https://www.avient.com/company/sustainability/planet/environmental-stewardship/agency-support
Food, Drug, Medical
Drug Master Files
FDA Drug Master Files and Medical Application Files.
https://www.avient.com/sites/default/files/2023-01/Mevopur Colorants _ Additives Brochure.pdf
COMPREHENSIVE REGULATORY TESTING
AND DOCUMENTATION
Raw materials tested to:
• ISO 10993-1 and USP , (biological
evaluation)
• European Pharmacopeia 3.1.3/3.1.5 (polyolefin
—materials used for the manufacture of
containers)
• USP (polyethylene—plastic materials of
construction)
• ICH Q3D (elemental impurities)
We provide Drug Master File (Type III) documentation
and other supporting regulatory declarations that
are relevant for the application.
Mevopur color and performance concentrates as
well as ready-to-use formulations add value to a
wide range of applications:
MEDICAL DEVICES
• Drug delivery
• Catheters
• Renal care/dialysis
• Surgical instruments
• Dental instruments
• Medical device packaging
• Electronic instruments and accessories
for monitoring
PHARMACEUTICAL PACKAGING
• Vials, ampoules
• Bottles for pills, liquid medicines
• Blister packaging
IN VITRO DIAGNOSTICS (IVD)
• Blood analysis
• IVD devices
• IVD disposables (e.g., pipette tips)
• Point-of-Care
To meet various manufacturing processes,
colorants and functional additives are provided
as concentrates for dilution into the polymer or
as ready-to-use formulations.
https://www.avient.com/sites/default/files/2020-10/auto-injector-application-study.pdf
All auto-injector designs and renderings in this
presentation were produced by Avient Design for
conceptual purposes
Avient Corporation 3
Focus on Patient Journey Self Management & Self
Administration
Technology Driven
Monitoring & Diagnostics
Increased Drug Volumes Large Molecule Biologics Faster Injections
Trends
Patient and drug development
needs are evolving at a rapid
pace.
Requirements:
Sealing the syringe and
displacing the medicant
Temperature Control
The expansion of new drugs for
different disease states allows more
patients to experience the
convenience of auto-injectors.
Thermal conductivity in a heat
exchanger body help to warm and
reduce the drug viscosity of
biologics
https://www.avient.com/sites/default/files/2024-11/Dispersions Healthcare Industry Bulletin.pdf
INDUSTRY BULLETIN
DISPERSIONS IN
HEALTHCARE
TECHNOLOGY DESCRIPTION TYPICAL APPLICATIONS
Silicone Colorant Dispersions Biocompatible, conformable silicone rubber colorants
that deliver lightfastness and aesthetic appeal
• 3D medical silicone printing
• Anatomical models and surgical guides
• External prosthetics and orthotics
• Medical ventilation/respiratory masks
• Dental and medical tools and equipment
Silicone Additive Dispersions Silicone additive solutions formulated to provide chemical
resistance, durability, and enhanced physical properties
Rubber Colorant Dispersions
Durable rubber colorants formulated for optimal
dispersion and lot-to-lot consistency to promote
ease of handling
• Medical devices and tools
• Vibration and shock control for medical
equipment
• Drug delivery devices
Urethane Colorant Dispersions Versatile urethane colorants that streamline production
and enhance quality
• Foam enclosures/support for medical tools
and equipment
• Medical and surgical devices
• Physical therapy tools
Epoxy Colorant Dispersions
Long-lasting, hygienic epoxy colorants that provide
high-cost efficiency, stability, and customization
opportunities
• Healthcare facility floor coatings
Vinyl Colorant Dispersions
Vinyl colorants developed for applications where
dispersion, uniformity, compatibility, and cleanliness
are essential
• Medical equipment
Aqueous Additive Formulations
Functional additives stabilized, suspended, and dispersed
in water that shorten development cycles, streamline
operations, and can be customized to meet specific
requirements
• Medical gloves
• Wound care
Electrically Conductive
Additives for Silicone
Innovative silicone additives to provide high conductivity
and lower filler loadings
• Neurostimulation electrode pads
• Medical tools and equipment
Laser Marking Additives for
Silicone
Dispersions containing laser absorbers and color formers
that eliminate the need for secondary etching while
promoting chemical resistance, mechanical property
retention, and production efficiency
• 3D medical silicone printing
• Anatomical models and surgical guides
• External prosthetics and orthotics
• Medical ventilation/respiratory masks
• Medical devices
Surface Modification Additives
for Silicone
Non-oil based silicone additives that reduce tackiness
and enhance smoothness of the cured compound
• Dental tools and equipment
• Medical devices, tools, and equipment
Self-Bonding Silicone Silicone compounds able to bond to various substrates
without prime coating
• Medical tools and equipment
This listing represents standard Avient dispersion technologies and addresses common healthcare applications,
but we can work with you to explore additional options.
https://www.avient.com/sites/default/files/2025-03/Q4 2024 Avient Webcast Slides w Non-GAAP.pdf
FX
• Driven by strong drug delivery
sales, new business wins in
building & construction and
consumer
• Higher sales and favorable mix
more than offset by variable
compensation reset resulting in
lower adjusted EBITDA
Copyright © .
2025 11
Specialty Engineered Materials - Q4 2024 performance
260
280
49
56
• Growth headlined by healthcare,
including engineered materials in
remote monitoring devices, as
well as composites for building &
construction, wind energy, and
defense applications
• Higher sales and favorable mix
contributed to adjusted EBITDA
growth which more than offset
unfavorable impact of variable
compensation
FY 2024
Copyright © .
2025 13
Color, Additives & Inks – full year 2024 performance
2,007
2,047
358
384
• Driven by new applications for
drug delivery and building &
construction as well as demand
recovery in packaging and
consumer
• Adjusted EBITDA margin
expansion driven by higher sales
and net price benefit
Adj.
17.8%
Adj.
18.7%
Copyright © .
2025 14
Specialty Engineered Materials – full year 2024 performance
1,138
1,197
224
249
• Growth headlined by strong
demand for applications in
defense end market and
composites used in building &
construction and engineered
materials used in healthcare
• Adjusted EBITDA margin
expansion driven by higher sales
and favorable mix
Adj.
19.7%
Adj.
20.8%
Copyright © .
2025 15
Avient full year 2024 performance vs. full year 2023
3,143
3,240
502
526
Adj.
https://www.avient.com/knowledge-base/article/regulatory-issues?ind[]=6598
Our internal Good Manufacturing Practices (GMP) guidelines govern the manufacture of intermediate products for our customer’s use in making food, drug and medical (FDM) final product applications.
FDA Drug Master Files and Medical Application Files.
https://www.avient.com/knowledge-base/article/regulatory-issues?ind[]=21508
Our internal Good Manufacturing Practices (GMP) guidelines govern the manufacture of intermediate products for our customer’s use in making food, drug and medical (FDM) final product applications.
FDA Drug Master Files and Medical Application Files.
https://www.avient.com/knowledge-base/article/regulatory-issues?rtype[]=1164
Our internal Good Manufacturing Practices (GMP) guidelines govern the manufacture of intermediate products for our customer’s use in making food, drug and medical (FDM) final product applications.
FDA Drug Master Files and Medical Application Files.
https://www.avient.com/knowledge-base/article/regulatory-issues?ind[]=6595
Our internal Good Manufacturing Practices (GMP) guidelines govern the manufacture of intermediate products for our customer’s use in making food, drug and medical (FDM) final product applications.
FDA Drug Master Files and Medical Application Files.
https://www.avient.com/products/polymer-colorants/solid-color-masterbatches/remafin-ep-white-colorants
The range is targeted for use in the production of pharma containers for parenteral, ocular, and nasal drugs.
The colorant solutions are available in PP and PE (HDPE and LDPE) and produced with ingredients tested to European Pharmacopeia 3.1.3 and 3.1.5 as well as to USP chapters , including class VI (a requirement for ophthalmic and nasal drugs) and USP and (light transmission).
Registered Drug Master File (DMF)