Suppliers / Strem Chemicals

Strem Chemicals

United States Updated 9 July 2026

Strem Chemicals is an API manufacturer based in United States. It holds 2 active US drug master files across a filed portfolio of 2 molecules. Its most recent recorded inspection, by US FDA, closed on 30 July 2025 as OAI.

2
active US DMFs
0
valid CEPs
2
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
7 of 7 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 30 July 2025 OAI US FDA
  • 27 January 2020 NAI US FDA
  • 21 September 2017 VAI US FDA
  • 24 March 2016 VAI US FDA
  • 18 April 2014 VAI US FDA
  • 9 December 2011 VAI US FDA
  • 25 February 2010 VAI US FDA

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

Registered plants

Site FDA FEI
Newburyport, United States Not on file
Newburyport, United States 1220700

What they file, and where

Molecule Regulators Docs
Carboplatin US FDA 1
Cisplatin US FDA 1

Also appears on these molecule pages

Carboplatin API Cisplatin API

Questions about Strem Chemicals

Does Strem Chemicals hold a US DMF or a CEP?
Strem Chemicals 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 Strem Chemicals FDA-registered?
One site operated by Strem Chemicals 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 Strem Chemicals's last inspection go?
The most recent inspection on record closed on 30 July 2025 as OAI (Official Action Indicated, the worst classification: objectionable conditions were found and regulatory action was warranted). 7 inspections are on file, of which 1 closed as OAI.
Where does Strem Chemicals manufacture?
2 registered sites are on record, in United States (Newburyport among others). Every site is listed on this page with the register it came from.
What does Strem Chemicals make?
2 molecules are on record against Strem Chemicals, including Carboplatin and Cisplatin. 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 OAI, on 30 July 2025.

Comparable suppliers

Hetero shares 2 molecules Cipla shares 2 molecules Laurus Labs shares 2 molecules Veranova Lp shares 2 molecules Qilu Pharmaceutical shares 2 molecules

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