Piramal Pharma Limited’s Pharma Solutions business, a leading contract development and manufacturing organisation (CDMO), has announced that a new production block has come online at the company’s drug product site in Pithampur, in the state of Madhya Pradesh, India.
The new production area, known as V Block, can handle batch sizes of 150 to 600 kg, augmenting the site’s capacity to produce oral solid dosage form drug product.
With the addition of V Block, the Pithampur site’s total production capacity increases from 3 billion doses to 4.5 billion doses. V Block includes aqueous and non-aqueous wet granulation (high shear, top spray and bottom spray), direct, mono and bilayer compression, aqueous and non-aqueous coating, and bottle packaging technologies.
Aggregation capabilities related to US FDA e-pedigree and track and trace requirements are planned for V Block, as is the addition of dry granulation capabilities (roller compaction). Like the other four production blocks on site, V Block has dedicated personnel and material entry with biometric access control for the block and the operating cubicles within it, as well as dedicated air handling unit for each cubicle.
Peter DeYoung, Chief Executive Officer, Piramal Pharma Solutions, said: “The launch of this new large-scale production block represents a significant expansion of our ability to supply oral solid dosage form drug product to customers around the world. This additional capacity further reiterates our commitment to being a patient-centric organization that’s focused on helping clients reduce the burden of disease on patients.”
The Pithampur site employs approximately 600 workers and supplies drug product to biotech, small pharma, large pharma and large generics customers around the world, supporting their needs for both on-patent and generic drug projects.
The site has been successfully inspected by a host of regulatory agencies including the FDA (US), MHRA (UK), MPA (Sweden), TGA (Australia), FIMEA (Finland) and ANVISA (Brazil).