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Manufacturing Capabilites

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.

Carrying amount of property, plant and equipment (R14 232 million)(%)

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Property, plant and equipment capital expenditure (R'million)

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Following the transactions with AstraZeneca AB and AstraZeneca UK ("AstraZeneca") and GlaxoSmithKline Plc ("GSK") which resulted in the acquisition of our Anaesthetics portfolio, we have transitioned supply from their manufacturing sites into our supply chain network, providing us with a strategic opportunity to pursue 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. First commercial production of these products at the Port Elizabeth facility is scheduled for September 2020, with production being initiated at the Bad Oldesloe and Notre Dame de Bondeville sites in the 2021 and 2022 financial years, respectively. Full commercial benefit from this strategic investment of R4,6 billion (at project budgeted exchange rates) in total is expected in the 2024 financial year.

Oral solid dose manufacturing
We remain focused on increasing the complex manufacturing capability at the Port Elizabeth site. The Bad Oldesloe site's ability to provide specialised and flexible manufacturing and packing capabilities, as well as its favourable location within Europe, bolsters our ability to deliver competitive and bespoke manufacturing solutions. Capacity expansion and continuous improvement projects in respect of these sites are progressing well and delays due to the COVID-19 pandemic are in the process of being recovered, with key projects being:

Port Elizabeth, South Africa

  • Completed the qualification activities and validation batches for the production of Purinethol. Commercial production commenced in the first quarter of FY2020;
  • Continued the projects to implement a Manufacturing Execution System and a Laboratory Information System aimed at achieving additional operational efficiencies;
  • An organisational redesign was initiated to improve efficiency;
  • Increased focus on initiatives to enhance competence at all levels across the site to ensure sustainable performance in the long term;
  • Introduced serialisation capability across the facilities to ensure compliance with the various serialisation requirements globally; and
  • Introduced projects aimed at self-sufficiency in terms of water and electricity supply.

Bad Oldesloe, Germany

  • Introduced aggregation capability to ensure compliance with selected markets;
  • Successful first supply after site-to-site transfer of Eltroxin for Canadian market; and
  • Significant increase of packaging capacity and efficiency for Eltroxin products to meet increasing market demands.

Semi solid and liquid dose manufacturing

Bad Oldesloe, Germany

The extension of the manufacturing and packing lines to accommodate the transfer of anaesthetic liquids, creams and ointments is in progress. The installation and qualification of the following equipment has been completed:

  • A new mixing vessel enhancing efficiency and improving controls;
  • An autoclave for terminal sterilisation of anaesthetic products;
  • A new filling line enhancing efficiency and improving controls;
  • Successful validation of manufacture of the first anaesthetic liquid; and
  • Secondary packaging and successful first supply after site-to-site transfer of Xylocaine Spray.

The installation of a second Blow Fill Seal line, which will significantly increase the production capacity by an additional 120 million sterile single dose poly ampoules per annum, has been approved and is currently underway.

Sterile manufacturing
Our facilities at the Port Elizabeth and Notre Dame de Bondeville sites provide us with extensive sterile manufacturing capability. Capacity expansion plans in respect of these sites have progressed well in the past year:

Port Elizabeth, South Africa

  • Commenced activities to introduce anaesthetics production, a significant step in the evolution of this site. Phases 1 and 2 of the new infrastructure build component is complete and equipment is in the process of being installed and commissioned. Phase 3 is expected to be complete by February 2021. Equipment already installed is undergoing site acceptance testing. The first commercial batches are planned for registration during FY2021. The introduction of these new products is expected to see the export volume for the total South African Operations business move from 20% to over 50% with more than 700 additional stock keeping units ("SKUs") being added to the existing portfolio over the ramp up phase of some four years.

Notre Dame de Bondeville, France

  • Completed the infrastructure build phase of the new suite to manufacture anaesthetic dosage forms comprising polybags and poly ampoules;
  • Continued the installation and qualification of another high-speed prefilled syringe filling line with commercialisation expected by the end of CY2020; and
  • Initiated a project for the installation of a new automatic visual inspection line for prefilled syringes. Qualification and validation is planned to commence in FY2020 with commercialisation expected by the end of FY2021.

API manufacturing
Our API network comprises seven owned facilities, three located in the Netherlands (two in Oss and one in Boxtel), one in the USA (Sioux City), two in France (Notre Dame de Bondeville) and one in South Africa (Cape Town). In addition, we have two API manufacturing blocks situated at Laurus in India. These sites provide Aspen with specialised API capabilities in respect of both our own as well as third party commercial opportunities. The combination of the Oss and Sioux City sites with the Notre Dame de Bondeville site and Port Elizabeth steriles facility provides a fully integrated biochemical supply chain to support some of our Thrombosis portfolio of products. Initiatives to enhance our capacity and improve sustainability at the API sites have continued to receive focus as follows:

Oss, the Netherlands

  • The De Geer site completed the qualification of isolators in the powder handling unit to enable the site to handle high potency APIs;
  • Consolidation, redesign and automation of the laboratories which included the closure of the historical Correllistraat laboratories and the integration of all the laboratories into the Moleneind site (including Polymerase chain reaction for Biochem testing and upgraded laboratories to support the chemical unit) and a further investment in laboratory automation/LIMS software;
  • The Moleneind site completed the validation of a new solvent recovery unit. This unit will contribute to a reduction in waste and will support the site's circular economy objectives by increasing the reuse of solvents;
  • A water circulation unit was installed to improve the site's firefighting capability in line with the site's safety commitments; and
  • An active footprint reduction programme aimed at concentrating activities in core buildings is being implemented at the different sites in the Netherlands as part of the transformation plan.

Notre Dame de Bondeville, France

  • The new certoparin facility obtained regulatory approval from Bfarm and will commence commercial manufacture in the 2021 financial year.

FCC Cape Town, South Africa

  • Commenced full scale commercial manufacture of API in the newly validated high containment/high efficiency production block C2, in support of backward integration projects;
  • Final validation of the recently installed high containment milling and micronising process centre;
  • Concluded the development and optimisation of an anaesthetic API, which will also support backward integration into the Aspen portfolio of products;
  • Concluded phase 1 of product development for strategic backward integration of oncology products;
  • Commissioned and validated a water treatment plant for the use of alternate underground water supply during times of drought/constrained local municipal supply;
  • Concluded the design and placed orders for a new Hazardous Aqueous waste treatment plant and solvent recovery unit, both of which will be installed and commissioned in 2021 and result in significant long-term cost savings; and
  • Continue to upgrade and expand fire prevention and control systems in line with regulatory requirements.

External supply manufacturing network
Our FDF manufacturing network also comprises supply from numerous contract-manufacturing organisations situated globally, several of which are located in Europe. A number of the products manufactured in the external network have been earmarked for transfer to our own manufacturing sites over the next five years. This move will enhance ongoing supply sustainability. We have an internal team of supply chain and quality experts who ensure that all the requisite controls are in place to facilitate supply, on time and in full, and in compliance with our required quality standards.

Reliable supply of quality products
We have commenced a strategic transformational project to create a modern, agile and integrated end-to-end supply chain. The improvement in the links between commercial forecasting and manufacturing, coupled with improved visibility and shared accountability for end-to-end supply chain performance will result in the overall improvement of delivery of quality medicines to patients that need them. This robust process, which will be underpinned by new technology and data tools, improves delivery to patients, reduces service costs, and reduces the risk of stock outs and inventory write-offs.

In response to the global demand for essential medicines during COVID-19 and to manage the various supply and logistics challenges arising, we immediately established a supply chain task force to coordinate our response to ensure the continued supply of products where they were needed most. This included engaging with our many suppliers, contract manufacturers and distribution partners.

Cost containment and increased efficiencies
We have a strong focus on continuous improvement initiatives and savings plans to enhance production efficiencies and optimise economies of scale across the Group. Comprehensive, detailed, multi-year savings plans, covering all aspects of the operations, are progressing to plan and the improvements to the South African operations, Oss and Notre Dame de Bondeville sites are poised to deliver important future cost savings to the Group.

The cost-reduction initiatives fall into two distinct categories namely procurement and organisational design. The savings plans have a phased implementation and should be complete by the end of FY2021.

The progress made in achieving these plans across the Group Operations is monitored on a regular basis. By owning our strategically important manufacturing capital, we are able to better manage our product quality, production efficiencies and cost competitiveness to ensure responsive management of the supply chain. This, in turn, supports the maintenance of Group margins.

Additional information available online:

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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