Suppliers / Lilly Del Caribe

Lilly Del Caribe

Puerto Rico 8 employees Updated 9 July 2026

Lilly Del Caribe is a finished-dose manufacturer based in Puerto Rico. It appears in 21 regulatory filings across 1 regulator, without an active US DMF or CEP on file. Its GMP standing is certified by ANVISA (Brazil) and US FDA. Its most recent recorded inspection, by US FDA, closed on 30 January 2026 as VAI.

0
active US DMFs
0
valid CEPs
4
registered plants 2 with an FDA FEI number
21
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 30 January 2026 VAI US FDA
  • 17 February 2023 VAI US FDA
  • 25 February 2022 VAI US FDA
  • 12 July 2019 VAI US FDA
  • 27 September 2018 NAI US FDA
  • 21 September 2018 VAI US FDA
  • 21 July 2017 VAI US FDA
  • 1 June 2016 VAI US FDA

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

Registered plants

Site FDA FEI
CAROLINA, Puerto Rico Not on file
(PR02) Carolina, United States Not on file
Carolina, United States 3004525072
Carolina, United States 2619243

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 21 None
ANVISA (Brazil) None 1
US FDA None 1

Questions about Lilly Del Caribe

Does Lilly Del Caribe hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Lilly Del Caribe. It does have 21 filings with one regulator, so it is registered, just not with the two strong registers buyers usually screen on.
Is Lilly Del Caribe FDA-registered?
2 sites operated by Lilly Del Caribe carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Lilly Del Caribe's last inspection go?
The most recent inspection on record closed on 30 January 2026 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Lilly Del Caribe manufacture?
4 registered sites are on record, in Puerto Rico and United States (Carolina, (pr02) Carolina and Carolina among others). Every site is listed on this page with the register it came from.
Which regulators recognise Lilly Del Caribe's GMP?
Current GMP certificates are on record from ANVISA (Brazil) and 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 30 January 2026.

Comparable suppliers

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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
EudraGMDP and national regulators
GMP certificates