API Manufacturing

API Manufacturing:

Highlights of the Process adopted to meet our Goal

  • Since Oncology APIs are highly potent, a methodology of handling materials in line with requirements of a high-containment facility has been adopted: starting from active RMs & API sampling to dispensing.
  • Extensive use of Active/Passive valves at various stages of the process to achieve the objective of high-containment.
  • A robust technology transfer from state-of-the-art R&D Centre located at Bhiwadi, Rajasthan.
  • An in-house state-of-the-art QC laboratory comprising QC Chemical & QC Microbiology set up at SRL.
  • A world-class material storage facility at our Warehouse for APIs / Excipients / Packing Materials / In-Process FG quarantine / FG Store (Area 2000 sq. metres).

Ensuring Total Absence of Cross Contamination


  • Dedicated manpower for oncology & non oncology API production.
  • Entry controls in production blocks such as allowing only authorized personnel.
  • Adequate training by QA to personnel of Production, QC, Engineering and other Departments to prevent cross-contamination.


  • In oncology production facility, air showers provided for entry & exit of personnel.
  • Different gowning procedure provided for oncology & non-oncology production facilities.
  • For oncology products manufacturing, facility provided for material isolation inside the isolators.
  • Uni-directional movement of men & materials to avoid the cross contamination.
  • Dedicated production blocks for oncology & non-oncology products.
  • Dedicated QC labs provision for analysis of oncology & non-oncology products.
  • Detoxification of tools & samplers/waste in oncology production facility.
  • Dedicated vacuum systems available for oncology & non-oncology production facilities.
  • Dedicated storage facility for oncology & non-oncology APIs in warehouse.
  • Environmental monitoring for oncology & non-oncology production facilities