Pharmaceutical & API manufacturing sites in South Africa

11 drug establishments in South Africa are registered with the US FDA; 5 (45%) list API manufacture among their operations. 9 registrant companies are identified; sites whose registrant is not resolved to a company profile are not counted. 2 published sites are matched to an EU or UK GMP certificate inspected within the last three years.

Counts are physical site addresses in the FDA's current establishment register (US-facing sites only), not headquarters and not production volume. Methodology

FDA-registered sites
11
Registered for API manufacture
5
Identified registrants
9
Current EU/UK GMP match
2

Registered operations

Drug manufacture8
Packaging6
API manufacture5
Analytical testing5
Labelling4
Sterilisation2
Relabelling1
Repackaging1

A site can register several operations, so these do not add up to the site total.

Companies headquartered in South Africa

API manufacturing sites (5)

Only sites registered with the US FDA appear, so manufacturing that serves only other markets is missing and these figures understate national capacity. A GMP match requires the certificate address to name the site's street and its city or postcode; an unmatched site is not an uncertified site.