Suppliers / Hainan Shuangcheng Pharmaceuticals

Hainan Shuangcheng Pharmaceuticals

China 30 employees Updated 9 July 2026

Hainan Shuangcheng Pharmaceuticals is an API manufacturer based in China. It holds 7 active US drug master files and one valid CEP across a filed portfolio of 8 molecules. Its filings concentrate with US FDA and SFDA (Saudi Arabia). Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 26 January 2024 as VAI.

7
active US DMFs
1
valid CEPs
2
registered plants 1 with an FDA FEI number
2
filings across 2 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

  • 26 January 2024 VAI US FDA
  • 24 April 2019 VAI US FDA
  • 28 January 2016 VAI US FDA
  • 22 August 2013 VAI US FDA

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

Registered plants

Site FDA FEI
Haikou City, China Not on file
China, China 3009010397

What they file, and where

Molecule Regulators Docs
Bivalirudin SFDA (Saudi Arabia), US FDA 2
Bortezomib US FDA 1
Eptifibatide US FDA 1
Linaclotide US FDA 1
Octreotide US FDA 1
Somatostatin EDQM 1
Triptorelin US FDA 1
Vasopressin US FDA 1

Also appears on these molecule pages

Bivalirudin API Bortezomib API Eptifibatide API Linaclotide API Octreotide API Somatostatin API Triptorelin API Vasopressin API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 1 1
SFDA (Saudi Arabia) 1 None

Questions about Hainan Shuangcheng Pharmaceuticals

Does Hainan Shuangcheng Pharmaceuticals hold a US DMF or a CEP?
Hainan Shuangcheng Pharmaceuticals holds 7 active US drug master files and 1 valid CEP. 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 Hainan Shuangcheng Pharmaceuticals FDA-registered?
One site operated by Hainan Shuangcheng 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 Hainan Shuangcheng Pharmaceuticals's last inspection go?
The most recent inspection on record closed on 26 January 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Hainan Shuangcheng Pharmaceuticals manufacture?
2 registered sites are on record, in China (Haikou City and China). Every site is listed on this page with the register it came from.
What does Hainan Shuangcheng Pharmaceuticals make?
8 molecules are on record against Hainan Shuangcheng Pharmaceuticals, including Bivalirudin, Bortezomib, Eptifibatide and Linaclotide. Each links through to that molecule's full manufacturer list.
Which regulators recognise Hainan Shuangcheng Pharmaceuticals'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 VAI, on 26 January 2024.

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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