Suppliers / Optimus Drugs

Optimus Drugs

India Updated 9 July 2026

Optimus Drugs is an API manufacturer based in India. It holds 44 active US drug master files. Its GMP standing is certified by US FDA. 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.

44
active US DMFs
0
valid CEPs
2
registered plants 2 with an FDA FEI number
6
filings across 1 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 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
Yadadri-Bhuvanagiri (D), India 3014675555
Yadadri-Bhuvanagiri (D), India 3010419177

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 30 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

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
CDSCO (India) 6 None
US FDA None 1

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 We do not publish the identity of any buyer.

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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