Suppliers / Waterstone Pharmaceuticals (Hubei)

Waterstone Pharmaceuticals (Hubei)

China 21 employees Updated 9 July 2026

Waterstone Pharmaceuticals (Hubei) is an API manufacturer based in China. It holds 3 active US drug master files across a filed portfolio of 3 molecules. Its most recent recorded inspection, by US FDA, closed on 29 September 2021 as VAI.

3
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

  • 29 September 2021 VAI US FDA
  • 20 January 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
China, China 3010777606

What they file, and where

Molecule Regulators Docs
Colesevelam US FDA 1
Deferasirox US FDA 1
Sevelamer US FDA 1

Also appears on these molecule pages

Colesevelam API Sevelamer API Deferasirox API

Questions about Waterstone Pharmaceuticals (Hubei)

Does Waterstone Pharmaceuticals (Hubei) hold a US DMF or a CEP?
Waterstone Pharmaceuticals (Hubei) holds 3 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 Waterstone Pharmaceuticals (Hubei) FDA-registered?
One site operated by Waterstone Pharmaceuticals (Hubei) 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 Waterstone Pharmaceuticals (Hubei)'s last inspection go?
The most recent inspection on record closed on 29 September 2021 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 2 inspections are on file.
Where does Waterstone Pharmaceuticals (Hubei) manufacture?
1 registered site is on record, in China (China). Every site is listed on this page with the register it came from.
What does Waterstone Pharmaceuticals (Hubei) make?
3 molecules are on record against Waterstone Pharmaceuticals (Hubei), including Colesevelam, Deferasirox and Sevelamer. Each links through to that molecule's full manufacturer list.

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 29 September 2021.

Comparable suppliers

Apitoria Pharma shares 2 molecules Solara Active Pharma Sciences shares 2 molecules Formosa Laboratories shares 2 molecules Navinta shares 2 molecules Hetero shares 1 molecule

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