Suppliers / Smilax Laboratories

Smilax Laboratories

India 251 employees 2 duplicate records merged Updated 9 July 2026

Smilax Laboratories is an API manufacturer based in India. It holds 8 valid CEPs across a filed portfolio of 8 molecules. Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 15 September 2023 as VAI. Customs aggregates show $11.5M of exports covering 234 molecules to 33 destinations in 2025.

0
active US DMFs
8
valid CEPs
2
registered plants 2 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 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

  • 15 September 2023 VAI US FDA
  • 9 April 2015 NAI US FDA

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

Registered plants

Site FDA FEI
Hyderabad, India 3006251127
Visakhapatnam, India 3008772334

What they file, and where

Molecule Regulators Docs
Omeprazole EDQM, SFDA (Saudi Arabia) 2
Candesartan Cilexetil EDQM 1
Escitalopram EDQM 1
Esomeprazole EDQM 1
Guaifenesin EDQM 1
Pantoprazole EDQM 1
Sildenafil EDQM 1
Valsartan EDQM 1

Also appears on these molecule pages

Candesartan Cilexetil API Guaifenesin API Sildenafil API Valsartan API Omeprazole API Escitalopram API Esomeprazole API Pantoprazole API

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA None 1
US FDA None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $1.6M 22
2025 Not reported $11.5M 33
2024 Not reported $10.9M 34
2023 Not reported $22.4M 34

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 We do not publish the identity of any buyer.

Questions about Smilax Laboratories

Does Smilax Laboratories hold a US DMF or a CEP?
Smilax Laboratories holds 8 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 Smilax Laboratories FDA-registered?
2 sites operated by Smilax 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 Smilax Laboratories's last inspection go?
The most recent inspection on record closed on 15 September 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 2 inspections are on file.
Where does Smilax Laboratories manufacture?
2 registered sites are on record, in India (Hyderabad and Visakhapatnam). Every site is listed on this page with the register it came from.
What does Smilax Laboratories make?
8 molecules are on record against Smilax Laboratories, including Omeprazole, Candesartan Cilexetil, Escitalopram and Esomeprazole. Each links through to that molecule's full manufacturer list.
Which regulators recognise Smilax Laboratories'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 15 September 2023.

Comparable suppliers

Macleods Pharmaceuticals shares 2 molecules Torrent Pharmaceuticals shares 2 molecules Krka shares 2 molecules Apitoria Pharma shares 1 molecule Hetero shares 1 molecule

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