Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Pharmaceutical companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in ItalyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Alfasigma and its 3 subsidiaries with 35 510(k) clearances, 3 drug applications and 3 device recalls. The most recent is a 510(k) clearance dated Feb 27, 2018: ACE Hemoglobin A1c (HbA1c) Reagent.
Group recordsLabelled by a language model (which subsidiaries belong to the group) from the firm's FDA names. It is not an FDA field.: 41, 4 entities
510(k) clearances: 35
Drug applications: 3
Device recalls: 3
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Alfasigma and its 3 subsidiaries
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
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120262026 to dateRecords1
Latest Records
Newest first across sources; each opens the record
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata.How this page is built
