Suppliers / Piramal Critical Care

Piramal Critical Care

United States 338 employees Updated 9 July 2026

The public registers hold a second record for Piramal Critical Care. The fuller profile, with 62 active US DMFs and 29 valid CEPs, is at Piramal Pharma. Figures on this page cover only this record.

Piramal Critical Care is an API and 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

Baclofen finished dose Dimethyl finished dose Etomidate finished dose Fentanyl finished dose Icatibant finished dose Isoflurane API Levothyroxine finished dose Linezolid finished dose Miglustat finished dose Morphine finished dose Pantoprazole finished dose Sevoflurane API
Show 3 more molecule pages
Sugammadex finished dose Sunitinib finished dose Tigecycline finished dose

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

Questions about Piramal Critical Care

Does Piramal Critical Care hold a US DMF or a CEP?
Piramal Critical Care holds 1 active US drug master file. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Piramal Critical Care FDA-registered?
One site operated by Piramal Critical Care carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Piramal Critical Care's last inspection go?
The most recent inspection on record closed on 27 September 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 7 inspections are on file.
Where does Piramal Critical Care manufacture?
4 registered sites are on record, in United Arab Emirates, Switzerland, United Kingdom and United States (Bethlehem, Rüschlikon and West Drayton among others). Every site is listed on this page with the register it came from.
What does Piramal Critical Care make?
3 molecules are on record against Piramal Critical Care, including Desflurane, Isoflurane and Sevoflurane. Each links through to that molecule's full manufacturer list.
Which regulators recognise Piramal Critical Care's GMP?
Current GMP certificates are on record from MHRA (UK), MFDS (Korea) and US FDA. GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Open risk flags

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

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Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

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