R&D Centerr&d manufacturing sites

Drug Product


Pharmaceutical drug development : Experience and Capabilities

With over 25 years of experience in pharmaceutical drug development, our Formulation Development Department can develop virtually any compound, and has created over 100 products currently on the market. Our

Unither’s multidisciplinary teams of fully qualified (Phar.D., MSc) experts and scientific technicians can solve any pharmaceutical drug development problem, from simple to complex.  Our wide range of services and technologies enables us to develop various dosage forms that can later be manufactured in cGMP clinical batches.

Dry Formulations

Batch Sizes Of 0.5 Kg To 50 Kg
  • Tablets, coated or uncoated, dispersible, and orodispersible
  • Hard capsules, semi-manual fill or automatic fill with pre-compression
  • Powder sachets
  • Powder stick packs
  • Blending, wet and dry granulation

Liquid Formulations

From 0.1 L To 50 L
  • Oral liquid formulations, solutions or suspensions
  • Liquid stick-packs 
  • Creams, gels, and ointments

Pharmaceutical drug development for clinical Trials

In clinical trials, the experimental drug is often compared with a placebo. Unither develops and manufactures all types of placebos in solid, semi-solid and liquid forms.

For double-blind trials, we fill tablets or hard capsules, develop the comparative dissolution method and provide ICH stability studies.

Primary Packaging

  • Blister packs (PVC/ALU, PVC-PVDC/ALU, ALU/ALU, Aclar, Triplex)
  • Stick packs and sachets filled with liquid or powder
  • Rigid tubes for tablets, flexible HDPE tubes, aluminum tubes for topicals
  • Pillboxes
  • Vials and bottles

Qualified Equipment

  • Blenders, mixer/granulators, ovens, fluidized bed dryer, roller compactor, grinder, calibration sieves
  • Tablet compression on alternating or rotary presses (single or multi punches, mono or bi-layer tablet press)
  • Tablet coating by conventional or perforated coating pan
  • Capsule filling by manual, semi-automatic or automatic filling equipment with pre-compression
  • Mixing tanks for liquids and pastes, vacuum-jacketed tank
  • Packaging in blisters and sachets, tube-filling

Facilities

  • GMP (Good Manufacturing Practices) premises, ANSM and ANSES (French agencies for human and animal health product safety) accredited pharmaceutical establishment
  • Four GMP manufacturing suites and one development platform
  • Air conditioning system, HVAC
  • Cross-contamination risk managed by independent fresh air supplies and separation of each suite from the corridor by an airlock under positive pressure
  • The premises are certified for GMP manufacturing and primary packaging

Pharmaceutical drug development by Unither