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        Crescent Chemical Company

        Drug Master File

        for Collagenase NB 6 GMP Grade


        Collagenase NB 6 GMP Grade is optimized for isolation of cells designated for transplantation into humans


        NEED FDA APPROVAL DRUG MASTER FILE

        Registering a New Drug Application? Applying for Export?

        Drug Master File for Collagenase NB 6 GMP Grade


        • Allows for a smoother and hassle-free registration process with the FDA
        • Faster registration
        • Less paperwork for applicants

        According to the guidelines provided by the FDA, the Drug Master File (DMF)
        allows authorities to obtain necessary information to support

        • Investigational New Drug Application (IND)
        • New Drug Application (NDA)
        • Abbreviated New Drug Application (ANDA)
        • Another DMF
        • Export Application
        • Amendments/Supplements to any of these applications

        GMP Collagenase with DMFs

        • Enzymes currently available with DMF submission
          17458.03 Collagenase NB 6 GMP Grade
          17452.01 Collagenase NB 1 GMP Grade
          30303.01 Collagenase Neutral Protease GMP
        • Collagenases* are available in the United States through Crescent Chemical Company.
        • Collagenase NB 6 GMP is produced by Nordmark, the world’s largest and leading manufacturer of Collagenase.

        • Crescent Chemical Co., Inc. is a WBENC certified small, woman-owned business.
        • We can help satisfy your supplier diversity requirements.
        • We have been serving the scientific community for over 70 years and pride ourselves on personal attention, technical support, prompt shipping and highly competitive pricing.
        • We are the US Distributor for Nordmark Biochemical.

        Nordmark is a certified ISO 9001 supplier of biochemicals. All Nordmark biochemical products are subject to stringent quality control to meet the specifications stated in the Certificate of Analysis provided with each product.

        ? For cell isolation only. Not intended for topical applications.

        Crescent Chemical Company, Inc. | 631-348-0333 | www.crescentchemical.com

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