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Is DMF documentation available for Roquette products?

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Roquette has issued several DMFs for excipients or active ingredients;
Access to these DMFs can be given upon request.
Not all excipients or actives need a DMF so Roquette has developed alternative procedures that provide access to the information required by the regulatory authorities.

For more information on this issue, please contact us or your local representative.

Other questions - General regulatory

Do Roquette products comply with Pharmacopeias?

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Do Roquette’s liquid sorbitols comply with the USP/NF monograph?

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What documentation is available for the CTD (Common Technical Document)?

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