Suppliers / Piramal Critical Care

Piramal Critical Care

United States 338 employees Updated 9 July 2026

Piramal Critical Care is a finished-dose manufacturer based in United States. It holds one active US drug master file across a filed portfolio of 3 molecules. Its filings concentrate with EMA, AIFA (IT) and FAMHP (BE). Its GMP standing is certified by MHRA (UK), MFDS (Korea) and US FDA. Its most recent recorded inspection, by US FDA, closed on 27 September 2023 as VAI.

1
active US DMFs
0
valid CEPs
4
registered plants 1 with an FDA FEI number
304
filings across 24 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
7 of 7 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 27 September 2023 VAI US FDA
  • 7 May 2019 NAI US FDA
  • 22 September 2017 VAI US FDA
  • 31 October 2014 VAI US FDA
  • 26 July 2013 VAI US FDA
  • 12 August 2011 VAI US FDA
  • 26 August 2010 VAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Bethlehem, United Arab Emirates Not on file
Rüschlikon, Switzerland Not on file
WEST DRAYTON, United Kingdom Not on file
Bethlehem, United States 1000135935

What they file, and where

Molecule Regulators Docs
Desflurane US FDA 1
Isoflurane SFDA (Saudi Arabia) 1
Sevoflurane SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA 70 None
AIFA (IT) 39 None
FAMHP (BE) 22 None
MPA (SE) 18 None
URPL (PL) 17 None
MHRA (UK) 15 4
MFDS (Korea) None 2
US FDA None 1

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Open risk flags

  • The most recent inspection outcome was VAI, on 27 September 2023.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates