Suppliers / RioCare India

RioCare India

India Updated 9 July 2026

RioCare India is an API manufacturer based in India. It holds 12 active US drug master files across a filed portfolio of 3 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 1 March 2024 as VAI. Customs aggregates show $4.6M of exports covering 279 molecules to 47 destinations in 2025.

12
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
2 of 2 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 1 March 2024 VAI US FDA
  • 24 February 2017 VAI US FDA

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

Registered plants

Site FDA FEI
Navi Mumbai, India 3005502733

What they file, and where

Molecule Regulators Docs
Simethicone US FDA 9
Dimethicone US FDA 3
Activated Dimethicone SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $790K 26
2025 Not reported $4.6M 47
2024 Not reported $4.6M 48
2023 Not reported $5.3M 45

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 We do not publish the identity of any buyer.

Questions about RioCare India

Does RioCare India hold a US DMF or a CEP?
RioCare India holds 12 active US drug master files. 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 RioCare India FDA-registered?
One site operated by RioCare India 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 RioCare India's last inspection go?
The most recent inspection on record closed on 1 March 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 2 inspections are on file.
Where does RioCare India manufacture?
1 registered site is on record, in India (Navi Mumbai). Every site is listed on this page with the register it came from.
What does RioCare India make?
3 molecules are on record against RioCare India, including Simethicone, Dimethicone and Activated Dimethicone. Each links through to that molecule's full manufacturer list.
Which regulators recognise RioCare India's GMP?
Current GMP certificates are on record from 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 1 March 2024.

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