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Piramal Pharma Solutions — Aurora

Aurora, Canada · CDMO

This is a record of what regulators published, not a rating.

Site facts

Company
Piramal Pharma Solutions
Name(s) in FDA data
Piramal Healthcare (Canada) Ltd.
FEI number(s)
3002808377 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Aurora, Canada
Records matched
5 FDA inspections
Most recent FDA inspection in dataset
30 May 2025 — NAI

Capabilities (from the company's website)

  • API / drug substance (chemical)
    …ernational Airport Driving Distance: 37 miles (40 min) Development & GMP Manufacturing of APIs for complex NCEs Piramal's Aurora site specializes in route selection, process developmen…
  • Highly potent (HPAPI)
    …w grams to 100s’ kg scale. We have reactor suites capable of handling both non-potent and highly potent APIs. With an excellent quality track record, the Aurora facility is fully-equipped to su…
  • Spray drying & particle engineering
    …ent available, with 2 SS Quadro Comill, 1 SS Fitzmill, 1 Wet mill and 1 SS Jet Pulverizer micronizer. Analytical Development Services and Stability Studies expand_more Analytical Developme…
  • Analytical testing
    …, and manufacturing of APIs. The site is primarily comprised of Research and Development, Analytical Development, Analytical Services, Quality Control labs and three manufacturing areas. We have a long-…
  • Formulation & process development
    …ufacturing of APIs for complex NCEs Piramal's Aurora site specializes in route selection, process development, and manufacturing of APIs. The site is primarily comprised of Research and Development,…

Taken from the company's web page for this site. Source: https://www.piramalpharmasolutions.com/facilities/gmp-api-development-and-manufacturing-aurora, checked 16 Oct 2026. Quoted text shows the wording each tag is based on.

Regulatory timeline

Newest first. Each entry links to the published source. Inspection classifications: NAI = no action indicated, VAI = voluntary action indicated, OAI = official action indicated (FDA definitions). Posted 483 citations are FDA's short summaries, not the full Form 483.

  1. 30 May 2025
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Drugs, Veterinary. Project area(s): Drug Quality Assurance; Monitoring of Marketed Animal Drugs, Feed, and Devices.

    Source: FDA Data Dashboard – Inspections (FEI 3002808377, inspection ID 1275272)

  2. 18 May 2018
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3002808377, inspection ID 1055172)

  3. 27 Jun 2014
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3002808377, inspection ID 887844)

  4. 15 Jul 2011
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3002808377, inspection ID 737264)

  5. 17 Oct 2008
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3002808377, inspection ID 546753)

This is a record of what regulators published, not a rating. Absence of a record here does not mean no record exists; see methodology for what we check and how records are matched.