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First production of MonoEmbolex

Manufacturing Capabilites

Primary sites

PRIMARY SITES

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, FMHACA, GCC, ICHA, MCAZ, MHRA, NAFDAC, NDA, PMPB, PPB, SAHPRA, TFDA, 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:

MCC and PIC/S.

Sterile facility SVP 1: multi-product suites A and B

Capability:

Eye drops, ampoules, vials; aseptic and terminal sterilisation 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:

LAsD, SAHPRA, US FDA, WHO.

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) – (commercial production FY2020)

Accreditation:

ANSM, ANVISA, ASN, DQS, HPB, PMDA, US FDA.

Unit 2 facility

Capability:

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

Maximum output:

4 billion tablets.

Accreditation:

ANVISA, FMHACA, GCC, ICHA, MCAZ, MCC, MHRA, NAFDA, NDA, PIC/S, PMPB, PPB, TFDA, TGA, US FDA, WHO.

Unit 4 facility

Capability:

Hormonal and highpotency solids manufacturing and packaging for the domestic and export markets.

Maximum output:

3,2 billion tablets (hormonal);
395 million tablets (potency).

Accreditation:

LAsD, SAHPRA. and US FDA.

Sterile facility SVP 2: high-potency suite

(commercial production FY2021)

Capability:

Liquid ampoules, vials and cartridges; emulsion ampoules, vials and cartridges; lyophilised vials; aseptic and terminal sterilisation capability for domestic and export markets.

Maximum output:

Suite C:
Up to 20 million vials;
Up to 25 million ampoules;
Up to 13 million cartridges.

Accreditation:

Regulatory inspections pending (project phase). LAsD tentatively planned, SAHPRA and TGA planned.

Bad Oldesloe, Germany

MULTI-DOSE FORM SITE

(Additional commercial production FY2021)

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, LRA, PPB, PMDA, TGA, US FDA.

API facilities
Regional facilities

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

Our strategic objective of supplying high quality, efficacious, affordable medicines and products 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 injectables, oral solid, semi-solid, liquids, steriles, biologicals and API manufacturing. Our niche and complex production capabilities provide a strategic advantage in an increasingly commoditised environment. An overview of the Group's strategic manufacturing capabilities is set out on Our manufacturing capabilities. Carrying value of property, plant and equipment (R12 065 million)

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 IT 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 442 million (2018: R2 145 million) with a further R2 600 million planned for 2020. The level of capital expenditure is forecast to reduce significantly from the 2021 financial year.

Following the Anaesthetic transactions with AstraZeneca and GSK, we have integrated the manufacturing sites responsible for the supply of some of these products into our supply chain network, which provides us with a strategic opportunity to pursue manufacturing synergies. Significant capital projects are in progress at the Port Elizabeth, Notre Dame de Bondeville and Bad Oldesloe sites in order to transfer the manufacture from AstraZeneca, GSK and some external supply contract manufacturing sites. The expected first commercial production at the Port Elizabeth and Bad Oldesloe sites is in the 2021 financial year with Notre Dame de Bondeville following in the 2022 financial year. Full commercial benefit from this strategic investment of R4,9 billion in total is expected in the 2024 financial year.

Major projects underway to enable Aspen to manufacture anaesthetics

  • Port Elizabeth - steriles
  • Notre Dame de Bondeville – blow-fill seal
  • Bad Oldesloe – creams, gels, liquids
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PPE Capital Expenditure - R'million

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Approximately R2.8bn of PPE capex is also authorised for investment after FY 2019

  • Planned capex is based on current expectations that no new strategic capex programmeswill be undertaken in the next 3 years
  • Maintenance capex generally between R400-500 million p.a.
  • Total capex on strategic projects has increased from R4.5 billion to R4.9 billion largely due to unfavourable forex adjustments

Primary Sites

  • Site-specific centres of production excellence
  • Large-scale capabilities leading to COGS benefits
  • Ensures uniform quality globally
  • Specialist capabilities and skills
  • Provide overall strategic advantage for Group
  • Globally accredited
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SOUTH AFRICA: One of our flagship manufacturing sites in Port Elizabeth, South Africa

API Facilities

  • Biological capabilities including heparin where Aspen has become a significant global player
  • Capabilities include biochemicals, peptides, steroid/hormones, high potency products and other chemicals
  • Manufacturing capabilities enable control and access over niche pipeline opportunites
  • Provides vertical integration advantage for Group
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FRANCE: Our Notre Dame de Bondeville specialist sterile manufacturing site in Rouen, France

Regional Facilities

  • Supply local/regional needs across diverse territories
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