Suppliers / Shenzhen Oriental Pharmaceutical

Shenzhen Oriental Pharmaceutical

China Updated 9 July 2026

Shenzhen Oriental Pharmaceutical is a contract manufacturer based in China. It holds one active US drug master file. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 29 November 2024 as NAI.

1
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
Inspections
4 of 4 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 29 November 2024 NAI US FDA
  • 11 January 2019 VAI US FDA
  • 7 June 2016 VAI US FDA
  • 20 March 2014 VAI US FDA

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

Registered plants

Site FDA FEI
China, China 3003677845

What they file, and where

Molecule Regulators Docs
Doxylamine US FDA 1

Also appears on these molecule pages

Doxylamine contract manufacturing Epinephrine contract manufacturing Norepinephrine contract manufacturing Phenylephrine contract manufacturing Raltegravir contract manufacturing Rivastigmine contract manufacturing Selegiline contract manufacturing

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Shenzhen Oriental Pharmaceutical

Does Shenzhen Oriental Pharmaceutical hold a US DMF or a CEP?
Shenzhen Oriental Pharmaceutical holds 1 active US drug master file. 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 Shenzhen Oriental Pharmaceutical FDA-registered?
One site operated by Shenzhen Oriental Pharmaceutical 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 Shenzhen Oriental Pharmaceutical's last inspection go?
The most recent inspection on record closed on 29 November 2024 as NAI (No Action Indicated: nothing objectionable was found). 4 inspections are on file.
Where does Shenzhen Oriental Pharmaceutical manufacture?
1 registered site is on record, in China (China). Every site is listed on this page with the register it came from.
What does Shenzhen Oriental Pharmaceutical make?
1 molecule is on record against Shenzhen Oriental Pharmaceutical, including Doxylamine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Shenzhen Oriental Pharmaceutical's GMP?
Current GMP certificates are on record from 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 NAI, on 29 November 2024.

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