Quality

Global regulatory compliance

Our pharmaceutical Quats are manufactured in accordance with cGMP Guide ICH Q7 for Active Pharmaceutical Ingredients, the highest available standard. We analyse according to relevant multicompendial pharmacopoeias (eg. Ph.Eur., USP/NF, JP and BP). Our pharmaceutical Quats are used in many different products such as ophthalmic, nasal sprays, topical products, oral/dental products and medical devices.

Our recombinant Insulin Human AF is a key component in serum-free growth media for mammalian cells, used for the manufacturing of monoclonal antibodies, virus vaccines, gene therapy products and other biological drugs approved by regulatory bodies worldwide.

Both Novo Nordisk and Novo Nordisk Pharmatech are regularly audited by major and minor pharmaceutical companies and inspected by the Danish Medicine Agency.
Our comprehensive documentation and services include:

  • ISO 9001 Certificate
  • GMP Certificate from the Danish Medicine Agency
  • Certificate of Analysis (current version of pharmacopoeias)
  • Customer audits
  • Declarations, statements (stability, residual solvents, TSE/BSE, GMO, allergens, elemental impurities, etc.)
  • Change Notification
  • Answering of questionnaires
  • Process flowchart
  • Packaging details
  • Enter quality assurance agreements on Novo Nordisk Pharmatech template

Quality management system

Novo Nordisk Pharmatech’s quality management system is in compliance with DS/EN ISO 9001 in all of our activities and includes production, QA/QC, sales and marketing, R&D, shipping information and customer services. The high quality of our products is ensured by our efficient quality assurance systems and quality control carried out by highly experienced professionals.

Environment and safety

Environmental considerations are an integral part of our everyday work. Our main concerns include reducing atmospheric emissions of organic solvents from the production process, and carbon dioxide and nitrogen oxide from the production of energy. We have implemented an Environmental Policy and are DS/EN ISO 14001 as well as OHSAS 18001 certified.

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REACH at Novo Nordisk Pharmatech

All relevant products manufactured at Novo Nordisk Pharmatech are registered with ECHA in 2008. Insulin Human products  are registered by Novo Nordisk. Our FeF® Cetrimide and FeF® CTAB products were registered in 2013. See our registration numbers and registration dates here

We are involved in the relevant SIEF groups, either as a Lead Registrant or as an active participant. Both our internal specialists as well as external consultants will insure that our products are registered in due time. A continuous dialogue with our suppliers and customers will help guarantee a smooth progression of the registration process.

 

 

Customer service

Contact
Katja von Magius Biel
Customer Service Assistant
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Mette Borgaard
Customer Service Assistant
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Susanne Holmqvist-Larsen
Customer Service Assistant
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Tina Rydahl Pedersen
Customer Service Assistant

Insulin sales

Contact
Timur Özbay
International Sales Manager for US and Europe
Contact
Matthias Brand
International Sales Manager for Asia

Quats sales

Contact
Phil Stafford
International Sales Manager for US and Europe
Contact
Kerina Sze Imm Soh
International Sales Manager for Asia

Distributors

Asia Pacific

DKSH Holding Ltg.
Wiesenstrasse 8,
P.O. Box. 888
8034 Zürich
Switzerland
Phone: +41 44 386 7272
Fax: +41 44 386 7282

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Austria

Selectchemie AG Schweiz
Etzelstrasse 42
P.O. Box 772
CH-8038 Zürich
Tel. +41 44 487 96 11
Fax. +41 44 487 96 90

Email

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Bangladesh

Signet
A-801, Crescenzo
C/38-39, G-Block
Bandra Kurla Complex
Mumbai - 400 051
India
Tel: +91 22 61462725
Fax: +91 22 61462726

Email

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Brazil

Eskisa S.A
Rua Guilherme Barbosa de Melo, 83 / 87
Brooklin Novo
CEP 04571-160 - São Paulo – SP
Brazil
Tel.: (11) 5536-0533 / 2385-0500
Fax.: (11) 5536-4152

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Canada

A&C
3010 de Baene
Saint-Laurent, Quebec
H4S 1L2
Canada
Tel: +1 514 336 1493
Toll Free: +1 800 361 9234
Fax: +1 514 336 1768

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Eastern Europe

Selectchemie AG Schweiz
Etzelstrasse 42
P.O. Box 772
CH-8038 Zürich
Tel. +41 44 487 96 11
Fax. +41 44 487 96 90

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France

Quimdis
71 RUE ANATOLE FRANCE
92300 LEVALLOIS PERRET
FRANCE
Tel + 33 (0) 1 55 46 50 00
Fax + 33 (0) 1 47 39 91 90

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Germany

Azelis Germany
Weeserweg 23
47804 Krefeld
Tel: +49 (0) 2151 7286 90
Fax. +49 (0) 2151 7286 99

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India

Signet
A-801, Crescenzo
C/38-39, G-Block
Bandra Kurla Complex
Mumbai - 400 051
India
Tel: +91 22 61462725
Fax: +91 22 61462726

Email

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Italy

IMCD Italia SpA.
Via XXV Aprile, 4
San Donato, MI 20097
Phone : +39 02 557 091
Fax : +39 02 557 09 210

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Portugal

Azelis Portugal
World Trade Center Almeda Park
Plaça de la Pau, s/n. Edificio 8, 1ª planta
Cornellà de Llobregat (Barcelona)
Spain - 8940

+34 93 409 90 70
+34 93 339 21 62

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South Africa

Warren Chem Ltd.
11 Mansell Road Killarney Gardens Cape Town,
Western Cape 7441
Tel: +27 21 556 1920
Fax: +27 21 556 1905

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Spain

Azelis Spain
World Trade Center Almeda Park
Plaça de la Pau, s/n. Edificio 8, 1ª planta
8940 Cornellà de Llobregat (Barcelona)
Tel: +34 93 409 90 70
Fax +34 93 339 21 62

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Switzerland

Selectchemie AG Schweiz
Etzelstrasse 42
P.O. Box 772
CH-8038 Zürich
Tel. +41 44 487 96 11
Fax. +41 44 487 96 90

Email

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Turkey

Kura Ltd.
Kore Sehitleri Cad.Yzb.Kaya Aldogan Sk. Nr:12/3
34394 Zincirlikuyu - Istanbul
Phone: +90 212 347 25 30
Fax: +90 212 347 35 30

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UK & Ireland

Azelis UK & Ireland
Foxholes Business Park
John Tate Road
Hertford
Herts
SG13 7YH
United Kingdom
Tel:+44 (0) 1992 825555
Fax +44 (0) 1992 825566

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USA

Brenntag Specialties
100 Coolidge Street
South Plainfield, NJ 07080

Domestic
Phone: (800) 732-0562
Fax: (800) 543-1484
International
Phone: (908) 561-6100
Fax: (908) 757-3488

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Marketing and product management

Contact
Chantale Julien
Product Manager
Contact
Marie-Louise Lyster Andersen
Global Marketing Manager
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Lene Hoffmeyer Nielsen
Junior Product Manager
Contact
Sara Gualdoni
Product Manager

Contact

Katja von Magius Biel

Customer Service Assistant

Email

Direct phone: +45 2429 4164