Suppliers / Nuray Chemicals

Nuray Chemicals

India 331 employees Updated 9 July 2026

Nuray Chemicals is an API manufacturer based in India. It holds 11 active US drug master files and 2 valid CEPs across a filed portfolio of 10 molecules. Its GMP standing is certified by MFDS (Korea) and US FDA. Its most recent recorded inspection, by US FDA, closed on 25 June 2024 as NAI. Customs aggregates show $12.3M of exports covering 323 molecules to 27 destinations in 2025.

11
active US DMFs
2
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
3 of 3 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 25 June 2024 NAI US FDA
  • 3 November 2017 NAI US FDA
  • 13 February 2015 VAI US FDA

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

Registered plants

Site FDA FEI
Tiruvallur, India 3006098295
Thiruvallur, India Not on file

What they file, and where

Molecule Regulators Docs
Pitolisant US FDA 3
Alosetron US FDA 2
Tetraferric Tricitrate Decahydrate US FDA 2
Acebutolol EDQM 1
Atovaquone US FDA 1
Benazepril US FDA 1
Carglumic Acid SFDA (Saudi Arabia) 1
Dapsone EDQM 1
Glycerol Phenylbutyrate US FDA 1
Tranylcypromine US FDA 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
CDSCO (India) 1 None
MFDS (Korea) None 2
US FDA None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $1.8M 11
2025 Not reported $12.3M 27
2024 Not reported $6.2M 32
2023 Not reported $6.7M 29

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 We do not publish the identity of any buyer.

Questions about Nuray Chemicals

Does Nuray Chemicals hold a US DMF or a CEP?
Nuray Chemicals holds 11 active US drug master files and 2 valid CEPs. 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 Nuray Chemicals FDA-registered?
One site operated by Nuray Chemicals 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 Nuray Chemicals's last inspection go?
The most recent inspection on record closed on 25 June 2024 as NAI (No Action Indicated: nothing objectionable was found). 3 inspections are on file.
Where does Nuray Chemicals manufacture?
2 registered sites are on record, in India (Tiruvallur and Thiruvallur). Every site is listed on this page with the register it came from.
What does Nuray Chemicals make?
10 molecules are on record against Nuray Chemicals, including Pitolisant, Alosetron, Tetraferric Tricitrate Decahydrate and Acebutolol. Each links through to that molecule's full manufacturer list.
Which regulators recognise Nuray Chemicals's GMP?
Current GMP certificates are on record from MFDS (Korea) 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 NAI, on 25 June 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