About

Chr. Olesen Synthesis - Reliable since 2011

History

Chr. Olesen Synthesis is a Danish manufacturer
of APIs and advanced intermediates.

Chr. Olesen Synthesis is focusing on controlled substances within opioid (morphine, thebaine) and amphetamine based chemistry. Our primary product group within opioids is buprenorphine (APIs and intermediates), but we also have products like eg hydromorphone hcl. Within amphetamines we are the only company to have a CEP for dexamphetamine sulphate and are also expanding into other amphetamines. In addition we can offer a selection of non contolled APIs and advanced intermediates.

The Factory

Manufacturing is taking place in a well-equipped, up-to-date and efficient production facility comprising more than 8,000 m2 and including:

• cGMP-compliant documentation and equipment with capacity to manufacture batches ranging in size from a few kilos up to 700-800 kilos
• 30,000 liters reactor capacity increasing to 35.000 liters capacity with technologies to perform a wide variety of chemical reactions and final product handling
• Lean and experienced organization of 40 FTEs

COS has a documented capability to develop, register and market a broad range of synthetic active substances and holds certificates of suitability from the European Directorate for the Quality of Medicines & HealthCare (EDQM) for several products. The facility has a history of developing more than 50 new APIs.

Today COS focuses on approximately 10 selected APIs and advanced intermediates. The main focus is on controlled substances comprising semi-synthetic opioids (morphine and thebaine based) and fully synthetic opioids (amphetamines). COS produces these substances using a variety of chemical synthetic methods in multi-step reactions and has the capability of producing batches ranging in size from a few kilos up to 700-800 kilos.

The selected product focus of COS is complementing its production setup, which is characterised by high flexibility and focus on small and medium-sized batches. In addition, COS is able to apply its in-house expertise to develop and optimise alternate synthetic routes and thereby optimising production efficiency.

We are also offering contract development and production services for new APIs and intermediates.

Historical timeline of the API manufacturing plant

Timeline

2022
2022

Expected launch of Apomorphine & Sugammadex

2021
2021

Launch of buprenorphine Base

2020
2020

Launch of buprenorphine HCl

2019
2019

Launch of dexamphetamine base

2018
2018

Launch of dexamphetamine sulphate

2017
2017

Launch of hydromorphone HCl

2014
2014

2014/15

2014 commencing regular commercial production after GMP approval of key products mid year
2012
2012

Major event

  Re-establish production in synthetic workshop. Initial production of 4 APIs & 2 intermediates.
2011
2011

Ownership change Oct 2011

Ownership change Oct 2011
The plant was acquired by Chr. Olesen Pharmaceuticals A/S, and COS was established
2011

Major event Feb 2011

PharmaZell closed the plant as a part of its global restructuring process
2007
2007

Ownership change 2007 – 2011

Ownership change 2007 – 2011
2007

Major event

ParmaZell acquired the plant with the purpose of using it as a technology base for API development
2005
2005

Major event

Novartis acquired Hexal and merged it with Sandoz to create a leading generics player
2005

Ownership change 2005 – 2007

Ownership change 2005 – 2007
1998
1998

Major event

Hexal acquired the plant from BMS to bypass certain product patents, for which only the production processes were patented in Denmark
1998

Ownership change 1998-2005

Ownership change 1998-2005
1995
1995

Major event

BMS acquire plant with focus on developing a high-quality API production facility
1995

Ownership change 1995 – 1998

Ownership change 1995 – 1998
1970
1970

1970s – 1995

GEA Farmaceutisk Fabrik A/S