|
| |
CUSTOM DEVELOPMENT/PRODUCTION
OF API
Apart from
sourcing from existing producers, one of our core expertise lies in our ability
to manage from development to commercial release stage the custom or toll
production of most types of APIs.
We have all
experienced at one point the need to evaluate our current API source(s) and
consider the custom or toll approach. This may become viable when:
-
API is
no longer available from a GMP facility or is no longer supported by
regulatory (USDMF, CEP, EDMF etc)
-
Current or
market pricing has become unworkable from existing sources
-
Quality
issues exist with current suppliers
-
Strategic
intents or relationship issues drives decision to change
-
The need to
set up a secondary/fallback source
-
Purchase
volumes have fallen below certain minimum order thresholds or vaible price
breaks or bundling with other users is no longer possible
-
Geographic
rationale for source change (product stability during transport, political
instability, export/import restrictions or controls, currency exchange
volatility)
-
If the
business warrants or justifies the approach, we will identify and
qualify viable custom production options and put forward a detailed
project management timeline adapted to match your needs. We will manage this
timeline and deliverables to your satisfaction. Through our network of GMP
and cGMP facilities big and small, we have been able to set up the
production of several APIs over the years. Just this last year (2008), we
have successfully re-established the fast track development and commercial
production of three APIs for our clients. If you would like to discuss this
further with us, please do not hesitate to
communicate with us.
|
