Scope


RAW MATERIALS:
To best cater the complexities of the pharma production procedures and to have a stable formulation, our efficient Technical Sales Team helps our clients in choosing the correct source of raw materials, having the desired technical specifications.

    Our Strength:

  • Technology Development Centre in India with focus on new APIs with non-infringing process development.
  • Technology transfer from Lab to Plant.
  • Highly qualified team for Process and Analytical Development,Experienced Regulatory and IPR Team.
  • Emphasis on QMS complying to ICH Q7A GMP guidelines, 21 CFR Part 210-211 and WHO GMP.

Over the years we have partnered with some of the best names in the International Pharma Industry to provide our customers with consistent and customized:-
1. ACTIVE PHARMACEUTICAL INGREDIENTS - APIs
2. PELLETS
3. EXCIPIENTS


    Services:

    Our Capabilities for services in API & Formulation Business:-

  • Cost Effective Process Development & Manufacturing APIs & Intermediates.
  • Documentation for Technology Transfer (TT)
  • Quality Assurance System establishment in organization & providing services for QA along with Regulatory Filings (DMFs / ANDA)
  • Contract Research Projects

  • CRAMS Product Development in case of APIs and Formulations are done in the below sequence of operations:-

  • Selection of molecule (information from client) followed by Literature Survey.
  • Selection of ROS followed by Technical and then Commercial Proposal.
  • Preparation of Protocol and approval from client.
  • Development of the product as per timelines meeting technical specifications.
  • Analytical method development and analysis.
  • Compatibility Studies to be done (in case of formulations)
  • Stability Program Management & Analytical Method Validation.
  • Product Development Report (TT) and Product Transfer.