Our Manufacturing Facilities
Our state-of-the-art facilities are designed for aseptic fill-finish, lyophilization, and high-potency containment, compliant with US FDA
East Windsor, New Jersey
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Facility in East Windsor, NJ with 400,000 Sq. Ft on a linear basis with 45 ft ceiling.
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Buildable space is 1.2M+ Sq Ft
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20 sterile filling lines in isolators planned -
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Cartridges
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Vials
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PFS
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Multi-chamber IV bags
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Located on a 35-acre plot
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Each sterile manufacturing suite will have a separate FEI number
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Total Capacity: 900+ M annual units
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Automated pen and auto-injector assembly lines
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Dedicated analytical and micro labs to release the product within each sterile manufacturing suite
Pearl River, New York
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Two ex-Pfizer/Wyeth buildings at Pearl River, NY, having three floors with a built-up area of ~83,000 sq. ft.
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Five operational lines with filling isolators, capabilities include:
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Sterile dry powder vials
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Solutions and suspensions in PFS
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Solutions and suspensions in Vials up to 250 mL
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Sterile ophthalmic solutions and suspensions
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Segregated and dedicated Manufacturing Suites having flexibility to manufacture multiple products at the same time.
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Utilities having redundancy and backup such as WFI 12,000 liters per day, a total of 10 AHU’s, Generators, Clean Steam, Chillers etc.
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Walk In storage rooms for holding materials at ambient and 2-4°C. Steris tunnel and tray washers (#3), Steris Autoclaves (#5), Compounding Rooms (#4) having multiple SS tanks ranging from 50L – 1000L. All the compounding tanks are connected to SIP/CIP system
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Manufacturing rooms having modular clean room panels, dedicated man/material entry and exit and utility connections.
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Analytical Lab having HPLC’s, UPLC’s, LC/MS, GC/MS, FTIR, Disintegration apparatus etc.
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Microbiology Lab having Sterility test Isolator, KTA for BET test, HIAC particle counters etc.
