INJECTABLE DRUG DELIVERY SOLUTIONS

• Combination Products

  Kymanox provides turnkey services to bring your product from concept to commercialization — and helps keep your product on the market. Kymanox has expertise in injectables (e.g., syringes, mechanical and electromechanical autoinjectors, wearable injectors, dual chamber systems, reconstitution systems), respiratory combination products (e.g., metered dose inhalers, dry powder inhalers, nasal sprays), and in ocular products (e.g., multi-dose containers, single-use injectables).

• Sterile Fill-Finish Facility: Your Integrated Partner For Customized Clinical Supplies

  Syngene's Sterile Fill-Finish facility is custom-built to meet market demand for clinical supplies, sterile drug products having short development timelines,

• Enabling The Delivery Of Complex Biologics With Ergonomic Solutions

  The BD UltraSafe Plus™ passive needle guard for pre-filled ISO standard glass syringes is designed to support viscous drug delivery with ergonomics and drug visibility.

• Aseptic Filling System For Pharmaceuticals: BI-MI

  Rotary filling, stoppering/tip placement/pump inserting and crimping or closing machine for bottles and vials up to 6000 u/h. The system is compatible with RABs or isolator enclosures. The system is able to work with stainless steel or ceramic rotary piston pumps or peristaltic pumps. Systems are available for manual or semi-automatic debagging, manual, semi-automatic or automatic delidding for pre-sterilized glass as well as cleanroom unscrambler’s for ophthalmic containers. Systems are 21 CFR Part 11 and audit trail compatible.

• Analytical And Testing Services

  As part of Stevanato Group’s commitment to R&D, our analytical testing facilities focus on investigating physico-chemical properties of primary packaging materials and components and studying the interactions between container closure system and drugs. Stevanato Group relies on a multi-disciplinary team of highly skilled professionals, including, scientists, engineers, pharmaceutical chemists and biotechnologists. Their knowledge and experience covers a range of specialized areas including container closure systems and drug-delivery devices.

• Daikyo Crystal Zenith® Ready-To-Use Nested Vials

  West presents Crystal Zenith vials in a nested packaging configuration, designed to meet the exterior dimensions of glass standard ISO 8362-1.

• Streamlining The Generic Combination Device Design Assessment Process

  A new six-phase assessment process simplifies regulatory approval for generic drug-device combination products, reducing costs and timelines while maintaining safety, effectiveness, and substitutability with reference-listed drugs.

• Passive Needle Guard For Pre-Filled ISO Standard Glass Syringes

  The BD UltraSafe Plus 2.25 mL Passive Needle Guard features an ergonomic design to help support injection comfort and ease of use.

• Available Fill/Finish Capacity With Exceptional Manufacturing Flexibility

  We can fill a wide range of container sizes and volumes in the clinical and commercial manufacturing of sterile injectables. Explore our capabilities in formulation and scale up, manufacturing, lyophilization, and extractables and leachables.

• Small, Simple-To-Use Package For Delivering High-Viscosity Formulations

  Subcutaneous

  Low - Medium Viscosities
  < 100 cP
  1 - 10 ml

  High - Ultra-High Viscosities
  >100 - 10,000 cP
  0.5 - 3 ml

  ArQ^® - Bios offers a small, simple to use package to deliver high viscosity formulations. Oval’s proprietary COC PDC technology allows us to build the device around a stronger drug container that can deliver 1ml of formulations up to 1000cP through a 25G needle in  less than 5 seconds. The ArQ-Bios  platform  also can deliver  greater volumes than 1 ml subject to matching  the formulation characteristics with acceptable patient tolerability.