Suppliers / Hisun Pharmaceutical

Hisun Pharmaceutical

China reconciled across 10 public records · 6 entities Updated 9 July 2026

Hisun Pharmaceutical is an API manufacturer based in China. It holds 22 valid CEPs across a filed portfolio of 26 molecules. Its filings concentrate with US FDA and MINSA (CR). Its GMP standing is certified by MFDS (Korea), EMA and DRAP (PK).

0
active US DMFs
22
valid CEPs
5
registered plants
17
filings across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
EU GMP
1 of 1 confirmed
Sources: EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Registered plants

Site FDA FEI
Hangzhou City, China Not on file
Nantong City, China Not on file
Taizhou, China Not on file
Taizhou City, China Not on file
gadoon, Pakistan Not on file

What they file, and where

Molecule Regulators Docs
Daunorubicin EDQM, SFDA (Saudi Arabia) 2
Ivermectin EDQM 2
Acarbose EDQM 1
Adenosine EDQM 1
Bleomycin SFDA (Saudi Arabia) 1
Bleomycin Sulfate EDQM 1
Cytarabine SFDA (Saudi Arabia) 1
Dactinomycin SFDA (Saudi Arabia) 1
Doxorubicin EDQM 1
Doxorubicin Hydrochloride EDQM 1
Show all 26 molecules on file
Epirubicin EDQM 1
Everolimus EDQM 1
Fipronil For Veterinary Use EDQM 1
Lovastatin EDQM 1
Methotrexate SFDA (Saudi Arabia) 1
Milbemycin Oxime For Veterinary Use EDQM 1
Mitomycin EDQM 1
Moxidectin For Veterinary Use EDQM 1
Mycophenolate Mofetil EDQM 1
Pravastatin EDQM 1
Praziquantel EDQM 1
Simvastatin EDQM 1
Tacrolimus EDQM 1
Ticagrelor EDQM 1
Tigecycline EDQM 1
Vinorelbine SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Acarbose API Adenosine API Cytarabine API Daunorubicin API Doxorubicin API Epirubicin API Ivermectin API Lovastatin API Methotrexate API Pravastatin API Simvastatin API Tigecycline API
Show 2 more molecule pages
Vinorelbine API Ticagrelor API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 16 None
MINSA (CR) 1 None
MFDS (Korea) None 2
EMA None 1
DRAP (PK) None 1

Questions about Hisun Pharmaceutical

Does Hisun Pharmaceutical hold a US DMF or a CEP?
Hisun Pharmaceutical holds 22 valid CEPs. 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.
Where does Hisun Pharmaceutical manufacture?
5 registered sites are on record, in China and Pakistan (Hangzhou City, Nantong City and Taizhou among others). Every site is listed on this page with the register it came from.
What does Hisun Pharmaceutical make?
26 molecules are on record against Hisun Pharmaceutical, including Daunorubicin, Ivermectin, Acarbose and Adenosine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Hisun Pharmaceutical's GMP?
Current GMP certificates are on record from MFDS (Korea), EMA and DRAP (PK). 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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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