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IPS

Cytotoxic Commercial Manufacturing

Developed a risk-based approach to design a new 35,000sf manufacturing facility for the production of OSD and parenteral cytotoxic pharmaceutical products located in India.  The new cGMP facility included two dedicated areas; one for oral dosage and the other for parenteral products for international market distribution.  Solid dosage capabilities included wet and dry granulation through compression, coating, and final packaging.  Parenteral operations supported formulation and primary/secondary packaging. Various isolation technologies were assigned to provide for primary containment.  Facility elements provided transition area supporting secondary containment and cGMP zoning (FDA , EMEA, MHRA, WHO). Produced materials will be used for submission and commercial use with batch sizes ranging from 0.75kg to 60kg.

Services included: