Suppliers / IOL Chemicals and Pharmaceuticals

IOL Chemicals and Pharmaceuticals

India Updated 9 July 2026

IOL Chemicals and Pharmaceuticals is an API manufacturer based in India. It holds 16 active US drug master files and 21 valid CEPs across a filed portfolio of 18 molecules. Its GMP standing is certified by EMA and MFDS (Korea). Its most recent recorded inspection, by US FDA, closed on 9 August 2019 as VAI. Customs aggregates show $48.3M of exports covering 1,065 molecules to 83 destinations in 2025.

16
active US DMFs
21
valid CEPs
4
registered plants 1 with an FDA FEI number
7
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
2 of 2 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

  • 9 August 2019 VAI US FDA
  • 17 April 2015 VAI US FDA

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

Registered plants

Site FDA FEI
Ludhiana, India Not on file
Ludhiana, India Not on file
Barnala, India 3008232281
Barnala, India Not on file

What they file, and where

Molecule Regulators Docs
Ibuprofen EDQM, SFDA (Saudi Arabia), US FDA 6
Clopidogrel EDQM, US FDA 3
Lamotrigine EDQM, US FDA 3
Metformin EDQM, US FDA 3
Pantoprazole EDQM, US FDA 3
Acetaminophen EDQM, US FDA 2
Allopurinol EDQM, US FDA 2
Fenofibrate EDQM, US FDA 2
Levetiracetam EDQM, US FDA 2
Losartan EDQM, US FDA 2
Show all 18 molecules on file
Mesalazine EDQM, US FDA 2
Quetiapine EDQM, US FDA 2
Sitagliptin EDQM, US FDA 2
Valsartan EDQM, US FDA 2
Gabapentin EDQM 1
Metformin Hydrochloride EDQM 1
Minoxidil EDQM 1
Pantoprazole Sodium Sesquihydrate EDQM 1

Also appears on these molecule pages

Acetaminophen API Allopurinol API Clopidogrel API Fenofibrate API Gabapentin API Ibuprofen API Lamotrigine API Levetiracetam API Losartan API Mesalamine API Mesalazine API Metformin API
Show 6 more molecule pages
Minoxidil API Pantoprazole API Paracetamol API Quetiapine API Sitagliptin API Valsartan API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 7 None
EMA None 3
MFDS (Korea) None 2

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $10.7M 50
2025 Not reported $48.3M 83
2024 Not reported $52.7M 84
2023 Not reported $66.6M 76

Export figures are customs aggregates. We do not publish the identity of any buyer.

Questions about IOL Chemicals and Pharmaceuticals

Does IOL Chemicals and Pharmaceuticals hold a US DMF or a CEP?
IOL Chemicals and Pharmaceuticals holds 16 active US drug master files and 21 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 IOL Chemicals and Pharmaceuticals FDA-registered?
One site operated by IOL Chemicals and Pharmaceuticals 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 IOL Chemicals and Pharmaceuticals's last inspection go?
The most recent inspection on record closed on 9 August 2019 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 2 inspections are on file.
Where does IOL Chemicals and Pharmaceuticals manufacture?
4 registered sites are on record, in India (Ludhiana and Barnala among others). Every site is listed on this page with the register it came from.
What does IOL Chemicals and Pharmaceuticals make?
18 molecules are on record against IOL Chemicals and Pharmaceuticals, including Ibuprofen, Clopidogrel, Lamotrigine and Metformin. Each links through to that molecule's full manufacturer list.
Which regulators recognise IOL Chemicals and Pharmaceuticals's GMP?
Current GMP certificates are on record from EMA and MFDS (Korea). 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. IOL Chemicals and Pharmaceuticals comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Open risk flags

  • The most recent inspection outcome was VAI, on 9 August 2019.

Comparable suppliers

Ipca Laboratories shares 10 molecules Apitoria Pharma shares 9 molecules Hetero shares 9 molecules Dr Reddy's Laboratories shares 8 molecules Zydus Lifesciences shares 7 molecules

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
Customs aggregates
Export values, molecule and destination counts