Press Release Overview
On September 30, 2026, Piramal Pharma Solutions (PPS), a contract development and manufacturing organization (CDMO) within Piramal Pharma Ltd (NSE: PPLPHARMA, BSE: 543635), announced that it and nonprofit generic drug maker NP2 will complete the development phase of the generic sterile injectable oncology drug cyclophosphamide in October 2026. The development and subsequent manufacturing activities are being carried out at PPS’s dedicated sterile injectable facility in Lexington, Kentucky.
Market Context and Shortages
A National Comprehensive Cancer Network (NCCN) survey of member institutions conducted in late August reported that 100% of respondents are experiencing a shortage of at least one anti‑cancer agent, with more than 20% of centers facing shortages of five or more cancer medicines. Cyclophosphamide is among the drugs in short supply in the European Union and Canada. In the United States, the two leading cyclophosphamide manufacturers, both located overseas, together account for 92% of total sales, and one of them supplies nearly 70% of the U.S. 200 mg ready‑to‑use solution market, according to Q2 IQVIA sales data.
Facility Expansion and Capacity Building
The Lexington site is undergoing an $85 million expansion designed to increase manufacturing capacity for cyclophosphamide and similar products. This investment is intended to shorten and simplify the supply chain between the plant and U.S. cancer patients, thereby reducing reliance on overseas manufacturers.
Timeline to Market
NP2 expects the ready‑to‑use sterile injectable form of cyclophosphamide to reach the U.S. market in mid‑2028, providing a domestically produced, stable‑price source for oncologists and patients.
Executive Statements
Telly Athanasopoulos, Head of Manufacturing at NP2, described the move to manufacturing in the United States as “good news for cancer patients and their doctors, who need a safe, reliable supply of cyclophosphamide at stable prices.” Peter DeYoung, CEO of Piramal Global Pharma, highlighted that the Lexington expansion “builds a more resilient domestic supply chain and helps support reliable access to this essential cancer therapy.” Terri Miller, Executive Director of NP2, emphasized that the shortage issue is “about the system” and that a reliable U.S.-made supply of cyclophosphamide “does not exist today,” underscoring the partnership’s role in addressing this gap.
About the Companies
Piramal Pharma Solutions offers end‑to‑end development and manufacturing services across the drug lifecycle, operating a global network of facilities in North America, Europe, and Asia. Piramal Pharma Ltd comprises PPS, Piramal Critical Care (hospital generics), and Piramal Consumer Healthcare, with a presence in over 100 countries. NP2 is a nonprofit focused on building a reliable, affordable, and resilient supply of life‑saving medicines, beginning with cyclophosphamide.