SERVICES - Regulatory support

Product description

VitalDose® Ethylene-vinyl acetate copolymers (EVA) have been approved for use in numerous pharmaceutical and medical device applications around the world. GMP Manufacturing is performed in accordance to IPEC guidelines for Pharmaceutical Excipients*. 

Drug Master Files and technical dossiers are provided to support are available for customers' regulatory approval. Celanese provides various 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, etc.

 * NSF/IPEC/ANSI 363 - 2014 Good Manufacturing Practices (GMP) for Pharmaceutical Excipients

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