Research & Development Facility

The company is having a well equipped state of art R & D centre with five independent laboratories and consisting of more than 40 qualified scientists with extensive expertise and experience in process Research and Development activities for APIs and their critical intermediates.

The R&D strengths are development of non-infringing, novel, cost effective routes to comply with IP and regulatory requirements in safe and environmental friendly processes for APIs and critical intermediates.

Have the strong expertise and experience in asymmetric synthesis and in resolution and racemization chemistry to develop chiral molecules. Skilled in polymorphism associated with new molecules development.

R & D capabilities include peptide synthesis, heterocyclic reactions, reductions & oxidations, Grignard reactions and also reactions involving n-Buli, LDA, NaH, BH3-BF3, BDMS, DIBAL and Vitride.

Focus on backward integration thereby having full control on cost and quality of APIs and sustainable support.

The R&D centre is supported by strong technology transfer team to study the scale up issues before commercialization. We adopt good laboratory practices with online documentations for various phases of process development including the scale-up which help production to have a safe and robust process and to support regulatory filings along with evolution of genotoxic impurities and synthesis and characterization of process/degredation impurities.

The R & D centre is recognized by Department of Science and Technology, Government of India.

Analytical development:

The R & D is supported by analytical development laboratory well equipped with modern instruments. Around 10 skilled and experienced people are working with analytical development laboratory for method developments and to support regulatory team, quality control team and to address the regulatory and customer quarries. The analytical development laboratory is equipped with HPLCs and GCs, prep. HPLC, GC-MS, LC-MS, UV, IR, Polari meter, potentiometer, Auto titrate along with other instruments to carryout complete analysis.

    The role analytical development laboratory is :

  • Development and validation of analytical methods for APIs and their critical intermediates.
  • Establish complete specifications and test methods for all raw materials and key starting materials.
  • Conducting stability studies for laboratory samples of APIs as per ICH guidelines to define the storage and packing conditions.
  • Development of methods for genotoxic impurities and their evolution.
  • Development of chiral methods.
  • Impurities isolation by preparative HPLC and evolution.
  • Degradation studies.
  • Documentation of all data in line with current good laboratory practices.