Suppliers / SMS Pharmaceuticals

SMS Pharmaceuticals

India SMSPHARMA.NS 493 employees Updated 9 July 2026

SMS Pharmaceuticals is an API and finished-dose manufacturer based in India. It holds 37 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.

37
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

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

Registered plants

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

What they file, and where

Molecule Regulators Docs
Ibuprofen EDQM, US FDA 6
Famotidine EDQM, SFDA (Saudi Arabia), US FDA 4
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
Eletriptan US FDA 2
Itraconazole EDQM, US FDA 2
Lamivudine EDQM, US FDA 2
Lamotrigine EDQM, US FDA 2
Show all 30 molecules on file
Levetiracetam EDQM, US FDA 2
Pirfenidone EDQM, US FDA 2
Ranitidine EDQM, US FDA 2
Sildenafil EDQM, US FDA 2
Solifenacin Succinate EDQM, US FDA 2
Sumatriptan US FDA 2
Tadalafil EDQM, US FDA 2
Vardenafil EDQM, US FDA 2
Almotriptan US FDA 1
Almotriptan Malate EDQM 1
Apixaban US FDA 1
Clozapine US FDA 1
Deferasirox US FDA 1
Dexibuprofen US FDA 1
Efavirenz US FDA 1
Escitalopram US FDA 1
Hydroxychloroquine US FDA 1
Imidapril US FDA 1
Molnupiravir US FDA 1
Paliperidone SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Show 5 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
BRELA (TZ) 1 None
NMRC (NA) 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.

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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