Suppliers / Aspen Sa Operations (Pty)

Aspen Sa Operations (Pty)

South Africa Updated 9 July 2026

Aspen Sa Operations (Pty) is a finished-dose manufacturer based in South Africa. It appears in 18 regulatory filings across 6 regulators, without an active US DMF or CEP on file. Its filings concentrate with NPRA (MY), EDE (AE) and SAHPRA (ZA). Its GMP standing is certified by SAHPRA (ZA) and ANVISA (Brazil).

0
active US DMFs
0
valid CEPs
3
registered plants
18
filings across 6 regulators

Registered plants

Site FDA FEI
Gqeberha, United Arab Emirates Not on file
GQEBERHA, South Africa Not on file
East London, South Africa Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
NPRA (MY) 6 None
EDE (AE) 4 None
SAHPRA (ZA) 4 6
BOMRA (BW) 2 None
INVIMA (CO) 1 None
MINSA (CR) 1 None
ANVISA (Brazil) None 1

Questions about Aspen Sa Operations (Pty)

Does Aspen Sa Operations (Pty) hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Aspen Sa Operations (Pty). It does have 18 filings with 6 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does Aspen Sa Operations (Pty) manufacture?
3 registered sites are on record, in United Arab Emirates and South Africa (Gqeberha, Gqeberha and East London). Every site is listed on this page with the register it came from.
Which regulators recognise Aspen Sa Operations (Pty)'s GMP?
Current GMP certificates are on record from SAHPRA (ZA) and ANVISA (Brazil). 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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Sources on this page

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