Suppliers / Piramal Pharma Solutions

Piramal Pharma Solutions

India Updated 9 July 2026

The public registers hold a second record for Piramal Pharma Solutions. 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 Pharma Solutions is a finished-dose manufacturer based in India. It appears in 1 regulatory filing across 1 regulator, without an active US DMF or CEP on file. Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 10 December 2025 as VAI.

0
active US DMFs
0
valid CEPs
2
registered plants 1 with an FDA FEI number
1
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
8 of 8 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 10 December 2025 VAI US FDA
  • 10 January 2023 VAI US FDA
  • 11 April 2019 NAI US FDA
  • 14 March 2018 VAI US FDA
  • 17 April 2014 VAI US FDA
  • 15 April 2014 NAI US FDA
  • 27 February 2009 VAI US FDA
  • 13 February 2009 NAI US FDA

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

Registered plants

Site FDA FEI
Leiden, Netherlands Not on file
Lexington, United States 3006419237

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 1 None
EMA None 1
US FDA None 1

Questions about Piramal Pharma Solutions

Does Piramal Pharma Solutions hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Piramal Pharma Solutions. It does have 1 filing with one regulator, so it is registered, just not with the two strong registers buyers usually screen on.
Is Piramal Pharma Solutions FDA-registered?
One site operated by Piramal Pharma Solutions 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 Pharma Solutions's last inspection go?
The most recent inspection on record closed on 10 December 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Piramal Pharma Solutions manufacture?
2 registered sites are on record, in Netherlands and United States (Leiden and Lexington). Every site is listed on this page with the register it came from.
Which regulators recognise Piramal Pharma Solutions's GMP?
Current GMP certificates are on record from EMA 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 10 December 2025.

Comparable suppliers

Abbott Healthcare also in India Accent Pharmaceuticals Diagnostics also in India Accure Labs Pvt.Ltd also in India ACME Formulation also in India Acme Generics also in India

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