Suppliers / Rui Laboratories

Rui Laboratories

India 28 employees Updated 9 July 2026

Rui Laboratories is an API and finished-dose manufacturer based in India. It holds 3 active US drug master files and one valid CEP across a filed portfolio of 2 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 20 September 2024 as NAI. Customs aggregates show $14K of exports covering 2 molecules to 2 destinations in 2025.

3
active US DMFs
1
valid CEPs
2
registered plants 1 with an FDA FEI number
1
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 20 September 2024 NAI US FDA

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

Registered plants

Site FDA FEI
Anakapalli, India 3016661377
Visakhapatnam, India Not on file

What they file, and where

Molecule Regulators Docs
Levetiracetam EDQM, US FDA 2
Rosuvastatin US FDA 2

Also appears on these molecule pages

Levetiracetam API Molnupiravir finished dose Rosuvastatin API

Filings and GMP by regulator

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

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $26K 2
2025 Not reported $14K 2
2024 Not reported $726K 4
2023 Not reported $46K 3

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 We do not publish the identity of any buyer.

Questions about Rui Laboratories

Does Rui Laboratories hold a US DMF or a CEP?
Rui Laboratories holds 3 active US drug master files and 1 valid CEP. 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 Rui Laboratories FDA-registered?
One site operated by Rui Laboratories 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 Rui Laboratories's last inspection go?
The most recent inspection on record closed on 20 September 2024 as NAI (No Action Indicated: nothing objectionable was found). 1 inspection is on file.
Where does Rui Laboratories manufacture?
2 registered sites are on record, in India (Anakapalli and Visakhapatnam). Every site is listed on this page with the register it came from.
What does Rui Laboratories make?
2 molecules are on record against Rui Laboratories, including Levetiracetam and Rosuvastatin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Rui Laboratories's GMP?
Current GMP certificates are on record from 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 NAI, on 20 September 2024.

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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