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Quality system designed to meet global standards

Our quality system is designed to meet the most stringent global regulatory standards. This enables us deliver products that consistently meet the expectations of the markets we serve, particularly US, EU and Japan. We ensure quality through a robust governance framework encompassing our facilities, people, procedures, and our value system that emphasises on integrity and continuous improvement.

GMP for commercial products

Our quality system is designed in adherence with USFDA, EU, TGA and ICH guidelines, 21 CFR Part 210 and 211 and Indian cGMP standards (Schedule M), for manufacturing registered intermediates and commercial APIs.

Phase-appropriate GMP

During the development phase of a molecule, the process and test procedures for manufacture of intermediates and APIs need to be flexible. We have established quality principles that are phase-appropriate and comprehensive for the manufacture of molecules with robust scientific methodology.

Our documentation processes are increasingly digital. The entire manufacturing system will be made paperless by March 2020. Taking care of people also means taking care of our planet.

Paperless R&D

The experimental data in our process R&D and analytical R&D functions are being handled through electronic laboratory notebooks. This enables quick retrieval and robust archival of experimental data for several years.

Paperless Manufacturing

A substantial part of our manufacturing process operates electronically through software systems with inbuilt cGMP. It includes transaction modules specifically designed to manage the day-to-day operations in warehouse, production, quality control, quality assurance & engineering departments. With the addition of electronic batch process records, analytical raw data sheets among other related routine processes, the entire manufacturing system will be made paperless by March 2020.

Regulatory approvals

  • R&D centre, Hyderabad, India
    Approved by USFDA
    GMP certified by regional regulatory bodies in India
  • Manufacturing facility, Hyderabad, India
    Registered with USFDA
    GMP certified by regional regulatory bodies in India
  • Manufacturing facility, Bidar, India
    Approved by USFDA
    Approved by PMDA, Japan
    Approved by COFEPRIS, Mexico
    Certificate of Pharmaceutical Product (WHO)
    Written Confirmation from EU GMP
    GMP certified by regional regulatory bodies in India
  • Formulation development, Pune, India
    Approved by USFDA
    GMP certified by regional regulatory bodies in India
  • 600+ successful customer audits