R and D

Research and Development

R&D Policy:

To Develop Drug Products with an emphasis on Integrity, Quality, Process Robustness and Stability at an affordable cost to the patients world-wide, in alignment with organizational goals and objectives.

TEAM : 

KAPL Research and Development Team is championed and mentored by Managing Director.

Under her leadership and vision, the Formulation Development has evolved into a Research and Development Unit, to align with organization’s mission.

Team R&D comprises of Formulation, Analytical and Packaging Development Scientists with expertise to develop, optimize and analyze various drug delivery systems.

KEY ACTIVITIES : 

  • Evaluation of new technologies for effective drug delivery systems
  • Interface with marketing group to identify, develop and launch new drug products for domestic and international markets
  • Literature survey as part of Product and Analytical Development
  • Product Development Cycle
  • Analytical Development Cycle
  • Stability Studies
  • Develop specifications for drug substances, excipients, primary and secondary packaging materials and finished drug products
  • Develop Label and product insert artworks
  • Identification of Critical Manufacturing Attributes as part of Risk Evaluation and Mitigation
  • Preparation of Product Development Reports, Bill of Materials, Standard Manufacturing protocols
  • Technology Transfer
  • Interface with QA as Subject Matter Experts in Process Validation
  • Interface with Regulatory groups for filing of new applications for approvals
  • Interface with various groups as Subject Matter Experts for change control which impacts, process and product attributes
  • Interface with Works group as part of making the manufacturing process robust as part of continuous improvement
  • Vendor evaluation
  • Analytical method development for drug product
  • Stability studies to support development and regulatory fillings of drug product
  • Cleaning methods for drug products
  • Method transfers

DRUG DELIVERY SYSTEM : 

  • Oral Solid Dosage Forms: Tablets, Capsules and Powders
  • Liquid Orals: Ready-to-use solution/suspension
  • Parenterals
    • Dry Powder Parenterals
    • Small Volume Parenterals
  • Topicals: Ointments, Creams, and Gels
  • Ayurveda (Herbal) Formulations

CAPABILITIES:

Formulation Process Capabilities Analytical Process Capabilities
  • Rapid Mixer Granulator
  • Fluid Bed Processor
  • Under driven Conical Mill
  • Tableting Machine
  • Tablet Coating Machine
  • Homogenizers
  • Capsule Dosing Machine
  • Propeller Stirrer
  • Blender Bins
  • High Performance Liquid Chromatography
  • Dissolution Testing Apparatus with Auto sampler
  • Viscosity Measurement
  • UV-Visible Spectrophotometry
  • Photo Stability Chamber
  • Stability Chambers
  • Hardness Tester
  • Disintegration Apparatus

FACILITIES:

HPLC

R&D_HPLC Agilent

Granulation Suite

R&D Granulation Suite

Tablet Coating

R&D COATING MACHINE

Dissolution Apparatus

R&D Dissolution Apparatus