High Containment & Cytotoxic Capabilities
CPS is one of the few service providers to offer a complete solution for high containment and cytotoxic compounds from API development and manufacturing to development and commercial manufacturing of the finished product.
For API development and commercial manufacturing of highly potent and cytotoxic compounds, Dr. Reddy's has 2 facilities, one in Hyderabad and one in Vizag, India to handle products with Occupational Exposure Limits (OEL) of 0.2µg/m3 for 8 hours.
For commercial manufacturing of highly potent and cytotoxic finished products, Dr. Reddy's has capacity for 80 million units, and 6 million for sterile vials (both SVP and Lyophilized powder in vials (OEL of 0.1µg/m3, both of which can be readily expanded. Production capacity ranges from 25kg up to 2500kg API formulation per year in each of the suites.
For Dosage Development, dedicated laboratories are available at FTO-2. In combination with Dr. Reddy's cytotoxic API manufacturing capabilities, we offer a unique and integrated development and manufacturing solution for cytotoxic oral solids and parenterals (liquid and lyo).
A recent addition to our dosage capability is a high precision Xcelodose capsule filling machine, contained in an isolator. Very small quantities of cytotoxic powder (as low as 100µg and greater than 100mg) can be filled with extreme precision into capsules suitable for cGMP clinical supplies. This technology can improve product quality and significantly reduces cost and time in the pharmaceutical development process. In addition, the quantity of API required is minimal. Another building on the same campus offers high potency (non-cytotoxic) oral solid products (OEL of 0.1µg/m3) with a capacity of approximately 40m units.
