VitalDose® EVA has been approved for use in numerous pharmaceutical and medical device applications. Vitaldose® EVA excipients are manufactured according to agreed manufacturing practices that align with NSF/ANSI/IPEC 363 Excipient GMP requirements.
Drug Master Files and technical dossiers are provided to support customers’ regulatory approval process. Celanese provides certifications to address technical requirements and regulatory compliance including but not limited to USP Class VI and ISO10993 biocompatibility, European Pharmacopeia, European and FDA Food Contact, REACH.
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