Suppliers / Symed Labs

Symed Labs

India 403 employees Updated 9 July 2026

Symed Labs is an API manufacturer based in India. It holds 60 active US drug master files and 20 valid CEPs. Its filings concentrate with MINSA (CR) and CDSCO (India). Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 25 April 2025 as VAI. Customs aggregates show $18.8M of exports covering 495 molecules to 52 destinations in 2025.

60
active US DMFs
20
valid CEPs
5
registered plants 5 with an FDA FEI number
3
filings across 2 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

  • 25 April 2025 VAI US FDA
  • 6 December 2024 VAI US FDA
  • 2 February 2024 NAI US FDA
  • 28 July 2018 VAI US FDA
  • 11 May 2018 VAI US FDA
  • 4 May 2018 VAI US FDA
  • 8 December 2017 VAI US FDA
  • 6 November 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
Medchal-Malkajgiri, India 3005522065
Sangareddy, India 3007164063
Nalgonda, India 3012725393
Yadadri Bhuvangiri, India 3015443266
Hyderabad, India 3005739922

What they file, and where

Molecule Regulators Docs
Linezolid SFDA (Saudi Arabia), US FDA 9
Hydroxyzine EDQM, US FDA 5
Rivaroxaban EDQM, SFDA (Saudi Arabia), US FDA 5
Bilastine US FDA 4
Brimonidine EDQM, SFDA (Saudi Arabia), US FDA 4
Deferasirox EDQM, SFDA (Saudi Arabia), US FDA 4
Ezetimibe US FDA 4
Ketorolac EDQM, SFDA (Saudi Arabia), US FDA 4
Amisulpride EDQM, SFDA (Saudi Arabia) 3
Hydroxychloroquine EDQM, US FDA 3
Show all 30 molecules on file
Iron Sucrose SFDA (Saudi Arabia), US FDA 3
Levocetirizine Dihydrochloride EDQM, SFDA (Saudi Arabia) 3
Modafinil EDQM, US FDA 3
Prucalopride SFDA (Saudi Arabia), US FDA 3
Tizanidine EDQM, US FDA 3
Carbinoxamine US FDA 2
Dapoxetine SFDA (Saudi Arabia) 2
Dronedarone US FDA 2
Eszopiclone US FDA 2
Iloperidone US FDA 2
Lanthanum Carbonate US FDA 2
Levocetirizine US FDA 2
Meclizine US FDA 2
Meprobamate US FDA 2
Otilonium Bromide US FDA 2
Phentermine US FDA 2
Sertraline US FDA 2
Sucrose US FDA 2
Vortioxetine US FDA 2
Carvedilol EDQM 1

Also appears on these molecule pages

Amisulpride API Bilastine API Brimonidine API Carvedilol API Dapoxetine API Deferasirox API Dronedarone API Eszopiclone API Ezetimibe API Hydroxychloroquine API Hydroxyzine API Iloperidone API
Show 18 more molecule pages
Ketorolac Tromethamine API Lanthanum Carbonate API Levocetirizine API Linezolid API Meclizine API Meprobamate API Modafinil API Ondansetron API Otilonium API Phentermine API Pregabalin API Prucalopride API Racecadotril API Rivaroxaban API Sertraline API Tapentadol API Tizanidine API Vortioxetine API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 2 None
CDSCO (India) 1 None
EMA None 5
US FDA None 3

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $7.2M 41
2025 Not reported $18.8M 52

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

Questions about Symed Labs

Does Symed Labs hold a US DMF or a CEP?
Symed Labs holds 60 active US drug master files and 20 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 Symed Labs FDA-registered?
5 sites operated by Symed Labs 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 Symed Labs's last inspection go?
The most recent inspection on record closed on 25 April 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Symed Labs manufacture?
5 registered sites are on record, in India (Medchal-malkajgiri, Sangareddy and Nalgonda among others). Every site is listed on this page with the register it came from.
What does Symed Labs make?
30 molecules are on record against Symed Labs, including Linezolid, Hydroxyzine, Rivaroxaban and Bilastine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Symed Labs'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

  • 6 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 25 April 2025.

Comparable suppliers

Dr Reddy's Laboratories shares 12 molecules Apitoria Pharma shares 10 molecules Alivus Life Sciences shares 10 molecules Alembic Pharmaceuticals shares 10 molecules Matrix Pharmacorp shares 9 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