Suppliers / Aspen

Aspen

South Africa 2 duplicate records merged Updated 9 July 2026

Aspen is an API and finished-dose manufacturer based in South Africa. It appears in 547 regulatory filings across 18 regulators, without an active US DMF or CEP on file. Its filings concentrate with INHRR (VE), INVIMA (CO) and MHRA (UK). Its GMP standing is certified by COFEPRIS (MX) and NAFDAC (NG).

0
active US DMFs
0
valid CEPs
3
registered plants
547
filings across 18 regulators

Registered plants

Site FDA FEI
Port Elizabeth, United Arab Emirates Not on file
Azcapotzalco, Mexico Not on file
Cnr. Fairclough Road & gibaud Road Korsten port Elizabeth South Africa, Nigeria Not on file

What they file, and where

Molecule Regulators Docs
Progesterone SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Ambrisentan finished dose Azathioprine finished dose Busulfan finished dose Cefalotin finished dose Cisatracurium finished dose Darifenacin finished dose Doxazosin finished dose Eletriptan finished dose Fondaparinux finished dose Gefitinib finished dose Labetalol finished dose Lercanidipine finished dose
Show 12 more molecule pages
Melphalan finished dose Nevirapine finished dose Oxacillin finished dose Palbociclib finished dose Pomalidomide finished dose Pramipexole finished dose Prilocaine finished dose Progesterone API Remifentanil finished dose Ritonavir finished dose Teicoplanin finished dose Tirofiban finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
INHRR (VE) 267 None
INVIMA (CO) 60 None
MHRA (UK) 59 None
DKMA (DK) 37 None
US FDA 33 None
ANMAT (AR) 20 None
COFEPRIS (MX) None 2
NAFDAC (NG) None 2

Questions about Aspen

Does Aspen hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Aspen. It does have 547 filings with 18 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does Aspen manufacture?
3 registered sites are on record, in United Arab Emirates, Mexico and Nigeria (Port Elizabeth, Azcapotzalco and Cnr. Fairclough Road & Gibaud Road Korsten Port Elizabeth South Africa). Every site is listed on this page with the register it came from.
What does Aspen make?
1 molecule is on record against Aspen, including Progesterone. Each links through to that molecule's full manufacturer list.
Which regulators recognise Aspen's GMP?
Current GMP certificates are on record from COFEPRIS (MX) and NAFDAC (NG). 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.

Comparing suppliers?

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

Start for free
No sales call.

Open risk flags

  • 7 active litigation matters are on record.

Comparable suppliers

Industriale Chimica shares 1 molecule Symbiotec Pharmalab shares 1 molecule F.I.S. Fabbrica Italiana Sintetici shares 1 molecule Aspen Oss shares 1 molecule zhejiang xianju pharmaceutical shares 1 molecule

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