Piramal Pharma Solutions (PPS) is expanding its manufacturing facility in Riverview, Michigan, investing approximately US$32 million in the development and manufacture of potent and non-potent active pharmaceutical ingredients (API).
Piramal Pharma Solutions (PPS) is expanding its manufacturing facility in Riverview, Michigan, investing approximately US$32 million in the development and manufacture of potent and non-potent active pharmaceutical ingredients (API).
The expansion was announced in December 2020 and will include innovation capabilities and the addition of new laboratories and large-scale manufacturing capabilities.
The expansion project will be completed in June 2022. It will add about 20 new workers to the facility, increase the total number of employees to more than 180, and will support the regional economy.
PPS's API manufacturing plant is located in Claus Street, Riverview, Michigan, and is well-known for the manufacture of high-efficiency active pharmaceutical ingredients (HPAPI).
The facility will be expanded by more than 25,000 square feet, including 8,500 square feet of production area of the existing facility.
It will install a new 4,000-liter reactor and add two new kilo-scale laboratories for process development and GMP manufacturing for clinical trials up to 100-liter scale.
Other key equipment, including a 1 square meter filter dryer with glove box technology, 3KL and 4KL mild steel glass-lined reactors, and 3KL Hastelloy reactors will also be added to the facility. All devices are designed to handle potent compounds with occupational exposure levels (OEL) exceeding 1 microgram/m3.
The design of the facility incorporates all necessary measures for the safe handling of highly efficient compounds, including controlled room pressurization and air locks for the safe movement of people and goods, scrubbers and glove box technology for any exhaust reaction or for charging Close the system and discharge the powder.
This expansion will enable the company to meet consumer immediate and long-term API needs, thereby expanding its foothold in North America. It will enhance the company's ability to provide high-quality active ingredients to all parts of the world in a timely manner.
This expansion marks the company's seventh major acquisition or expansion in North America in the past six years.
PPS’s Riverview facility complies with regulatory requirements, including those set by the U.S. Food and Drug Administration (FDA) and several European and Asian government agencies. It maintains high standards in terms of health, safety and environmental sustainability.
The most advanced Riverview factory is dedicated to manufacturing low OEL HPAPI.
It is equipped with a 4,000-liter glass-lined reaction vessel that can operate in the temperature range of -70°C to 200°C, an efficient manufacturing kit with airlock and barrier isolation system, and a reactor compartment for large HPAPI.
The site has product insulation functions, including extraction, filtration, centrifugation and distillation, as well as drying and finishing functions, including closed Rosenund glove box filter dryers, forced ventilation and vacuum drying ovens, and a class 10,000 clean room.
The company runs 12 hours a day, 7 days a week, and is moving towards becoming a complete 24/7 site. The agency has 15 U.S. Food and Drug Administration (FDA) approvals and is in breakthrough status, orphan disease, and fast track Have experience in approvals.
The website also provides special services such as process research full-time equivalent (FTE), optimization, commercial API and HPAPI manufacturing, safety assessment, impurity identification, characterization and synthesis, solid-state characterization, analytical method development, validation and verification.
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