Vivek Sharma CEO Piramal Pharma Solutions

Vivek Sharma, chief executive officer of Piramal Pharma Solutions (PPS), a contract development and manufacturing organization, outlined an ongoing approximate $90-mllion investment plan to support expansions in its drug-substance and drug-product development and manufacturing capabilities. Sharma spoke at the DCAT Week ’18 Member Company Announcement Forum, which was held Monday, March 19, 2018 in New York.

Sharma specified that the company is investing approximately $60 million to expand active pharmaceutical ingredient (API) development and manufacturing capabilities at its sites in Riverview, Michigan; Morpeth, UK; and Ennore and Digwal, India. On the drug-product side, the company is investing approximately $30 million to expand drug-product development and manufacturing at its site in Lexington, Kentucky and Ahmedabad, India.

PPS has 12 R&D and manufacturing sites across North America, Europe, and Asia, which support approximately 110 programs in late-stage clinical development. Sharma said that a number of these programs represent integrated partnerships to support both drug substances and drug products. To meet demand from these programs and to address future needs, Sharma outlined the company’s expansion activity. These investments include:

• Extending the high-potency active pharmaceutical ingredient (API) capabilities at its facility in Riverview, Michigan to meet potency requirements of up to 10 ng/cubic meters;
• Adding 270 kL of API capacity in a new facility in Digwal, India, to support near-term launch requirements for several programs;
• Adding two lyophilizers and commercial, high-speed vial fills to a new dedicated sterile-injectable manufacturing suite in Lexington, Kentucky, which triples the fill/finish capacity and quintuples lyo capacity;
• Retrofitting the company’s facility in Morpeth, UK with two new large-scale reactors for APIs, a filter dryer, a dedicated yellow-light chemistry laboratory and new analytical instrumentation to support a new product launch;
• Expanding the company’s facility in Ennore, India, to support early API development by adding a new GMP kilo laboratory and pilot-plant capabilities; and
• Expanding drug-product capabilities at its facility in Ahmedabad, India to support integrated clinical development programs.