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

Infrastructure » API Block (2600 Sq.M, 26KL) » Formulation Block (2000 Sq.M) » QA/QC block » Utilities blocks with all necessary infrastructure » Dedicated and spacious ware-houses for API and formulation facilities (as per cGMP) » 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 to have 2 more API blocks (5800 Sq.M) and an additional formulation block (3000 Sq.M)

Partnership Avenues Contract Manufacturing » Manufacturing a product exclusively for a client » SMS to manage all requirements and facilities » To work on cost and process optimization in parallel

Joint venture » Open for JV with MNC’s to complement its strength in this project (for phase II expansions) » Strategic tie-up with MNC’s having strong marketing presence » SMS to collaborate to leverage opportunities in the fast growing oncology segment

*Further details on products, pipeline, and facilities can be furnished on request

Infrastructure API Production blocks » Separate lines to manufacture 2 products simultaneously » Can cater to wide range of processes and products » Dedicated AHUs to prevent cross contamination » Isolator barrier technology is used for safety and minimizing operator exposure levels

Equipment » Reactors (GL, SS) (22.6 KL in total) » ANFD » Isolators » Sifters » Millers » Dedicated HVAC system » Blenders » Vacuum tray driers etc.

Formulation Block » As per cGMP guidelines » Can cater to a wide range of processes /products including Lyophilized injections, Liquid injections, Tablets and Capsules » Dedicated AHUs to supply temperature /humidity controlled filtered air as per requirement

Equipment (Injections) » Lyophilizers » Isolators » LAFs » Water System » Pure Steam Generator » HVAC System » HPHV Steam Sterilizer with Bung Processor » Sterilization and Depyrogenation Tunnel » Vial - Filling, Sealing, Inspection, Labeling and Packing line etc.

EQUIPMENT (TABLETS & CAPSULES ) » Isolators » Tablet Granulating /Processing equipment » » Tablet Compressing machine » Tablet Coating machine » Capsule Processing, Filling, Labeling, Packing line etc.

QA /QC Block » Dedicated QA /QC block » Wet Lab, Instrumentation Lab, and Microbiology Lab are fully equipped to carry out intermediate, in-process, and final product analysis » Qualified team to maintain cGMP compliance and documentation

EQUIPMENT » PLCs » GCs /GC with Headspace » IR & UV Spectrophotometers, » FTIR, » TOC Analyzer » LBPC » Polarimeter » Mili-Q-Water System, » On-line Air-borne Particle Counter » Clean Room Validation Equipment etc.