Regulatory support - SERVICES

Regulatory support - SERVICES
Product Description

VitalDose(R) 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

Celanese Services Germany GmbH

  • DE
  • 2015
    On CPHI since
  • 5000+
    Employees
Company types
Manufacturer/Innovator
Primary activities
Packaging & drug delivery
Technology

Celanese Services Germany GmbH

  • DE
  • 2015
    On CPHI since
  • 5000+
    Employees
Company types
Manufacturer/Innovator
Primary activities
Packaging & drug delivery
Technology

More Products from Celanese Services Germany GmbH (22)

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    Product Intra vaginal rings and intra uterine devices - SOLUTIONS

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  • Microneedles - SOLUTIONS

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  • NUTRINOVA® Sorbates

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  • SUNETT(R) Sweeteners

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  • Sustained Release Drug Delivery

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    The release of active ingredients from VitalDose® Ethylene-vinyl acetate copolymers (EVA) is controlled by the process of diffusion. A wide range of molecules, both large and small, are capable of diffusing through EVA and releasing over relevant timescales.

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  • Celanese Development & Feasibility Lab Services

    Product Celanese Development & Feasibility Lab Services

    When you work with Celanese you have access to the right mix of services, support, and proven materials to accelerate your drug delivery program through technical feasibility. The Celanese Development & Feasibility Lab offers formulation development, drug release testing, form factor development, mater...

Celanese Services Germany GmbH resources (16)

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