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Manufacturing
Overview
Existing Facilites
Dedicated Oncology Facility
Overview
Infrastructure
New Multipurpose API facility
Contract Manufacturing
Quality Focus
Regulatory Submissions
Environment, Safety & Health
DEDICATED ONCOLOGY FACILITY
OVERVIEW
State of the Art manufacturing facility (API and formulations) for Oncology and high potent products in compliance with international standards, to come up in two phases (with containment measures)
It is a FDA approvable facility located in 40,500 Sq.m area in JN pharma city in Vizag, India
Can cater to a wide range of processes / products including Lyophilized injections, Liquid injections, Tablets and Capsules
Isolator barrier technology is used for safety and minimizing operator exposure levels
Dedicated AHUs to prevent cross contamination
Facility well positioned to cater to contract manufacturing and joint venture partnerships
Decorative furnish
Building advice
Development of scripts
Accommodation of clauses
SALIENT FEATURES (PHASE 1)
API Block (2600 Sq.m, 26KL)
Formulation Block (2000 Sq.m) (currently under construction)
QA/QC block
Utility blocks with all necessary infrastructure
In house ETP supported by common effluent treatment plant and hazardous waste management system in pharma city, Vizag
Integrated health and safety measures
Phase 2 - Two more API blocks (5800 Sq.m) and an additional formulation block (3000 Sq.m) are planned