Suppliers / Onesource Specialty Pharma

Onesource Specialty Pharma

India Updated 9 July 2026

Onesource Specialty Pharma is a finished-dose manufacturer based in India. It appears in 17 regulatory filings across 3 regulators, without an active US DMF or CEP on file. Its filings concentrate with US FDA, ARCSA (EC) and JFDA (JO). Its GMP standing is certified by EMA, ANVISA (Brazil) and US FDA. Its most recent recorded inspection, by US FDA, closed on 28 March 2025 as VAI. Customs aggregates show $313 of exports covering 11 molecules to 5 destinations in 2025.

0
active US DMFs
0
valid CEPs
5
registered plants 3 with an FDA FEI number
17
filings across 3 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
3 of 3 confirmed
Inspections
8 of 8 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

  • 28 March 2025 VAI US FDA
  • 28 March 2024 VAI US FDA
  • 20 December 2019 VAI US FDA
  • 14 February 2019 VAI US FDA
  • 13 March 2018 VAI US FDA
  • 16 March 2016 VAI US FDA
  • 1 September 2015 OAI US FDA
  • 8 August 2014 OAI US FDA

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

Registered plants

Site FDA FEI
Bengaluru, India 3005652193
Bengaluru Rural, India 3017501030
Bengaluru, India 3003813519
BANGALORE, India Not on file
Bommasandra, India Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 10 2
ARCSA (EC) 5 None
JFDA (JO) 2 None
EMA None 7
ANVISA (Brazil) None 6

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $3.9M 13
2025 Not reported $313 5
2024 Not reported $10 1

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 We do not publish the identity of any buyer.

Questions about Onesource Specialty Pharma

Does Onesource Specialty Pharma hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Onesource Specialty Pharma. It does have 17 filings with 3 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Onesource Specialty Pharma FDA-registered?
3 sites operated by Onesource Specialty Pharma carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Onesource Specialty Pharma's last inspection go?
The most recent inspection on record closed on 28 March 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file, of which 2 closed as OAI.
Where does Onesource Specialty Pharma manufacture?
5 registered sites are on record, in India (Bengaluru, Bengaluru Rural and Bangalore among others). Every site is listed on this page with the register it came from.
Which regulators recognise Onesource Specialty Pharma's GMP?
Current GMP certificates are on record from EMA, ANVISA (Brazil) 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 28 March 2025.

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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
Customs aggregates
Export values, molecule and destination counts