Home
Contact Us
Webmail
Search:
Home
Company
Company
About Us
Board of Directors
Key Management
Vision and Mission
Awards & Accomplishments
Gallery
Manfacturing
Overview
Existing API Manufacturing Facilites
Dedicated Oncology Facility
Current API Expansion
Contract Manufacturing
Quality Control
Regulatory Affairs
Safety Health and Environment
Research & Development
Overview
Research Facilities
Contract Research
R&D Pipeline
IP/Patents
Products
Overview
API
Intermediates
Pipeline
Enquiry
Investors & Financials
Financials
Code of Conduct
Annual Report
Presentations
News
Press Releases
News
Events
Careers
Overview
Current Openings
Apply for Position
Contact Us
Contact
Partner with us
Manufacturing
Overview
Existing API Manufacturing Facilites
Dedicated Oncology Facility
Current API Expansion
Contract Manufacturing
Quality Control
Regulatory Affairs
Safety Health and Environment
Current API Expansion
Overview
»
Multipurpose API manufacturing facility in 400,000 Sq.m near Vizag, India (to come up in two phases)
»
construction in 400,000 Sq.m near Vizag, India (to come up in two phases)
»
Facility designed to cater to diverse and specialized CRAMS needs of customers
»
Facility meets WHO GMP requirements and is FDA approvable
»
To emerge as one of the best facilities in India upon completion
»
Capability to manufacture 8 products at a time in Phase I from a product mix of 16 products
Salient features
Designed by experts -
Designed by experts with significant experience in bulk drug manufacturing, regulatory audits, CRAMS and pharma MNCs
Regulatory compliance -
Designed as per cGMP guidelines and is suited for FDA /other approvals
Flexibility -
Avenues for customizable and scalable offerings
Support infrastructure -
Equipped with QA/QC blocks, ware-houses, services and other support infrastructure
Special reaction blocks -
Special blocks for reactions like dry reactions, catalytic reductions, corrosive reactions, high vacuum distillations, solvent recovery, and pilot scale up
Quality and EHS standards -
Quality and safety integrated into operations and facility has an in-house ETP and a pipeline route to sea for disposal of treated effluents
Phase 1 – OVERVIEW*
Production blocks
2 FDA standard production blocks (Type A)
3 cGMP intermediate blocks (Type B & C)
Built up area – 36,286 Sq.m
Total reactor volume – 412 KL (range 1-8KL)
No. of API’s finishing area (of class 100K (ISO 8)) in each block: Type A – 4, Type B – 2
Equipment in each block includes dryers, filters, millers, blenders, etc. and has provisions for specialized equipment based on requirements
QA/QC blocks (2)
Wet lab, instrumentation lab and microbiology lab are fully equipped for intermediate, in process, and final product analysis
Service blocks (2)
These blocks in the facility are well equipped to ensure dedicated and self sufficient services for each production block
Ware-houses (4)
As per cGMP standards
Solvent storage tanks area (separate area for explosive storage tanks)
Environment, health and Safety
»
Effluent treatment plant and dedicated pipeline to sea for treated effluents
»
Equipped with fire hydrant systems
»
First aid center to be maintained 24/7 by paramedical staff
»
ISO 14001 and OSHAS 18001 certifications expected
»
Regular monitoring by EHS department