Manufacturing Facilities

World class cGMP manufacturing Facility

Manufacturing Facility Key Highlights:

Salient Features:

Large scale manufacturing facilities ready to deliver small to large scale molecules in quick time

    • Reactor Capacity: 120 KL capacity; (200KL green field expansion planned for 2026)
    • Installed Production Capacity: 2400MT of various products (per annum)
    • Equipment Details: Reactor Sizes ranges from 0.63KL to 8KL; filtration and drying equipment like centrifuge, ANFD, VTD, milling equipment
    • Temperature Range: -20 °C to + 220 °C

CERTIFICATIONS

USFDA
PMDA
ISO

Purogene Site Compliant with Key Global Regulatory Bodies

LEADERSHIP EXCELLENCE

Managed by Leaders with 14+ Successful USFDA Audits in SMS Group

Majority Audits: ZERO 483's

(Signifying full compliance, no major observations)

OUR COMMITMENT

  • Current Good Manufacturing Practices (cGMP)
  • Applicable Regulatory Requirements
  • Continuous Quality Improvement
Ensuring Purity, Safety & Reliability

Stringent operating procedures and compliance to current Good Manufacturing Practices (cGMP) and applicable regulatory requirements

    • Purogene Site Compliances: USFDA, PMDA, ISO
    • Managed by leadership who have successfully completed 14+ USFDA audits in the SMS group. Majority of the USFDA audits were closed with ZERO 483’s.

Continuous investments in upgradation of manufacturing facilities with emphasis on deploying advanced machinery and adopting latest technologies

    • Completely closed loop manufacturing and automation of complexand difficult molecules like Ranitidine production from starting to end with minimal manual intervention to improve quality and safety.
    • Embarked on implementing industry 4.0 technologies that can help create more efficient and productive factories,better schedule deliveries and reduce lead times, make more informed decisions about resource allocation and product delivery