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TEST Manufacturing Capabilities

PORT ELIZABETH, SOUTH AFRICA

UNIT 1 FACILITY

Capability: High-volume solids manufacturing and packing for domestic and export markets.

Maximum output:

6 billion tablets.

Accreditation: ANVISA, EMA, HPRA, ISO 14001, NDA, OHSAS 18001, PMPB, PPB, SAHPRA, SAUDI FDA, TGA, US FDA, WHO.

UNIT 2 FACILITY

Capability: Small to medium-volume solids manufacturing for domestic and export markets.

Maximum output:

4 billion tablets.

Accreditation: ANVISA, EMA, HPRA, ISO 14001, NDA, OHSAS 18001, PMPB, PPB, SAHPRA, SAUDI FDA, TGA, US FDA, WHO.

UNIT 3 FACILITY

Capability: End state packing for domestic market.

Maximum output:

140 million packed units of tablets and capsules.

Accreditation: ISO 14001, OHSAS 18001, SAHPRA.

UNIT 4 FACILITY

Capability: Hormonal and high-potency solids manufacturing and packaging for the domestic and export markets.

Maximum output:

950 million tablets (hormonal); 395 million tablets (potency).

Accreditation: EMA, ISO 14001, LAsD, OHSAS 18001, SAHPRA, TGA, Turkey MoH, US FDA.

STERILE FACILITY SVP 1: MULTI-PRODUCT SUITES A AND B

Capability: Eye drops, ampoules, vials; aseptic and terminal sterilization capability for domestic and export markets.

Maximum output:

Suite A:

Up to 42 million units of eye drops;

Suite B:

Up to 25 million units of ampoules;

Up to 12 million units of liquid vials.

Accreditation:

Suite A: ISO 14001, OHSAS 18001, SAHPRA, TGA, US FDA, WHO.

Suite B: EMA, ISO 14001, LAsD, OHSAS 18001, SAHPRA, TGA, US FDA, WHO.

STERILE FACILITY SVP 2: HIGH-POTENCY SUITE

(Commercial production FY2021)

Capability: Liquid ampoules, vials and cartridges; emulsion ampoules, vials and cartridges; lyophilized vials; aseptic and terminal sterilization capability for domestic and export markets.

Maximum output:

Suite C, D and E:

90 million units (container size and bulk batch dependent).

Accreditation: Regulatory inspections pending (project phase).

LAsD tentatively planned, SAHPRA (all suites) and TGA (suite C).

NOTRE DAME DE BONDEVILLE, FRANCE

STERILE PREFILLED SYRINGE MANUFACTURING SITE

Capability: Aseptic and terminally sterilised prefilled syringe manufacturing and packing for domestic and export markets.

Maximum output:

85 million syringes (Etna line); 130 million syringes (Stromboli line); 180 million syringes (Vesuve line).

Accreditation: ANSM, ANVISA, ASN, HPB, ISO 14001, ISO 45001, ISO 50001, PMDA, US FDA.

NEW ANAESTHETICS FACILITY UNDER CONSTRUCTION

(Commercial production FY2023)

Capability: Aseptic and terminally sterilised blow-fill seal ampoule and polybag manufacturing and packing for domestic and export markets.

BAD OLDESLOE, GERMANY

MULTI-DOSE FORM SITE

(Ramp up of additional commercial production is expected over the next two years and capacity will be included in maximum output below as and when it becomes available)

Capability: Solid dose forms, oral and topical liquids, semi-solids and blow-fill seal, manufacturing and packing for domestic and export markets.

Maximum output:

3,3 billion tablets; 6 240 tonnes of liquids; 1 404 tonnes of topical liquids; 351 tonnes of semi-solids, 60 million units for blow-fill seals.

Accreditation: ANVISA, GRA, IRA, ISO 14001, ISO 45001, ISO 50001, LRA, PPB, PMDA, TGA, US FDA.

MELBOURNE, AUSTRALIA

DANDENONG

Capability: High-volume solids, liquids and semi-solids.

Maximum output: 3 billion tablets; 90 million sachets; 1 167 tonnes semi-solids; 2 200 tonnes liquids.

Accreditation: ISO 14001, OSHAS 18001, TGA.

VITÓRIA, BRAZIL
Capability: Small to medium-volume solids, liquids and semi-solids.

Maximum output: 10,5 Million sealing; 195 million tablets and capsules; 1,5 million bottles of liquids; 912 000 packs of semi-solids.

Accreditation: ANVISA, GMP, ISO 14001, OHSAS 18001.

ACCRA, GHANA
Capability: Small to medium-volume liquids.

Maximum output: 567 kℓ of liquids.

Accreditation: GFDA.

HYDERABAD, INDIA
Capability: Small to medium-volume solids manufacturing for export markets.

Maximum output: 700 million tablets; 30 million effervescent tablets; 120 million capsules; 60 tonnes of pellets; 25 million powder filled sachets.

Accreditation: ANVISA, DCA, ISO 17025, ISO 9001, SAHPRA.

We manufacture a wide variety of product types including steriles, oral solid dose, liquids, semi-solids, biologicals and APIs.

The maximum output is an estimate based on a number of assumptions regarding product mix and complexity, batch size, type and size of products and overall equipment effectiveness.

Sustaining a cost-competitive manufacturing base
Leveraging the Group's diverse and specialist production capabilities

Our strategic objective of supplying high quality, affordable medicines is underpinned by our own manufacturing capabilities and the vertical integration of certain aspects of our supply chain. Our 23 manufacturing facilities present a range of production capabilities and capacities aligned with our current and future commercial objectives. These include steriles, oral solid, semi-solid, liquids, biologicals and API manufacturing. Our niche and complex production capabilities provide a strategic advantage in an increasingly commoditised environment.

During the last year, our strategic manufacturing projects continued to focus on the alignment of our facilities with our manufacturing and commercial strategies, enhancing technology as well as our quality and compliance standards, policies and procedures. Ongoing investment in the upgrading of our world-class manufacturing facilities in addition to the implementation of state-of-the-art electronic systems and Information & Technology capability supports our ability to supply quality products, ensures ongoing compliance to GMP and creates increased manufacturing capacity to meet both current and future operational requirements. Capital expenditure on the replacement and expansion of property, plant and equipment amounted to R2 039 million (2019: R2 442 million) with a further R2 400 million planned for 2021. The level of capital expenditure is forecast to reduce significantly from the 2022 financial year based on the current expectation that limited new strategic capital expansion programmes will be undertaken in the next three years.

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