The conceptual design was reviewed by the USFDA prior to the commencement of construction. In 2001, ScinoPharm's completed facility was inspected by FDA and given a "suitable" facility rating. Our production facilities consist of 16 units (9 cGMP lines) for production ranging from kilograms to multiple tons. Reactor sizes range from 50 liters to 8,000 liters and materials range from stainless to glassed-lined to hastelloy. Three units are considered large suites, two are intermediate in size and two are considered small units. Four lines are capable of cytotoxic/high potency production with total containment and properly segregated air and physical systems. All nine lines have their own dedicated filtration/drying/milling/and packaging facilities. Several multiple-use drying and finishing units are available to reduce intermediate bottlenecks and all have been validated for API/cGMP operations. All process and utility systems are fully automated using a Fisher Rosemont Delta V process automation system.

USFDA's Establishment Inspection Report Findings (.pdf) Our Kunshan Facility

Tainan, Taiwan Facility
The ScinoPharm® Taiwan 16.5 acre main process R&D and manufacturing facility is located in the Tainan Science-based Industrial Park in southern Taiwan. It is one of the largest non-brand facilities of its kind in the world with more than 200,000 square feet of space and approximately 315 employees. The facility has received satisfactory audit results from 15 major international customers.

The broad array of chemical reactors ranging from very small to very large provide the flexibility to conduct a wide variety of chemical processes. This offers the capability to meet customers' requirements in any size range. All phases of operations will adhere to stringent international quality, environmental, health and safety requirements and will be in full compliance with international cGMP standards.

Kunshan, China Facility
ScinoPharm's second R&D Center is located in Mainland China near Shanghai. It provides process research and, in the future, key intermediates for the Taiwan operations. Currently, there are over 100 employees, with 55 in R&D roles. The facility also includes a kilo lab and pilot plant.