API – Facilities

Active CEP (CEP 2006 : 312) for Metformin HCL listed at EDQM since 2008.
Plant WHO GMP and Written confirmation (WC) certified by CDSCO India.

• Plant Certified by TUV SUD for:
  • ISO 14001:2015 (Environment Management Systems)
  • OHSAS 18001:2007 (Occupational Health & Safety Management Systems)
  • ISO 9001:2015 (Quality Management Systems)
• Facilities routinely audited by global customers
• Plant located within company owned complex amidst pristine surroundings.
• Site and processes focused on minimization of environmental impact.
• Dedicated single-product block for Metformin HCL.
• Constantly improved infrastructure including – State of the art cleanrooms, final product handling systems.
• Comprehensive Quality control unit with end to end in-house testing for
  including full fledged microbiology laboratory.
• State of the art computerized testing systems including networked computer systems in full compliance with 21 CFR part 11 / EU annex 11.
• New facilities for R&D, Pilot scale and commercial production of a new portfolio of APIs will be deployed from FY 2021-22.