Suppliers / SMS Pharmaceuticals

SMS Pharmaceuticals

India SMSPHARMA.NS 493 employees reconciled across 4 public records · 1 entities Updated 9 July 2026

SMS Pharmaceuticals is an API manufacturer based in India. It holds 41 active US drug master files and 22 valid CEPs. Its filings concentrate with NPRA (MY), CDSCO (India) and MCAZ (ZW). Its GMP standing is certified by US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 12 December 2025 as OAI. Customs aggregates show $34.6M of exports covering 387 molecules to 50 destinations in 2025.

41
active US DMFs
22
valid CEPs
3
registered plants 3 with an FDA FEI number
159
filings across 6 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

  • 12 December 2025 OAI US FDA
  • 25 June 2025 NAI US FDA
  • 21 March 2025 VAI US FDA
  • 5 March 2020 NAI US FDA
  • 17 January 2020 VAI US FDA
  • 17 November 2017 NAI US FDA
  • 24 April 2015 NAI US FDA
  • 18 April 2014 VAI US FDA
  • 27 July 2012 NAI US FDA
  • 4 February 2011 NAI US FDA

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

Registered plants

Site FDA FEI
Hyderabad, India 3003971663
Vizianagaram, India 3008654585
Hyderabad, India 3014615000

What they file, and where

Molecule Regulators Docs
Ibuprofen EDQM, US FDA 6
Famotidine EDQM, SFDA (Saudi Arabia), US FDA 5
Pantoprazole EDQM, SFDA (Saudi Arabia), US FDA 4
Aripiprazole EDQM, SFDA (Saudi Arabia), US FDA 3
Ondansetron EDQM, SFDA (Saudi Arabia), US FDA 3
Rizatriptan EDQM, SFDA (Saudi Arabia), US FDA 3
Sildenafil EDQM, SFDA (Saudi Arabia), US FDA 3
Tadalafil EDQM, SFDA (Saudi Arabia), US FDA 3
Eletriptan US FDA 2
Itraconazole EDQM, US FDA 2
Show all 40 molecules on file
Lamivudine EDQM, US FDA 2
Lamotrigine EDQM, US FDA 2
Levetiracetam EDQM, US FDA 2
Pirfenidone EDQM, US FDA 2
Ranitidine EDQM, US FDA 2
Solifenacin Succinate EDQM, US FDA 2
Sumatriptan US FDA 2
Vardenafil EDQM, US FDA 2
Almotriptan US FDA 1
Almotriptan Malate EDQM 1
Apixaban US FDA 1
Cimetidine US FDA 1
Clozapine US FDA 1
Deferasirox US FDA 1
Dexibuprofen US FDA 1
Efavirenz US FDA 1
Escitalopram US FDA 1
Furosemide US FDA 1
Hydroxychloroquine US FDA 1
Imidapril US FDA 1
Minoxidil US FDA 1
Molnupiravir US FDA 1
Paliperidone SFDA (Saudi Arabia) 1
Penciclovir US FDA 1
Rivaroxaban US FDA 1
Rosiglitazone US FDA 1
Sildenafil Citrate EDQM 1
Sitagliptin SFDA (Saudi Arabia) 1
Sumatriptan Succinate EDQM 1
Zolmitriptan US FDA 1

Also appears on these molecule pages

Show 17 more molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
NPRA (MY) 142 None
CDSCO (India) 7 None
MCAZ (ZW) 6 None
BOMRA (BW) 2 None
NMRC (NA) 1 None
BRELA (TZ) 1 None
US FDA None 2
EMA None 2

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $1.6M 24
2025 $89.9M $34.6M 50
2024 $84.7M $36.1M 40
2023 $63.2M $35.5M 44

Export figures are customs aggregates. We do not publish the identity of any buyer. Revenue shown in US dollars, converted from the reported currency.

Questions about SMS Pharmaceuticals

Does SMS Pharmaceuticals hold a US DMF or a CEP?
SMS Pharmaceuticals holds 41 active US drug master files and 22 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 SMS Pharmaceuticals FDA-registered?
3 sites operated by SMS Pharmaceuticals 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 SMS Pharmaceuticals's last inspection go?
The most recent inspection on record closed on 12 December 2025 as OAI (Official Action Indicated, the worst classification: objectionable conditions were found and regulatory action was warranted). 10 inspections are on file, of which 1 closed as OAI.
Where does SMS Pharmaceuticals manufacture?
3 registered sites are on record, in India (Hyderabad and Vizianagaram among others). Every site is listed on this page with the register it came from.
What does SMS Pharmaceuticals make?
40 molecules are on record against SMS Pharmaceuticals, including Ibuprofen, Famotidine, Pantoprazole and Aripiprazole. Each links through to that molecule's full manufacturer list.
Which regulators recognise SMS Pharmaceuticals's GMP?
Current GMP certificates are on record from US FDA and EMA. 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

  • 1 active litigation matter is on record.
  • The most recent inspection outcome was OAI, on 12 December 2025.

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
Company filings
Revenue as reported