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The expansion of the Kentucky site accounts for $80 million of the announced investment, with the remaining money earmarked for facilities in Michigan.
Piramal Pharma Solutions, the contract development and manufacturing organization within Mumbai-based Piramal Pharma, held a groundbreaking ceremony on June 25, 2025, for its new sterile injectables development and manufacturing facility in Lexington, Ky. (1). The new construction in Lexington, as well as in Riverview, Mich., comprise a $90 million investment plan first announced by Piramal Pharma in May 2025 (2).
However, the expansion of the Lexington site accounts for $80 million of that amount, and the Lexington plans had already been announced in September 2024, well prior to the disclosure of the updated May 2025 plan (3).
At the time of the May announcement, Piramal Pharma said it was responding to what it called a trend toward onshoring of drug supply in the United States. Earlier that month, US President Donald Trump signed an executive order directing FDA and the Environmental Protection Agency (EPA) to reduce certain regulatory barriers—including urging EPA to accelerate construction of prescription drug manufacturing sites—after which FDA said it intended to expand unannounced inspections at foreign manufacturing facilities (4,5).
Piramal Pharma said its Lexington site is designed to be the company’s dedicated fill/finish facility, providing fill/finish services for all integrated programs and specializing in sterile compounding, liquid filling, and lyophilization for sterile injectable drug products (1). The expansion, which is expected to be completed by late 2027 and which will eventually create 40 new, full-time jobs, will accommodate commercial-scale sterile injectable manufacturing with 24,000 additional square feet, plus a new laboratory, and state-of-the-art machinery: a new filling line, specialized capping machine, external vial washer, and two commercial-size lyophilizers.
As such, the Lexington site will more than double its manufacturing capacity upon completion of the expansion, from a current peak utilization of 104 product batches annually to more than 240, according to Piramal Pharma (1).
“We prioritize patient, consumer, and customer centricity in all our operations, engaging with the populations we serve to better understand, anticipate, and address their needs,” Nandini Piramal, chairperson, Piramal Pharma, said in a company press release (1). “Our research has revealed that the sterile injectables market is projected to exceed $20 billion by 2028, underscoring the urgent need for us to enhance our offerings in this segment. We are confident that this strategic $90 million investment will empower us to meet the demands of this market, reinforcing our position as a trusted global partner in biologic manufacturing. By enhancing the services we provide to our partners, we can reduce the burden of disease for more patients around the globe.”
Piramal Pharma said the expansion at the Riverview site is expected to be complete by the end of 2025; at this location, a commercial-scale suite is being added that is specifically designed for development and manufacturing of payload-linkers (1).
1. Piramal Pharma Solutions. Piramal Pharma Solutions Breaks Ground on $90M Expansion Plan. Press Release. June 30, 2025.
2. Piramal Pharma. Piramal Pharma Ltd. Continues to Invest In USA; $90M in Expansions of Two US Sites. Press Release. May 12, 2025.
3. Piramal Pharma Solutions. Piramal Pharma Solutions Announces $80M Expansion Plan for Sterile Injectables Facility in Lexington, Kentucky. Press Release. Sept. 30, 2024.
4. The White House. Fact Sheet: President Donald J. Trump Announces Actions to Reduce Regulatory Barriers to Domestic Pharmaceutical Manufacturing. WhiteHouse.gov, May 7, 2025.
5. FDA. FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities. Press Release. May 6, 2025.
