Pilot Scale Manufacturing FDF

PharmaZell (Vizag) operates a pilot plant for formulations to

  • Ensure technology transfer from Lab development to Pilot/ Pivotal scale up, inline simulation to commercial scale production
  • Produce formulations Exhibit/ Submission/ Pivotal batches under cGMP for BA/BE studies
  • Conduct stability studies as per the ICH and regulatory requirements
  • Manufacture small scale commercial batches (high value products, which are usually required in small batch sizes).

We contribute a scale-up experience which guarantees the process optimization as per all regulatory guidelines with all safety and efficiency aspects.

Key characteristics of Pilot/Pivotal Plant

  • The Facility is a class 1,000,000 area with a cGMP compliant documentation and equipment
  • Separate well-equipped and demarcated rooms as material hold area, granulation area, compression room, a coating room, IPQC room, primary and secondary packaging room and wash area.
  • Capable of taking up batch size up to 15 kg to 75 kg.
  • Capable of wet/dry granulation, direct compression, film coating and blister/strip/alu-alu packing of oral solid dosage finished products.
  • Analytical method validations.
  • Validation studies for Pilot/ Pivotal
  • Dossier registration support to all regulated and ROW markets
  • Product launch after patent expiry
  • Absolute focus on Safety, Health & Environment
  • Having space for new/ novel drug delivery systems like technology platforms (modifier release, delayed release, dry syrups)