NEW MULTIPURPOSE API FACILITY
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Overview
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First phase of Multipurpose API manufacturing facility in 400,000 Sq.m near Vizag, India completed (to come up in two phases) |
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Facility designed to cater to diverse and specialized CRAMS needs of customers |
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Open for strategic patnerships to collaborate on this project |
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Facility meets WHO GMP requirements and is FDA approvable |
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To emerge as one of the best facilities in India upon completion |
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Capability to manufacture 8 products at a time in Phase I from a product mix of 16 products |
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SALIENT FEATURES
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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 dedicated pipeline to sea for disposal of treated effluents |
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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
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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
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Effluent treatment plant and dedicated pipeline to sea for treated effluents |
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Equipped with fire hydrant systems |
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First aid center to be maintained 24/7 by paramedical staff |
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ISO 14001 and OSHAS 18001 certifications expected |
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Regular monitoring by EHS department |
* First block is phase I has been commissioned recently |
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