Suppliers / Bora Pharmaceuticals

Bora Pharmaceuticals

Taiwan 712 employees Updated 9 July 2026

Bora Pharmaceuticals is a finished-dose manufacturer based in Taiwan. It appears in 13 regulatory filings across 2 regulators, without an active US DMF or CEP on file. Its filings concentrate with DIGEMAPS (DO) and NPRA (MY). Its most recent recorded inspection, by US FDA, closed on 30 August 2022 as VAI.

0
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
13
filings across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 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 August 2022 VAI US FDA
  • 19 December 2018 VAI US FDA
  • 21 June 2018 NAI US FDA
  • 10 December 2015 NAI US FDA
  • 3 March 2014 VAI US FDA
  • 1 March 2013 VAI US FDA
  • 28 February 2011 NAI US FDA
  • 22 February 2011 VAI US FDA

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

Registered plants

Site FDA FEI
Maple Grove, United States 3004106442

Filings and GMP by regulator

Regulator Filings GMP certificates
DIGEMAPS (DO) 12 None
NPRA (MY) 1 None

Questions about Bora Pharmaceuticals

Does Bora Pharmaceuticals hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Bora Pharmaceuticals. It does have 13 filings with 2 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Bora Pharmaceuticals FDA-registered?
One site operated by Bora Pharmaceuticals 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 Bora Pharmaceuticals's last inspection go?
The most recent inspection on record closed on 30 August 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Bora Pharmaceuticals manufacture?
1 registered site is on record, in United States (Maple Grove). Every site is listed on this page with the register it came from.
Where does Bora Pharmaceuticals file?
Filings are on record with DIGEMAPS (DO) and NPRA (MY), 13 in total.

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 August 2022.

Comparable suppliers

Bora Pharmaceutical Laboratories also in Taiwan Lotus Pharmaceutical Co Ltd Nantou Plant also in Taiwan Lotus Pharmaceutical also in Taiwan Nang Kuang Pharmaceutical also in Taiwan Tty Biopharm also in Taiwan

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