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
- 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
ANALYTICS
- 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
Dosage forms developed and manufactured
REGULATORY STRATEGY
- 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)