Suppliers / Oxalis Labs

Oxalis Labs

India 2 duplicate records merged Updated 9 July 2026

Oxalis Labs is a finished-dose manufacturer based in India. It appears in 6 regulatory filings across 2 regulators, without an active US DMF or CEP on file. Its filings concentrate with CDSCO (India) and NAFDAC (NG). Its GMP standing is certified by US FDA, NCELS (KZ) and FDA (GH), among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 2 June 2023 as VAI.

0
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
6
filings across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
2 of 2 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 2 June 2023 VAI US FDA
  • 2 August 2019 VAI US FDA

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

Registered plants

Site FDA FEI
Solan, India 3010868532

Filings and GMP by regulator

Regulator Filings GMP certificates
CDSCO (India) 3 None
NAFDAC (NG) 3 1
US FDA None 1
NCELS (KZ) None 1
FDA (GH) None 1

Questions about Oxalis Labs

Does Oxalis Labs hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Oxalis Labs. It does have 6 filings with 2 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Oxalis Labs FDA-registered?
One site operated by Oxalis Labs 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 Oxalis Labs's last inspection go?
The most recent inspection on record closed on 2 June 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 2 inspections are on file.
Where does Oxalis Labs manufacture?
1 registered site is on record, in India (Solan). Every site is listed on this page with the register it came from.
Which regulators recognise Oxalis Labs's GMP?
Current GMP certificates are on record from US FDA, NCELS (KZ), FDA (GH) and NAFDAC (NG). 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 2 June 2023.

Comparable suppliers

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Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates