| 2003D-0571 - Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances|
|FDA Comment Number :||EC6|
|Submitter :||Dr. Lutz Buettgenbach||Date & Time:||07/06/2004 02:07:00|
|Organization :||Merck KGaA, Germany|
| Dear Sir/Madam
Merck KGaA, Germany is a manufacturer of active ingredients for drug products since 1827. Today Merck is operating in the business sectors Pharmaceuticals, Chemicals and Laboratory Distribution organized in different divisions. As a pharmaceutical company, Merck KGaA develops and markets prescription drugs to satisfy unmet medical needs in large patient populations. We supply customers throughout the world including the USA.
Therefore we are affected by the 'Draft Guidance for Industry:
Drug Substance - Chemistry, Manufacturing, and Controls Information'.
We appreciate very much the opportunity to provide comments on this draft guidance for industry. Please find the comment attached.