Suppliers / Sharon Bio-Medicine

Sharon Bio-Medicine

India 414 employees Updated 9 July 2026

Sharon Bio-Medicine is an API manufacturer based in India. It holds 5 active US drug master files and one valid CEP across a filed portfolio of 7 molecules. Its filings concentrate with DAV (Vietnam), ARCSA (EC) and MINSA (CR). Its GMP standing is certified by EMA and MHRA (UK). Its most recent recorded inspection, by US FDA, closed on 22 February 2019 as VAI. Customs aggregates show $21.8M of exports covering 1,058 molecules to 27 destinations in 2025.

5
active US DMFs
1
valid CEPs
4
registered plants 1 with an FDA FEI number
14
filings across 3 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
2 of 2 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

  • 22 February 2019 VAI US FDA
  • 7 July 2015 VAI US FDA

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

Registered plants

Site FDA FEI
UTTARAKHAND, India Not on file
Navi Mumbai, India Not on file
Raigad, India 3004455093
Dehradun, India Not on file

What they file, and where

Molecule Regulators Docs
Trimetazidine Dihydrochloride EDQM, SFDA (Saudi Arabia) 2
Eperisone SFDA (Saudi Arabia) 1
Ketoconazole US FDA 1
Memantine US FDA 1
Moxifloxacin US FDA 1
Nifedipine US FDA 1
Telmisartan US FDA 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
DAV (Vietnam) 9 None
ARCSA (EC) 3 None
MINSA (CR) 2 None
EMA None 1
MHRA (UK) None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $3.2M 15
2025 Not reported $21.8M 27
2024 Not reported $17.5M 28
2023 Not reported $15.4M 25

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 We do not publish the identity of any buyer.

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Open risk flags

  • The most recent inspection outcome was VAI, on 22 February 2019.

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