Suppliers / Optimus Pharma

Optimus Pharma

India 401 employees Updated 9 July 2026

The public registers hold a second record for Optimus Pharma. The fuller profile, with 53 active US DMFs and 0 valid CEPs, is at Optimus Drugs. Figures on this page cover only this record.

Optimus Pharma is a finished-dose manufacturer based in India. It appears in 33 regulatory filings across 3 regulators, without an active US DMF or CEP on file. Its filings concentrate with CDSCO (India), US FDA and UZPHARM (UZ). Its GMP standing is certified by EAEU_EEC, EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 23 June 2023 as VAI. Customs aggregates show $1.2M of exports covering 31 molecules to 8 destinations in 2025.

0
active US DMFs
0
valid CEPs
2
registered plants 1 with an FDA FEI number
33
filings across 3 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 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

  • 23 June 2023 VAI US FDA
  • 6 September 2019 NAI 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
Isnapur, India Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
CDSCO (India) 29 None
US FDA 3 1
UZPHARM (UZ) 1 None
EAEU_EEC None 2
EMA None 2

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $46K 1
2025 Not reported $1.2M 8
2024 Not reported $2.1M 5
2023 Not reported $1.5M 5

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 We do not publish the identity of any buyer.

Questions about Optimus Pharma

Does Optimus Pharma hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Optimus Pharma. It does have 33 filings with 3 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Optimus Pharma FDA-registered?
One site operated by Optimus Pharma carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Optimus Pharma's last inspection go?
The most recent inspection on record closed on 23 June 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 2 inspections are on file.
Where does Optimus Pharma manufacture?
2 registered sites are on record, in India (Sangareddy and Isnapur). Every site is listed on this page with the register it came from.
Which regulators recognise Optimus Pharma's GMP?
Current GMP certificates are on record from EEC (Eurasian Economic Union), 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 23 June 2023.

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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