Suppliers / Piramal Pharma

Piramal Pharma

India PPLPHARMA.BO reconciled across 24 public records · 10 entities Updated 9 July 2026

Piramal Pharma is an API and finished-dose manufacturer based in India. It holds 62 active US drug master files and 29 valid CEPs. Its filings concentrate with EMA, AIFA (IT) and US FDA. Its GMP standing is certified by MHRA (UK), EMA and US FDA, among 10 authorities. Its most recent recorded inspection, by US FDA, closed on 10 December 2025 as VAI. Customs aggregates show $385.3M of exports covering 2,966 molecules to 100 destinations in 2025.

62
active US DMFs
29
valid CEPs
26
registered plants 9 with an FDA FEI number
385
filings across 33 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
4 of 4 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
  • 30 May 2025 NAI US FDA
  • 17 February 2025 VAI US FDA
  • 27 September 2023 VAI US FDA
  • 19 May 2023 NAI US FDA
  • 31 March 2023 NAI US FDA
  • 10 January 2023 VAI US FDA
  • 18 March 2022 VAI US FDA
  • 18 June 2021 VAI US FDA
  • 30 August 2019 NAI US FDA
  • 7 May 2019 NAI US FDA
  • 11 April 2019 NAI 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
Morpeth, United Arab Emirates Not on file
Canada, Canada 3002808377
Rüschlikon, Switzerland Not on file
WEST DRAYTON, United Kingdom Not on file
Morpeth, United Kingdom Not on file

20 further sites are on record.

What they file, and where

Molecule Regulators Docs
Verapamil EDQM, SFDA (Saudi Arabia), US FDA 4
Baclofen EDQM, SFDA (Saudi Arabia), US FDA 3
Diltiazem EDQM, US FDA 3
Amiodarone EDQM, US FDA 2
Aprepitant EDQM, US FDA 2
Bisoprolol EDQM, US FDA 2
Brimonidine EDQM, US FDA 2
Cinacalcet SFDA (Saudi Arabia), US FDA 2
Desmopressin EDQM, US FDA 2
Entacapone EDQM, US FDA 2
Show all 40 molecules on file
Isoflurane SFDA (Saudi Arabia), US FDA 2
Ketoconazole EDQM, US FDA 2
Leuprolide EDQM, US FDA 2
Mebeverine EDQM, SFDA (Saudi Arabia) 2
Mirabegron EDQM, US FDA 2
Misoprostol EDQM, US FDA 2
Oxytocin EDQM, US FDA 2
Terlipressin EDQM, SFDA (Saudi Arabia) 2
Trazodone EDQM, US FDA 2
Abacavir SFDA (Saudi Arabia) 1
Acyclovir US FDA 1
Anagrelide US FDA 1
Armodafinil US FDA 1
Azilsartan Medoxomil US FDA 1
Bexagliflozin US FDA 1
Buserelin EDQM 1
Calcitonin (Salmon) EDQM 1
Cetrorelix US FDA 1
Clobazam US FDA 1
Cloprostenol US FDA 1
Dabigatran Etexilate US FDA 1
Dabigatran Etexilate Mesilate EDQM 1
Dapagliflozin US FDA 1
Dapagliflozin Propanediol SFDA (Saudi Arabia) 1
Deferasirox US FDA 1
Desflurane US FDA 1
Dexlansoprazole US FDA 1
Donepezil US FDA 1
Dronedarone US FDA 1
Droxidopa US FDA 1

Also appears on these molecule pages

Show 51 more molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA 70 8
AIFA (IT) 39 None
US FDA 37 6
FAMHP (BE) 22 None
MPA (SE) 19 None
DIGEMAPS (DO) 19 None
MHRA (UK) None 20
ZLG (DE) None 6
MFDS (Korea) None 2
NAFDAC (NG) None 2
ANVISA (Brazil) None 2
NSW_HEALTH None 2
NCELS (KZ) None 1
TMDA (TZ) None 1

Scale

Year Revenue Exports Destinations
2026 YTD $1.0B $395.6M 52
2025 $1.1B $385.3M 100
2024 $976.5M $373.2M 91
2023 Not reported $215.7M 100

Export figures are customs aggregates. We do not publish the identity of any buyer. Revenue shown in US dollars, converted from the reported currency.

Questions about Piramal Pharma

Does Piramal Pharma hold a US DMF or a CEP?
Piramal Pharma holds 62 active US drug master files and 29 valid CEPs. 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 Pharma FDA-registered?
9 sites operated by Piramal Pharma carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Piramal Pharma'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). 24 inspections are on file.
Where does Piramal Pharma manufacture?
26 registered sites are on record, in United Arab Emirates, Canada, Switzerland and United Kingdom (Bethlehem, Morpeth and Canada among others). Every site is listed on this page with the register it came from.
What does Piramal Pharma make?
40 molecules are on record against Piramal Pharma, including Verapamil, Baclofen, Diltiazem and Amiodarone. Each links through to that molecule's full manufacturer list.
Which regulators recognise Piramal Pharma's GMP?
Current GMP certificates are on record from MHRA (UK), EMA, US FDA, ZLG (DE), MFDS (Korea) and 5 more. 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.

Comparing suppliers?

Choose your molecules and target markets. Piramal Pharma comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Open risk flags

  • 8 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 10 December 2025.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates
Customs aggregates
Export values, molecule and destination counts
Company filings
Revenue as reported