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Shasun Pharmaceutical Division develops and manufactures formulations for solid dosage products. The Division is a vertically integrated formulations partner for the pharmaceutical industry. Its services include formulation research and development activities, Analytical method development and validation, scale-up and technology transfer, clinical supplies manufacturing to full scale commercial manufacturing of oral solid dosage forms.
The formulation facility is located in Puducherry, in the south eastern coast of India. The site is located on a 14 acre campus with plenty of room for future expansion.
It is a new facility completed in 2006 with 100,000 square feet of constructed space. It contains office areas, analytical laboratories, formulation development laboratories, a cGMP pilot plant and commercial manufacturing space. The facility is built to meet the regulatory requirements of the US FDA, Health Canada, MHRA in the U.K and other European Agencies.
Some of the key features include separate air handling units with terminal mounted EU13 HEPA filters, to provide a class 100000 environment in the manufacturing areas. These are continuously monitored by a building automation system. Tablet compression areas have vertical material flow to avoid cross contamination. Automatic container cleaning system ensures validation of cleaning procedures.
The facility has limited access controls and CCTV monitoring of man movement to various areas inside the facility, to avoid violation of current Good Manufacturing Practices (cGMP). |
