Piramal Pharma Limited’s Pharma Solutions business, a leading contract development and manufacturing organisation (CDMO), has announced that the company’s site in Digwal in the state of Telangana, India, has implemented various tools to unlock active pharmaceutical ingredient (API) manufacturing capacity and support client needs in drug development and on-patent projects.
Since 2019, Piramal Pharma Solutions (PPS) has made or committed more than $30 million in capital investments, both in the infrastructure and the operational culture at the Digwal site, to improve performance, gain efficiencies, and increase capacity to meet market demands.
A driving force of this program is the company’s emphasis on Operational Excellence (OE) as part of the global corporate culture. By applying specific OE tools such as Theory of Constraint, Value Stream Mapping, Optimisation of Unit Operations and Line Balancing, more than 20% of the site’s capacity has been released to date.
Additional capacity will be released in the coming months as the OE tools generate further benefits. These initiatives will further help PPS cater to the immediate requirements of global customers. Further, to reduce manual interventions, mechanisation advancements are under way including investments in Powder Transfer Systems. On the documentation side, the site is moving away from paper records to Electronic Batch Records (eBMR).
Previously, Digwal embarked on a journey to extend its offerings to include development services for late-phase clinical requirements, clients pursuing registration and site transfers to support the commercial launch. The site enhanced its facilities, talent and processes to support phase-appropriate customer requirements.
Now, Digwal’s R&D capabilities are being further strengthened, with approximately 20 new fume hoods coming online to support services projects. As a result, the site has recently partnered with clients on more than a dozen programmes, including several that have been commercially launched and others that are under registration with the regulator.
As part of PPS’s strategy to provide simplicity and speed to customers through integrated projects which involve two or more sites, integrated project management processes and tools were developed. These initiatives have resulted in a more than 7-fold increase in order book from integrated projects for Digwal during the last 3 fiscal years.
As part of the company’s sustainability efforts, the Digwal site is equipped with a "Zero Liquid Discharge" facility to ensure all liquid waste gets adequately treated in-house and recycled back to utilities. The solvent recovery infrastructure has also been upgraded, resulting in increased distillation efficiency and a reduction in solvent consumption.
In addition, close monitoring and improved governance have helped in reducing the overall freshwater consumption. PPS is also investigating opportunities to deploy green chemistries for some large volume products.
Based on the company’s continued focus on Environmental, Health & Safety (EHS), the site was able to secure Environmental Clearance (EC) for the multi-fold expansion by the concerned authorities, covering the site for the growth envisaged in the next 7-10 years.
In addition to the increased reactor capacity, the Digwal site will benefit from infrastructure upgrades that include a renovated administration block, a new canteen facility, Quality Control lab revamp and more. The consolidation and creation of a centralised new warehouse for the storage of finished goods that features a warehouse management system (WMS) are currently under way.
Peter DeYoung, Chief Executive Officer, Piramal Pharma Solutions, said: “We are now seeing the fruits of our labour in applying Operational Excellence practices at Digwal. Coupled with the capital investment we are making, our API capabilities at the site are moving to the next level."
"Digwal can now take on more complex and larger-scale projects than it could in the past. It’s another example of how we continue to invest and grow to serve market demands and work with our clients to reduce the burden of disease on patients.”
The Digwal site covers more than 100 acres and employs approximately 825 FTEs. In addition to producing APIs, Digwal provides analytical services and offers anaesthetic drug product (bottling) services. The site has undergone more than twenty successful inspections by a host of regulatory agencies including FDA (US), MHRA (UK), PMDA (Japan) and ANVISA (Brazil) and has been successfully audited by numerous global customers.
