Suppliers / MSN Organics

MSN Organics

India Updated 9 July 2026

The public registers hold a second record for MSN Organics. The fuller profile, with 517 active US DMFs and 121 valid CEPs, is at MSN Laboratories. Figures on this page cover only this record.

MSN Organics is an API manufacturer based in India. It holds 32 active US drug master files and 11 valid CEPs across a filed portfolio of 26 molecules. Its most recent recorded inspection, by US FDA, closed on 31 March 2023 as VAI. Customs aggregates show $16.1M of exports covering 338 molecules to 39 destinations in 2025.

32
active US DMFs
11
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

  • 31 March 2023 VAI US FDA
  • 11 March 2016 NAI US FDA
  • 30 August 2013 VAI US FDA

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

Registered plants

Site FDA FEI
Bibinagar Village, India Not on file
Yadadri Bhuvanagiri District, India 3008822771

What they file, and where

Molecule Regulators Docs
Rivastigmine EDQM, US FDA 6
Tadalafil EDQM, SFDA (Saudi Arabia), US FDA 5
Ticagrelor EDQM, SFDA (Saudi Arabia), US FDA 5
Febuxostat SFDA (Saudi Arabia), US FDA 4
Perampanel SFDA (Saudi Arabia), US FDA 4
Triethylenetetramine SFDA (Saudi Arabia), US FDA 3
Asenapine US FDA 2
Atomoxetine EDQM, US FDA 2
Dimethyl SFDA (Saudi Arabia) 2
Fosfomycin US FDA 2
Show all 26 molecules on file
Parecoxib SFDA (Saudi Arabia), US FDA 2
Pioglitazone SFDA (Saudi Arabia), US FDA 2
Sildenafil SFDA (Saudi Arabia), US FDA 2
Topiramate EDQM, US FDA 2
Belumosudil US FDA 1
Cinacalcet US FDA 1
Clopidogrel US FDA 1
Clopidogrel Hydrogen Sulfate EDQM 1
Iloperidone US FDA 1
Lansoprazole US FDA 1
Pioglitazone Hydrochloride EDQM 1
Prazosin US FDA 1
Sildenafil Citrate EDQM 1
Tapentadol US FDA 1
Tapinarof US FDA 1
Vibegron US FDA 1

Also appears on these molecule pages

Asenapine API Atomoxetine API Cinacalcet API Febuxostat API Fosfomycin API Iloperidone API Lansoprazole API Perampanel API Pioglitazone API Prazosin API Rivastigmine API Sildenafil API
Show 8 more molecule pages
Tadalafil API Tapentadol API Ticagrelor API Topiramate API Triethylenetetramine API Vibegron API Clopidogrel API Dimethyl API

Filings and GMP by regulator

Regulator Filings GMP certificates
CDSCO (India) 1 None

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $2.6M 22
2025 Not reported $16.1M 39
2024 Not reported $20.4M 42
2023 Not reported $14.8M 35

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

Questions about MSN Organics

Does MSN Organics hold a US DMF or a CEP?
MSN Organics holds 32 active US drug master files and 11 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 MSN Organics FDA-registered?
One site operated by MSN Organics 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 MSN Organics's last inspection go?
The most recent inspection on record closed on 31 March 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file.
Where does MSN Organics manufacture?
2 registered sites are on record, in India (Bibinagar Village and Yadadri Bhuvanagiri District). Every site is listed on this page with the register it came from.
What does MSN Organics make?
26 molecules are on record against MSN Organics, including Rivastigmine, Tadalafil, Ticagrelor and Febuxostat. Each links through to that molecule's full manufacturer list.
Where does MSN Organics file?
Filings are on record with CDSCO (India), 1 in total.

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

  • 2 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 31 March 2023.

Comparable suppliers

Dr Reddy's Laboratories shares 11 molecules Apitoria Pharma shares 9 molecules Macleods Pharmaceuticals shares 9 molecules Zydus Lifesciences shares 8 molecules Matrix Pharmacorp shares 7 molecules

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
Customs aggregates
Export values, molecule and destination counts