Suppliers / Optimus Drugs

Optimus Drugs

India reconciled across 22 public records · 4 entities Updated 9 July 2026

Optimus Drugs is an API manufacturer based in India. It holds 53 active US drug master files. Its filings concentrate with CDSCO (India), US FDA and EEC_EAEU. Its GMP standing is certified by US FDA, EMA and EAEU_EEC. Its most recent recorded inspection, by US FDA, closed on 19 December 2025 as VAI. Customs aggregates show $34.9M of exports covering 573 molecules to 39 destinations in 2025.

53
active US DMFs
0
valid CEPs
4
registered plants 3 with an FDA FEI number
41
filings across 4 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
3 of 3 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 19 December 2025 VAI US FDA
  • 23 June 2023 VAI US FDA
  • 6 September 2019 NAI US FDA
  • 23 May 2019 NAI US FDA
  • 18 March 2016 VAI US FDA

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

Registered plants

Site FDA FEI
Sangareddy, India 3013914542
Yadadri-Bhuvanagiri (D), India 3010419177
Yadadri-Bhuvanagiri (D), India 3014675555
Isnapur, India Not on file

What they file, and where

Molecule Regulators Docs
Linezolid SFDA (Saudi Arabia), US FDA 6
Pregabalin SFDA (Saudi Arabia), US FDA 3
Midodrine SFDA (Saudi Arabia), US FDA 2
Solifenacin Succinate SFDA (Saudi Arabia), US FDA 2
Aminocaproic Acid US FDA 1
Apixaban US FDA 1
Bempedoic Acid US FDA 1
Brivaracetam US FDA 1
Bucillamine US FDA 1
Cariprazine US FDA 1
Show all 40 molecules on file
Cenobamate US FDA 1
Crisaborole US FDA 1
Dabigatran Etexilate US FDA 1
Dapagliflozin US FDA 1
Dapoxetine SFDA (Saudi Arabia) 1
Dexlansoprazole US FDA 1
Dimethyl Fumarate US FDA 1
Edoxaban US FDA 1
Elagolix US FDA 1
Eltrombopag US FDA 1
Empagliflozin US FDA 1
Favipiravir US FDA 1
Finerenone US FDA 1
Isavuconazonium US FDA 1
Linagliptin US FDA 1
Lornoxicam SFDA (Saudi Arabia) 1
Mebendazole US FDA 1
Mesalazine US FDA 1
Molnupiravir US FDA 1
Nirmatrelvir US FDA 1
Obeticholic Acid US FDA 1
Penicillamine US FDA 1
Pirfenidone US FDA 1
Rifaximin US FDA 1
Rivaroxaban US FDA 1
Safinamide US FDA 1
Sitagliptin US FDA 1
Tafamidis US FDA 1
Tapinarof US FDA 1
Teriflunomide US FDA 1

Also appears on these molecule pages

Show 27 more molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
CDSCO (India) 35 None
US FDA 3 2
EEC_EAEU 2 None
UZPHARM (UZ) 1 None
EMA None 2
EAEU_EEC None 2

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $8.4M 24
2025 Not reported $34.9M 39
2024 Not reported $35.9M 38
2023 Not reported $21.4M 40

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

Questions about Optimus Drugs

Does Optimus Drugs hold a US DMF or a CEP?
Optimus Drugs holds 53 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 Optimus Drugs FDA-registered?
3 sites operated by Optimus Drugs 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 Optimus Drugs's last inspection go?
The most recent inspection on record closed on 19 December 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Optimus Drugs manufacture?
4 registered sites are on record, in India (Sangareddy, Yadadri-bhuvanagiri (d) and Isnapur among others). Every site is listed on this page with the register it came from.
What does Optimus Drugs make?
40 molecules are on record against Optimus Drugs, including Linezolid, Pregabalin, Midodrine and Solifenacin Succinate. Each links through to that molecule's full manufacturer list.
Which regulators recognise Optimus Drugs's GMP?
Current GMP certificates are on record from US FDA, EMA and EEC (Eurasian Economic Union). 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

  • 1 active litigation matter is on record.
  • The most recent inspection outcome was VAI, on 19 December 2025.

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