DataLase and Colorcon Inc. Sign Licensing Agreement to Develop DataLase PHARMAMARK
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The DataLase PHARMAMARK additives are excipients that meet all appropriate compendial and regulatory requirements for use in these countries and they have been used in approved pharmaceuticals for many years. A U.S. Drug Master File (DMF) will be submitted which will contain all additive and laser technology details needed for review by FDA during drug registration. Additional supporting studies are currently being performed which will be included in the DMF. Colorcon and DataLase plan to coordinate a meeting with the FDA in the near future to discuss this technology and answer any questions they may have.
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- Companies:
- Colorcon Inc., No-Tox Products Div.
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