Services

Our Services

Impopharma offers comprehensive drug product formulation and process development, as well as wide-ranging analytical testing services to the pharmaceutical industry, specializing in nasal and pulmonary drug products.

Impopharma is well-positioned and experienced to support virtual, mid-size, and multinational companies by providing reverse engineering and novel formulation development solutions, manufacturing and packaging solutions, and associated analytical and stability support services.

Experience

Developed seven Rx FDA-approved products , including four generic CFC pMDI products for the U.S. market

Partnered with Top U.S. and Canadian pharmaceutical companies to develop nasal sprays (solutions and suspensions) for both markets

Two ANDAs pending at FDA, with additional products in development

Currently developing projects for spray, pMDI, and mist delivery types of products

Passed the in vitro bioequivalence requirements for all of the products that it has developed to date

Participated in the United Nations development program to help transfer the pMDI products from CFC propellant to HFA for the developing nations

Successfully developed generic nebule products and ophthalmic products

Services

  • Testing and Reverse Engineering of Branded Products
  • Full Formulation Development and Pilot Scale-up
  • Technology Transfer to CMO and Management of Regulatory Submission Batch Manufacturing
  • Release Testing and Stability Studies
  • Characterization and In-use Studies
  • In vitro Bioequivalence Studies
  • Regulatory Support

Products & Expertise

  • Nasal and Pulmonary Inhalation Products
  • Pressurized Metered Dose Inhalers (pMDIs)
  • Dry Powder Inhalers (DPIs)
  • Metered Nasal Sprays
  • Small Volume Nasal Sprays (e.g. single dose)

Equipment

  • HPLCs
  • GC & GC/MS
  • Aersosol Drug Spray Analyzer (Spray Pattern & Plume Geometry)
  • Droplet Size Determination by Laser Diffraction
  • Cascade Impaction
  • Stainless Steel Drug Addition (DAV) and Mixing Vessels
  • Homogenizer
  • Vacuum Crimper
  • Diaphragm Filler
  • Mini Spray Dryer