Quality is something that we strive for every
day. It is a process of continuous improvement and you can always
become better. Only what is best for the products is best for
our customers.
When it comes to quality we always aim to exceed expectations.
Our quality has been certified by customers and authorities
throughout the world many times. We offer our partners the monitoring
and updating of their products in all aspects of pharmaceutical
quality – from starting materials to manufacture, logistics
to final transfer to the market. Maximum safety without  compromise.
Our standards are in line with the requirements set by cGMP
guidelines and are regularly audited by foreign regulatory bodies
such as US-FDA, Brasilian ANVISA and MoH of the Kingdom of Saudi
Arabia (Ministry of Health). All our processes are explicitly
documented in the standard operation procedures (SOPs) of our
GMP manual. Nothing is left to chance here.
FDA and ANVISA Inspections
FDA Inspections
2004, 18 - 24 June
Inspectors: Ray Oji und Charles Ahn
2002, 15 – 18 April
Inspector: P. Gambrell
2000, 11 – 15 September
Inspectors: B.M. Frazier & P.F. Istafanos
1999, 10 – 12 May
Inspector: G.E. McNally
1997, 10 - 14 November
Inspector: G.J. Flynn
1997, 24 - 27 October
Inspector: D.J. Bergeson
1996, 15 - 19 January
Inspectors: D.M. Beltran & T.J. Arista
1992, 11 - 14 May
Inspector: J.D. Arnold
1982, 28 - 29 October
Inspector: P.D. Smith
ANVISA Inspections
2003, 24 - 28 May
Inspectors: M.G. Silveira & E. Fukuda
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