Pharmaceutical development

Pharmaceutical development at Alphamed Formulations Private Limited (Alphamed)

Alphamed is a wholly owned subsidiary of Aspen Pharmacare Holdings Limited, South Africa.

Established in 2006 and now with a staff of 400, Alphamed, located in Hyderabad, India, has been developing a large number of drug products for various customers, and which are currently marketed across six continents.

Alphamed provides expertise in three main areas


  • Formulation & Process development for all types of solid Orals, Liquids, Semi-solids, Eye preparations and Injectables
  • New Fixed-dose Combination (FDC) formulations development
  • Patent review and non-infringing formulation / process development
  • QbD/ DoE based drug product development
  • Pre-formulation studies
  • Proto-type development, formula & process optimisation
  • Lab Screening stability studies
  • Scale-up and Technology Transfer
  • Reformulation and Life cycle management
  • Quality improvement, Process simplification, Cost reduction projects
  • New Packing / alternative packing development
  • Dedicated and separate labs for handling High-Potency molecules cytotoxic, Steroids, hormones & peptides)

Countries where the products are marketed

  • USA
  • Europe
  • Russia & CIS
  • Australia
  • Canada
  • Brazil
  • Spanish Latin America
  • South Africa
  • Sub-Saharan Africa
  • Asia


  • Analytical Methods Development, Validation and Transfer
  • Trouble shooting, Upgradation for regulatory compliance
  • Drug Substance & Drug Product – Comparative evaluation, Nitrosamines
  • ICH Q3D Elemental Impurities
  • Extractable and Leachables
  • Forced Degradation studies, Impurities isolation and characterization
  • Cleaning analytical methods development, Validation and Transfer
  • Photo-stability studies
  • ICH Stability studies
Testing release and stability

Dosage forms developed and manufactured

Solids Orals (IR/ SR/ DR):

  • Tablets (un-coated, film/sugar-coated)
  • Capsules
  • Delayed or Sustained-Release Pellets
  • Granule and Powders
  • Effervescent Tablets, Granule

 Liquid Orals:

  • Oral solutions
  • Syrups
  • Suspensions


  • Creams
  • Ointments
  • Gels


  • Aqueous Injectables
  • Oily Injectables
  • Suspension Injectables
  • Lyophilized Powders
  • Pre-filled syringes
  • Eye Preparations


  • Regulatory Intelligence service – Guideline, regulatory, pharmacopoeial updates, impact assessment
  • DMFs review, comparison, equivalency reports, DMFs compilation

Specific analytical equipment

  • Liquid Chromatography-Mass Spectrometry – Orbitrap Q-Exactive Plus (LC-MS/MS)
  • Inductively Coupled Plasma-Mass Spectroscopy (ICP-MS)
  • Inductively Coupled Plasma-Optical Emission Spectroscopy (ICP-OES)
  • X-Ray Diffraction (XRD)
  • Acquity UPLC – I Class system
  • HPLC with CAD (Charged Aerosol Detector)
  • Ion Exchange Chromatography (IC)
  • Amino acid Analyzer
  • Malvern Mastersizer 3000 & Zeta sizer
  • Microscope with photograph attachment & Software
  • Differential Scanning Calorimeter (DSC)
  • Thermo Gravimetric Analyzer (TGA)
  • Atomic Absorption Spectroscopy (AAS)
  • Gas Chromatograph with FID & Mass Spectrometer (GC-MS/MS)
  • Preparative HPLC
  • Rheometer, Texture Analyser, Brookfield Viscometers (RV & LV)

We use cookie to improve your experience on our site. By using our site you consent cookies

View more