North American API Development & Manufacturing

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With recently expanded API sites in Riverview, Michigan, and Aurora, Ontario, Piramal Pharma Solutions is equipped to produce your most challenging APIs onshore in North America. These world-class sites are backed by a legacy of successful deliveries and positive regulatory inspections. Our expert team can provide early-phase to commercial-scale drug substance, eliminating the need for costly and time-consuming tech transfers.

Riverview, Michigan

6 Reasons to Partner with Riverview
Reverview Michigan Site
Our legacy
Over 60 years of successful, reliable API manufacturing with an exceptional regulatory record and 18 APIs launched to date.
State-of-the-art expansion
With enhanced capacity and newly added commercial-scale capabilities, Riverview is poised to empower your next innovation.
Our culture
The needs of our clients and their patients are second to none, enabling us to consistently deliver on our promise of quality and excellence.
Unmatched technical expertise
Our scientists have extensive experience across diverse therapeutic areas, enabling us to tackle even the most intricate challenges with confidence.
ADC support
As our dedicated supplier of payload-linkers, Riverview plays a vital role in ADCelerate™, our rapid and integrated approach to ADC development.
Commitment to Quality
Our Riverview facility is fully inspected by numerous regulatory agencies, including the US FDA, Health Canada, PMDA Japan, and COFEPRIS Mexico, among others. Alongside its impeccable regulatory record, the site boasts an exceptional number of FDA approvals, underscoring its uncompromising commitment to excellence.

Aurora, Ontario

6 Reasons to Partner with Aurora
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Our infrastructure
Aurora provides early phase to commercial scale, all in one site, all with one team.
Our people
We have a collaborative team of experts in every phase of API development and manufacturing, all dedicated to delivering quality materials for our clients.
Canadian Culture
Cooperative, collaborative, and communicative are just some of the inherent benefits our clients experience when working with us.
The PODs
This innovative, team-based platform ensures end-to-end execution of our development project portfolio with seamless collaboration and empowered accountability.
Capacity
There’s no waiting; we are ready to go. Sign on for a project and we will begin immediately.
Legacy of Quality
Our Aurora facility exemplifies our commitment to excellence, having successfully completed approximately 400 regulatory inspections from various agencies, including the US FDA, Health Canada, and PMDA Japan. The site recently achieved a flawless FDA inspection, marked by zero 483 observations and no NAI designations. We proudly maintain a record of over 1,900 successful client audits, reflecting our unwavering dedication to quality in every aspect of our work.

Facility Facts & Figures, Riverview:

  • Process research, early to late phase development, scale-up, non-GMP and cGMP clinical manufacturing, and cGMP commercial manufacturing
  • Recently completed USD $38M expansion featuring 10,000L of reactor capacity
  • Total GMP capacity of 25kL
  • Up to 4,000L glass-lined reaction vessels with a temperature range of -10°C to 200°C
  • Pilot plant with 4,000L capacity
  • Large-scale manufacturing from 25 to 4,000L
  • API from gram scale to 250kg batches
  • Hydrogenation facility with 200L capacity (up to 4 bar)
  • Kilo lab with 300L capacity and cryogenic temperatures up to -70°C
  • HPAPI manufacturing (OEL of 1 μg/m³ at kilo-lab scale; as low as 10ng/m³)
  • Solid state chemistry, crystallization, and analytical services on site
  • QbD services consistent with ICH guidelines
  • Extensive experience with FDA Fast-Track APIs
  • Global Regulatory Approvals from USFDA, Health Canada, PMDA, and Australia

Facility Facts & Figures, Aurora:

  • Process research, process validation, route scouting, early to late phase development, and scale-up
  • Non-GMP and cGMP clinical manufacturing and cGMP commercial manufacturing
  • Recently completed CAD $30M expansion featuring two new reactor suites, a filter dryer room, and wet milling technology
  • Total GMP capacity of 25kL
  • 3 GMP plants with 200-4,000L capacity
  • Hydrogenation facility with 200-800L capacity (up to 7-9 bar)
  • Pre-clinical (non-GMP) kilo labs with 10g to kilograms capacity
  • GMP Kilo labs with 50-100L capacity
  • HPAPI manufacturing (OEL ≥ 1μg/m³)
  • Analytical method development, validation, and stability studies
  • Global Regulatory Approvals from USFDA, Health Canada, and PMDA
  • 15 APIs launched to date
Commercial manufacturing and packaging of OSDs and LCOs

Both sites are supported by an internal supply of Key Starting Materials (KSMs) from our sites in India.

Let’s Get Started!

Ready to learn more about how we can help your program reach its next milestone? Contact us and speak with a Piramal Pharma Solutions business development professional or technical expert to discover how we can help you thrive. With capacity currently available at our North American API facilities, now is the perfect time to partner with us!

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