Suppliers / Unichem Laboratories

Unichem Laboratories

India 3 duplicate records merged Updated 9 July 2026

Unichem Laboratories is an API and finished-dose manufacturer based in India. It holds 29 valid CEPs across a filed portfolio of 29 molecules. Its filings concentrate with TMDA (TZ), MCAZ (ZW) and ZAMRA (ZM). Its GMP standing is certified by EMA, MHRA (UK) and US FDA, among 6 authorities. Its most recent recorded inspection, by US FDA, closed on 2 February 2026 as VAI. Customs aggregates show $188.4M of exports covering 4,657 molecules to 68 destinations in 2025.

0
active US DMFs
29
valid CEPs
10
registered plants 5 with an FDA FEI number
140
filings across 13 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
5 of 5 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

  • 2 February 2026 VAI US FDA
  • 20 June 2025 VAI US FDA
  • 28 February 2025 VAI US FDA
  • 15 July 2024 VAI US FDA
  • 13 February 2024 NAI US FDA
  • 21 February 2020 NAI US FDA
  • 12 January 2020 VAI US FDA
  • 20 September 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
Mumbai, India Not on file
GOA, India Not on file
HIMACHAL PRADESH, India Not on file
Ghaziabad, India 3004082076
Bardez, India 3005497507
Raigad, India 3004373180

4 further sites are on record.

What they file, and where

Molecule Regulators Docs
Hydrochlorothiazide EDQM, SFDA (Saudi Arabia) 3
Alfuzosin EDQM, SFDA (Saudi Arabia) 2
Bisoprolol EDQM, SFDA (Saudi Arabia) 2
Donepezil EDQM, SFDA (Saudi Arabia) 2
Irbesartan EDQM, SFDA (Saudi Arabia) 2
Teriflunomide EDQM, SFDA (Saudi Arabia) 2
Zolpidem EDQM, SFDA (Saudi Arabia) 2
Amlodipine EDQM 1
Amlodipine Besilate EDQM 1
Aripiprazole EDQM 1
Show all 29 molecules on file
Bendroflumethiazide EDQM 1
Bumetanide EDQM 1
Buprenorphine EDQM 1
Buspirone EDQM 1
Clonidine EDQM 1
Lamotrigine EDQM 1
Meloxicam EDQM 1
Memantine SFDA (Saudi Arabia) 1
Metronidazole EDQM 1
Nateglinide EDQM 1
Phenylephrine EDQM 1
Piroxicam EDQM 1
Pramipexole Dihydrochloride EDQM 1
Quetiapine EDQM 1
Rizatriptan EDQM 1
Solifenacin Succinate EDQM 1
Tadalafil EDQM 1
Tamsulosin EDQM 1
Tizanidine EDQM 1

Also appears on these molecule pages

Alfuzosin API Amlodipine API Ampicillin finished dose Aripiprazole API Baclofen finished dose Bisoprolol API Bumetanide API Buprenorphine API Buspirone API Chlorthalidone finished dose Clonidine API Donepezil API
Show 22 more molecule pages
Hydrochlorothiazide API Irbesartan API Lamotrigine API Losartan finished dose Meloxicam API Memantine API Metronidazole API Nateglinide API Phenylephrine API Piroxicam API Pramipexole API Quetiapine API Rizatriptan API Solifenacin API Sulbactam finished dose Tadalafil API Tamsulosin API Teriflunomide API Tizanidine API Tolterodine finished dose Tramadol finished dose Zolpidem API

Filings and GMP by regulator

Regulator Filings GMP certificates
TMDA (TZ) 38 None
MCAZ (ZW) 38 None
ZAMRA (ZM) 18 None
NAFDAC (NG) 16 1
DAV (Vietnam) 12 None
BOMRA (BW) 5 None
EMA None 8
MHRA (UK) None 5
US FDA None 5
ANVISA (Brazil) None 5
FDA (GH) None 3

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $25.5M 48
2025 $242.3M $188.4M 68
2024 $213.3M $201.1M 67
2023 $162.6M $161.7M 69

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 Unichem Laboratories

Does Unichem Laboratories hold a US DMF or a CEP?
Unichem Laboratories holds 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 Unichem Laboratories FDA-registered?
5 sites operated by Unichem Laboratories 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 Unichem Laboratories's last inspection go?
The most recent inspection on record closed on 2 February 2026 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Unichem Laboratories manufacture?
10 registered sites are on record, in India (Mumbai, GOA and Himachal Pradesh among others). Every site is listed on this page with the register it came from.
What does Unichem Laboratories make?
29 molecules are on record against Unichem Laboratories, including Hydrochlorothiazide, Alfuzosin, Bisoprolol and Donepezil. Each links through to that molecule's full manufacturer list.
Which regulators recognise Unichem Laboratories's GMP?
Current GMP certificates are on record from EMA, MHRA (UK), US FDA, ANVISA (Brazil), FDA (GH) and 1 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. Unichem Laboratories 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 2 February 2026.

Comparable suppliers

Apitoria Pharma shares 16 molecules Zydus Lifesciences shares 15 molecules Dr Reddy's Laboratories shares 12 molecules Alembic Pharmaceuticals shares 12 molecules Hetero shares 10 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
Company filings
Revenue as reported