Suppliers / Hec Pharm

Hec Pharm

United States 135 employees 2 duplicate records merged Updated 9 July 2026

Hec Pharm is an API and finished-dose manufacturer based in United States. It holds 20 active US drug master files and 3 valid CEPs across a filed portfolio of 19 molecules. Its filings concentrate with AEMPS (ES), EMA and US FDA. Its GMP standing is certified by EMA.

20
active US DMFs
3
valid CEPs
3
registered plants 1 with an FDA FEI number
100
filings across 4 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Registered plants

Site FDA FEI
Yidu, China Not on file
Berlin, Germany Not on file
Plainsboro, United States 3016779715

What they file, and where

Molecule Regulators Docs
Azithromycin SFDA (Saudi Arabia), US FDA 2
Entacapone EDQM, US FDA 2
Erythromycin US FDA 2
Moxifloxacin EDQM, US FDA 2
Olanzapine EDQM, US FDA 2
Atorvastatin US FDA 1
Azilsartan Medoxomil US FDA 1
Clarithromycin US FDA 1
Duloxetine US FDA 1
Escitalopram US FDA 1
Show all 19 molecules on file
Esomeprazole US FDA 1
Febuxostat US FDA 1
Levofloxacin US FDA 1
Lincomycin US FDA 1
Metoprolol US FDA 1
Olmesartan US FDA 1
Tenofovir Disoproxil US FDA 1
Ticagrelor US FDA 1
Zidovudine US FDA 1

Also appears on these molecule pages

Show 5 more molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
AEMPS (ES) 41 None
EMA 27 4
US FDA 27 None
MPA (SE) 5 None

Comparing suppliers?

Choose your molecules and target markets. Hec Pharm comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Open risk flags

  • 5 active litigation matters are on record.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates