Suppliers / Symbiotec Pharmalab

Symbiotec Pharmalab

India Updated 9 July 2026

Symbiotec Pharmalab is an API manufacturer based in India. It holds 49 active US drug master files across a filed portfolio of 23 molecules. Its GMP standing is certified by MFDS (Korea) and EMA. Its most recent recorded inspection, by US FDA, closed on 30 September 2022 as VAI. Customs aggregates show $29.6M of exports covering 312 molecules to 39 destinations in 2025.

49
active US DMFs
0
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
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

  • 30 September 2022 VAI US FDA
  • 22 October 2019 VAI US FDA
  • 13 September 2019 VAI US FDA
  • 12 May 2017 VAI US FDA
  • 5 May 2017 VAI US FDA
  • 10 April 2015 NAI US FDA
  • 25 July 2014 NAI US FDA
  • 20 January 2012 NAI US FDA

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

Registered plants

Site FDA FEI
Indore, India 3005122933
Dhar, India 3009298759

What they file, and where

Molecule Regulators Docs
Methylprednisolone SFDA (Saudi Arabia), US FDA 8
Prednisolone SFDA (Saudi Arabia), US FDA 7
Betamethasone US FDA 6
Hydrocortisone SFDA (Saudi Arabia), US FDA 6
Testosterone US FDA 5
Mometasone Furoate SFDA (Saudi Arabia), US FDA 3
Clobetasol Propionate US FDA 2
Deflazacort SFDA (Saudi Arabia), US FDA 2
Dexamethasone US FDA 2
Flumethasone US FDA 2
Show all 23 molecules on file
Progesterone SFDA (Saudi Arabia), US FDA 2
Desogestrel US FDA 1
Desoximetasone US FDA 1
Drospirenone US FDA 1
Estradiol US FDA 1
Ethinylestradiol US FDA 1
Halobetasol Propionate US FDA 1
Hydroxyprogesterone US FDA 1
Levonorgestrel US FDA 1
Prasterone US FDA 1
Testosterone Undecanoate US FDA 1
Triamcinolone US FDA 1
Ulobetasol SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Show 7 more molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
MFDS (Korea) None 2
EMA None 2

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $2.8M 16
2025 Not reported $29.6M 39
2024 Not reported $15.0M 32
2023 Not reported $15.8M 43

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 We do not publish the identity of any buyer.

Questions about Symbiotec Pharmalab

Does Symbiotec Pharmalab hold a US DMF or a CEP?
Symbiotec Pharmalab holds 49 active US drug master files. 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 Symbiotec Pharmalab FDA-registered?
2 sites operated by Symbiotec Pharmalab 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 Symbiotec Pharmalab's last inspection go?
The most recent inspection on record closed on 30 September 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Symbiotec Pharmalab manufacture?
2 registered sites are on record, in India (Indore and Dhar). Every site is listed on this page with the register it came from.
What does Symbiotec Pharmalab make?
23 molecules are on record against Symbiotec Pharmalab, including Methylprednisolone, Prednisolone, Betamethasone and Hydrocortisone. Each links through to that molecule's full manufacturer list.
Which regulators recognise Symbiotec Pharmalab's GMP?
Current GMP certificates are on record from MFDS (Korea) and EMA. 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 30 September 2022.

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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