Strukmyer


Strukmyer, established in 1996 and located in Dallas, TX, is a world-class manufacturer specializing in medical devices, biologic products, pharmaceutical compounding, and more. They are FDA registered, ISO 13485:2016 certified, and offer a wide range of products including adhesives, collagen, wound care, and pharmaceutical fillings. Their mission is to help get products to market quickly through R&D, design, engineering, contract manufacturing, and regulatory compliance, with a focus on patient safety and quality.

Industries

biotechnology
manufacturing
medical-device
pharmaceutical

Nr. of Employees

medium (51-250)

Strukmyer


Products

Collagen powder dressing

Highly absorbent Type I bovine collagen powder dressing formulated to absorb ≥20x its weight and form a gel on contact with wound exudate; produced with low pH and depyrogenation controls.

Collagen pads and sheets

Physically cross-linked collagen pads and sheets manufactured from 100% Type I bovine collagen for use in wound care and surgical applications; produced without aldehydes or peroxides.

Advanced wound care dressings (foam, hydrocolloid, hydrogel, antimicrobial)

Portfolio of wound dressings including foam dressings, hydrocolloids, hydrogels and composite antimicrobial dressings combining barriers, absorbent layers and adhesive borders.

Medical-grade adhesive tapes and foam tapes

Medical-grade adhesive tapes and foam tapes formulated for skin contact, including acrylic-based, rubber-based, synthetic hot melt, removable and low surface energy options.

OTC and cosmetic liquid and powder formulations

Formulation and filling of over-the-counter liquid and powder products and cosmetic creams/gels with USP actives and controlled manufacturing processes.

Sterile water and saline products

Sterile water and sterile saline prepared and packaged for medical use (listed among cleared/marketed device products).


Services

End-to-end services from R&D and design through engineering, scale-up, sourcing, sterilization, packaging and regulatory support for medical, OTC and cosmetic products.

Sterile and non-sterile compounding services in dedicated cleanrooms for drug products registered under outsourcing facility provisions.

Custom mixing, compounding, filling and packaging of liquids and powders with options for applicators, tubes, bottles, syringes and multi-use formats.

Assembly and packaging of products requiring low-particulate environments using ISO Class 8 (and better) cleanrooms and sterile packaging workflows.

Precision converting services including rotary/flat-bed die cutting, tight-tolerance slitting and flexible material converting for medical components.

Inline and offline multi-color printing and surface treatment (corona) for labels, films and packaging substrates.

Expertise Areas

  • Contract manufacturing (CDMO) for medical devices and pharmaceuticals
  • Pharmaceutical compounding and sterile drug filling (503b)
  • Advanced wound care product development and manufacturing
  • Adhesive and foam converting for medical applications
  • Show More (4)

Key Technologies

  • ISO Class 7/8 HEPA-filtered cleanrooms
  • Lyophilization
  • USP-grade water purification (0.2 micron filtration, stainless-steel loop)
  • Physical cross-linking of collagen
  • Show More (6)

News & Updates

Posted on February 14, 2025, seeking a Master’s degree in Industrial Engineering to optimize production strategies.

Manufactures advanced wound dressings designed to promote moist wound healing.

Manufactures various pharmaceutical fillings with ISO certification.

Details about Strukmyer’s capabilities, certifications, and product portfolio.

Highlights benefits of outsourcing pharmaceutical manufacturing to Strukmyer.

Discusses the safety and efficacy of the bridge-enhanced ACL repair procedure.

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