The heart of Puniska

Research & Development
Puniska's passion for innovation is fueled by a state-of-the-art R&D center that is spread over an area of 10,000 sq. ft. With the expertise of over 40 scientists, we are working on life-saving injectable products that are designed to regulate in global markets such as USA, UK, Germany, France, Italy Spain, Australia, South Africa, Brazil, and Mexico.
R&D enables us to successfully undertake pre-formulation development, formulation development, reformulation, stability studies, pre-clinical & clinical supplies, process development and optimization, plotting and scale-up validations. As a startup Puniska has invested $4M in research & development infrastructure and houses equipment such as LCMS, GCMS, ICPMS, lab scale lyophilizer, and bag filling machine among others.
Our Key focus:

  • Analytical R&D is to develop and validate methods and evaluate extractable and leachable under 21 CFR compliance environment while maintaining the Data Integrity Policy through Development Quality Assurance (DQA) and Good Laboratory Practices (GLP).
  • Method Transfer, Method Equivalence, Method Verification and Method Validation according to regulatory requirements.
  • ICH stability studies on dosage forms according to regulatory requirements.
  • Cleaning Validation as per systematic approach with regulatory requirements.
  • Chiral Analysis for Isomeric Impurities
  • Residual Solvent Analysis by GC-HS.
  • Impurity profiling with sophisticated technology i.e. LC-MS/GC-MS/IC-MS

R & D Team

Puniska Healthcare has made a robust investment in building a world class research center for our expert team. We boast of highly qualified, experienced, and skilled research staff. We have over 40 highly qualified professionals with specific skill sets.
The analytical R&D team consists of scientists with expertise in areas as varied as Method Development, Method Validation, Superior Analytical Evaluation and Problem Solving Abilities.
Our Research and Development facility operates with latest innovative technologies like lyophilizers- with control nucleation technology, Freeze Drying Microscope, Polarizing Microscope and High Pressures Homogenizer. We also own advanced Analytical Instruments like LC-MS, ICP-MS, GC-MS, HPLC/UPLC, Zeta sizer and FT-IR with 21 CFR compliance.
The state-of-the-art machinery and equipment will assure fast and successful results at all stages of product development.

Formulation Development

Our capability spans over the development of different products such as terminally sterilized, aseptically prepared and lyophilized drugs. Our core strength lies in our ability to excel in developing generic and technologically complex products through the team focused on formulations. Our key focus is to develop generic injectable dosages which meet the global regulatory requirements.
Areas of Expertise:

  • Injectable solutions (Small volume parenteral)
  • Injectable solution (Large volume parenteral in infusion bag)
  • Injectable emulsions
  • Lyophilized powder for injections
Through our products, we will be addressing a potential market of $3.86 Billion. With such a huge market to cater to, we look forward to a journey full of opportunities, hard work and success.

Regulatory

All the regulatory work is handled by a team exclusively dedicated to it. Our well versed regulatory team supports in multiple areas
  • Dossier compilation
  • e CTD Dossier submission
  • Handling regulatory queries
  • Meetings with Regulatory agency for pre- ANDA and Queries
  • Supporting regulatory audits and approvals
  • Post approval changes