de - Beste verfügbare Techniken (BVT) - Umweltbundesamt

Chapter 1
Country Current Company Original companies
Germany Dystar Bayer, Hoechst, BASF, textile dyes from Zeneca
Switzerland Clariant Sandoz, Hoechst Speciality Chemicals
Ciba Speciality Chemicals Ciba-Geigy
UK Avecia ICI
Yorkshire Crompton and Knowles (US)
Table 1.2: Restructuring of the major Western European dye manufacturers
[20, Bamfield, 2001]
1.3.2 Active pharmaceutical ingredients (APIs)
[2, Onken, 1996, 6, Ullmann, 2001, 21, EFPIA, 2003, 35, CEFIC, 2003]
1.3.2.1 Overview
Active Pharmaceutical Ingredients (APIs) are based on organic molecules which have been
synthesised and modified to provide medicinal products and comprise the largest segment of
available drugs. Biotechnology is part of the pharmaceutical industry today, but drugs based on
organic chemistry remain the largest part of R&D and comprise the largest percentage of new
drugs launched yearly. Figure 1.8 gives some examples, but in reality the variety in the world is
enormous.
(a) (b) (c)
Cl
NH
(d)
CH 3
N
N
O
OCH 3
Figure 1.8: Examples of APIs
O
OCH 3
R
R 1
O
NH
O
N
O
N
NH
(e)
S
COOH
R 2
O
8 Dezember 2005 OFC_BREF
R 3
CH 3
CH 3
O
O
O
NH 2 S NH
(a) Benzodiazepams (b) Penicillins
(c) Steroids (d) Indole alkaloids
(e) Barbiturates (f) Sulphonamides
(g) Pyrazolones
1.3.2.2 Legal requirements and process modifications
(f)
O
CH 2OH
CO
OH
CH 3
N
O R
N
Where API manufacture on a site requires the observance of the rules of current Good
Manufacturing Practice (cGMP) or approval by the European Medicine Evaluation Agency
(EMEA), the United States Food and Drug Administration (FDA) or other applicable medicine
approval authorities, process modifications can be only carried out fulfilling the required
variation procedure. This represents a serious obstacle for the redesign of existing processes.
This is even more the case if the API is supplied to a number of different marketing application
holders (which is the case for about 75 % of the total volume of API production).
R
(g)