging

All Services
Analytical
- 1 Analytical Method Development
API Manufacturing
Drug Product Manufacturing
API & Drug Product Development
- 3 API Development
Packaging
- 9 Contract Services

KEY SERVICES

Liquid Drug Product Manufacturing, Controlled Substance Manufacturing, Hormonal & Non-Hormonal Creams & Ointments, Contract Manufacturing for Cytotoxic APIs, CMO for Hormonal Gels & Solutions

EXCIPIENTS

1 Regulatory Filings, 1 USDMF

INSPECTIONS & REGISTRATIONS

13 FDA, 4 EDQM, 4 GDUFA