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INFRASTRUCTURE

FACILITIES & INFRASTRUCTURE

The manufacturing facility is established and operates strictly as per international regulatory standards and has all the necessary infrastructure and services of a modern and multipurpose pharmaceutical bulk drugs [API] and Intermediates manufacturing plant.

The facility is supported by an efficient Quality control and quality Assurance Department. Storage, Maintenance and Transportation services are adequately available. Close supervision coupled with a dedicated team of technical and commercial professionals ensure that all operations are reliable, flexible and pursue excellence in quality.

The manufacturing plant has adequate land, Production Area and Storage area with equipped all modern machinery, Equipment & Instruments.

Our manufacturing facility is designed as per USFDA, EUGMP, schedule M, ICH and other regulatory norms.

The layout of facility is guided by a "Quality by Design" master plan. The location of various buildings, roads & Green zones are well defined.

The State-of-the-art facility stands on 16 acres of land and covers the following installations :

  • Research & Development Laboratory

  • Quality control Department

  • Quality Assurance & Regulatory Affairs Department

  • Manufacturing Blocks

  • Engineering Department with in-house fabrication workshop

  • Separate Warehouse for Raw materials and finished goods

  • Utility Buildings

  • Solvent, Acid, and Alkali Storage

  • Generator building


PRODUCTION

All Manufacturing blocks are designed as per cGMP and regulatory norms.

  • Production Block-1: Biological API Manufacturing Block

  • Production Block-2: Low volume high value API Manufacturing Block

  • Production Block-3: Bulk intermediates Manufacturing Block

  • Production Block-4: Bulk intermediates Manufacturing Block (high pressure, factional distillation, hydrogenation and high temperature Reactions)

  • Production Block-5: Biological Parental Preparation Block (injectable especially Pre-Filled syringes manufacturing block) Designed as per regulatory
    norms EUGMP & USFDA.

UTILITIES

  • Boilers

  • Thermopack Boilers

  • Brine Plant

  • Chilling Plant

  • Zero torr vacuum

  • Cooling Towers

  • Air Compressors

  • Nitrogen Plant

  • Water Purification Plant like RO, DM, wfi & Purified Water

  • DG set for power backup

  • Complete ETP facility for Zero discharge

ENGINEERING

Well-organized GEP procedures, experienced technical team, facilities for engineering materials warehouse, fabrication and maintenance workshop, well-designed centralized utilities and power backup generators.

WAREHOUSE

Warehouse covers for the handling of all incoming raw materials, packing materials and finished products with pre-defined storage conditions. Facilities for the handling of gases, hazardous chemicals and solvents independently.

TECHNICAL EXPERTISE

Our technical expertise is to convert & use eco-friendly & cost-effective process technology with standard impurity profiles through the avoidance of costly solvents, milder reaction conditions, use of hazardous reagents and lower waste streams.

Our teams at Prudence have experience in a wide range of chemical processes including conventional and catalysed reactions.