COVID-19

Dear Partners,

Necessitated by the unprecedented situation created by Covid-19, several industry events and tradeshows across the world have been postponed or stand cancelled. While we were looking forward to meet you, we at Piramal Pharma Solutions have had to take several precautionary measures to protect both our employees and customers, worldwide.

As we move forward in these extraordinary times, we want to assure you that that we are operational by taking the right safety measures and abundant precautions to ensure that we continue to support you and your patients.

While all of us are working remotely for now, you can schedule a discussion with us and we would be glad to help ensure you meet your pharmaceutical development and supply needs and thereby, your clinical and commercial timelines.

Please feel free to reach out to us at:
Stuart.Needleman@piramal.com

Our best wishes to colleagues, friends and family.

Best Regards,
Piramal Pharma Solutions

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Aurora

The Aurora site specializes in process/route selection, process development, cGMP, and non-GMP manufacturing of APIs. The site is primarily comprised of Research and Development, Analytical Development, Analytical Services, Quality Control labs and three manufacturing areas with a total of 18 plant scale reactors ranging from 200 – 4000L. The site is supported by over 200 qualified and dedicated employees operating on a 24/7 basis.

We have a long-standing regulatory history with US FDA, Health Canada, and PMDA Japan and are fully compliant with all applicable regulations, safety, and environmental standards.  The site is conveniently located 1 hour from the Toronto International Airport.

Location Address:

Piramal Healthcare Canada Ltd., 110 Industrial Parkway North, Aurora, Ontario L4G 3H4, Canada

Contact: +1905727-9417

Specialized Manufacturing Capabilities

  • Potent APIs manufacturing (OEL > 1µg/m 3 )
  • Non-GMP R&D scale-up suites, 50 – 100 L glass and glass-lined reactors
  • GMP manufacturing spanning 100s’ grams to 100s’ kg scale
  • GMP Kilo-lab suites, 50 – 100 L glass and glass-lined reactors
  • 18 plant scale reactors (stainless steel and glass-lined) ranging between 200 – 4000 L
  • Hydrogenation suite – 2 glass-lined reactors (200 L/9 bar and 800 L/5.8 bar)
  • Hastelloy horizontal basket centrifuges
  • Hastelloy filter-dryers
  • Range of milling capabilities including wet milling
  • Biotage Flash 400 chromatography kg scale

Featured Services

  • Process/route selection
  • API and impurity characterization and qualification program
  • Process optimization and development from early clinical phase through GMP scale-up, validation, commercialization, and launch
  • Analytical method development, validation, and QC services accomplished through state-of-the-art laboratory equipment
  • On site stability chambers to support stability studies
  • CMC filing support

Salient Features

  • State of the art lab services, production plants, and kilo-lab suites
  • US FDA, Health Canada and PMDA Japan inspected,  no critical observations/483s in the past 10 years
  • 24/7 operation

Click here: Visitor Guide

Click here: Aurora Sell Sheet

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