Suppliers / Purolite

Purolite

United States Updated 9 July 2026

Purolite is an API manufacturer based in United States. It holds 2 active US drug master files across a filed portfolio of 3 molecules.

2
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
Sources: FDA Establishment Registration, read 4 May 2026.

Registered plants

Site FDA FEI
King of Prussia, United States 3030504602

What they file, and where

Molecule Regulators Docs
Calcium Polystyrene SFDA (Saudi Arabia) 1
Cholestyramine US FDA 1
Tolevamer US FDA 1

Also appears on these molecule pages

Cholestyramine API

Questions about Purolite

Does Purolite hold a US DMF or a CEP?
Purolite holds 2 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 Purolite FDA-registered?
One site operated by Purolite 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.
Where does Purolite manufacture?
1 registered site is on record, in United States (King Of Prussia). Every site is listed on this page with the register it came from.
What does Purolite make?
3 molecules are on record against Purolite, including Calcium Polystyrene, Cholestyramine and Tolevamer. 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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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability