Piramal Pharma Solutions invests in expanded potent and non-potent API development and manufacturing at its Riverview, MI facility.
Piramal Pharma Limited's Pharma Solutions business will expand its contract development and manufacturing organization (CDMO) facility in Riverview, MI with additional capacity and new capabilities for API development and manufacturing, the company announced in a Dec. 8, 2020 press release. The company will invest approximately $32 million in the facility and expects that the expansion will be ready for manufacturing in the summer of 2022.
The expansion of more than 25,000 ft2 will include 8500 ft2 of production space and will add new reactors capable of handling up to 4000 L. The company will also add two new kilo labs for process development and GMP manufacture for clinical trials at scales up to 100 L. New equipment includes a filter dryer with glovebox technology and reactors designed to handle potent compounds with OELs of more than 1 mcg/m3. The facility will be designed for safely handling potent compounds.
Source: Piramal
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
April 30th 2024In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.