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Article: PERSEPTIVE BIOSYSTEMS SUBMITS DRUG MASTER FILE WITH FDA COVERING POROS CHROMATOGRAPHY MEDIA
- Article from:
- PR Newswire
- Article date:
- June 25, 1992
CopyrightCOPYRIGHT 1992 PR Newswire Association LLC. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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PERSEPTIVE BIOSYSTEMS SUBMITS DRUG MASTER FILE WITH FDA
COVERING POROS CHROMATOGRAPHY MEDIA
CAMBRIDGE, Mass., June 25 /PRNewswire/ -- PerSeptive Biosystems, Inc. (NASDAQ: PBIO) announced today that it has submitted a Drug Master File with the U.S. Food & Drug Administration. The Drug Master File covers manufacturing and test protocols of the company's POROS(R) chromatographic materials for production scale biomolecule purification.
The Drug Master File submission facilitates FDA regulatory filings by PerSeptive Biosystems' customers because they can incorporate POROS manufacturing information into their New Drug Applications (NDA) and ...
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