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Chemwerth, Inc. has recently filed its first Electronic eCTD DMF with the U.S. Food and Drug Administration.

Beginning in January, 2008, chemwerth, Inc. will file all of it’s Drug Master Files in Electronic (eCTD) format. This will ensure the fastest possible Drug Master File approval cycles for chemwerth supported customers.

Currently, less then 5% of all pharmaceutical companies are filing Electronic eCTD ANDAs and DMFs with FDA. We were one of the first companies to file paper CTD formatted Drug Master Files and we are now one of the first companies to file Electronic eCTD Drug Master Files with FDA. This milestone proves once again that chemwerth continues to be at the cutting edge of Regulatory work worldwide.

 

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