TOLMAR Inc.

Tolmar is a pharmaceutical research, development, manufacturing and commercial operations company based in northern Colorado. Tolmar provides our customers with a competitive and sustainable combination of product development and commercial services. Tolmar develops and manufactures proprietary and generic pharmaceutical products with a specific focus on therapeutic areas of dental, dermatology and oncology.

Product Development

With a strong employee base of research scientists, chemists and engineers, Tolmar has more than 20 approved and marketed pharmaceutical products. Additionally, Tolmar currently has more than a dozen products in active clinical trials and under review at the FDA, and more products in the development stage. Capabilities of Tolmar include formulations and analytical development, primary package design and development, and IND, ANDA and NDA CMC support. Process development capabilities include commercial scale up and validation.

Commercial Product Development

With more than 20 years of formulation development experience, the expertise in the research and development department of Tolmar includes formulation development, analytical methods, process development and scale up in addition to 510(k), ANDA, IND and NDA submissions. Tolmar has a full pipeline of additional products in all stages of development.

Tolmar has a wide variety of production capabilities including creams (aluminum, plastic tubes), ointments (aluminum, plastic tubes), gels (aluminum, plastic tubes), solutions (glass, plastic bottles), liquids (glass, plastic bottles), injectables (powder, liquid fills) and powder fill (syringes, vials).

The production facilities at Tolmar include chemistry and microbiology laboratories; multi-shift production operation; cGMP and EU cGMP compliant manufacturing; liquid, semi-solid, lyophilization, and injectable filling lines; and warehouse and cold-chain distribution capabilities.  Dosage forms are primarily semisolids, liquids and injectables.

Tolmar is an EU approved facility for aseptic processing and syringe filling, and an FDA approved facility for aseptic, semi-solid and syringe filling. Tolmar has cGMP and EU cGMP compliant EU grade A, B, C and D manufacturing environments for aseptic, semisolid manufacturing and syringe filling. Tolmar is also ISO 13485 registered for medical devices.