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Formulation-related
General Regulatory
Packaging & Storage Conditions
Quality Status
Stability or Tox Studies
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Is DMF documentation available for Roquette products?


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 the DMF status of a particular product, please contact us or your local Roquette representative.


What information is available on the effect and dosage of polyols on newborn babies during the first months?

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

Do Roquette products comply with Pharmacopeias?

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

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