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Regulatory Support for Long Acting Drug Delivery

VitalDose® Ethylene-vinyl acetate copolymers (EVA) have been approved for use in numerous pharmaceutical and medical device applications around the world.

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 prepared to support customers’ regulatory filings and approvals.

Celanese provides various certifications to address technical requirements and regulatory compliance, including but not limited to USP Class VI and ISO 10993 biocompatibility, European Pharmacopeia, European and FDA Food Contact, REACH, etc.

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