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Manufacturing Capabilities

GQEBERHA, 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, ISO 45001, 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, ISO45001, PMPB, PPB – Kenya, SAHPRA, SAUDI FDA, TGA, UNDA, 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, ISO 45001, SAHPRA.

UNIT 4 FACILITY

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

>Maximum output:
950 million tablets (hormonal); 395 million tablets (high potency).

Accreditation: EMA, ISO 14001, LAsD, ISO 45001, SAHPRA, TGA, Turkey MoH, US FDA.

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 30 million units of liquid vials.

Accreditation:
Suite A: ISO 14001, ISO45001, 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 sterilisation 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. 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: GRA, IRA, ISO 14001, ISO 45001, ISO 50001, LRA, PPB – Kenya, PMDA, TGA, US FDA.

MELBOURNE, AUSTRALIA

DANDENONG

Capability: High-volume solids, liquids and semi-solids.
Maximum output: 3 billion tablets; 90 million sachets; 12 tonnes semi-solids; 2 200 tonnes liquids.
Accreditation: ISO 14001, ISO 45001, TGA.

VITÓRIA, BRAZIL
Capability: Small to medium-volume solids, liquids and semi-solids.
Maximum output: Solids: 141,2 million tablets and capsules/year.
Semi-solids: 4,0 million units/year.
Liquids: 4,9 million bottles/year.
Sealing: 22,9 million units/year.
Accreditation: ANVISA, GMP, ISO 14001, ISO 45001.
ACCRA, GHANA
Capability: Small- to medium-volume liquids.
Maximum output: 567 kℓ of liquids.
Accreditation: GFDA.
HYDERABAD, INDIA
Further to the June 2021 fire accident at Alphamed site, reinstatement of manufacturing and packing capabilities as per below completed, and the facility is ready for operations.
Capability: Small to medium-volume solid oral dosage forms manufacturing for export markets.
Maximum output: 020 million tablets; 46 million effervescent tablets; 300 million capsules; 50 tonnes of pellets; 60 million powder-filled sachets.
Accreditation: GMP inspections scheduled during September to December 2022.
NAIROBI, KENYA
Capability: Small to medium-volume solids, liquids and fast-moving consumer goods.
Maximum output: 750 million tablets; 600kℓ of liquid.
Accreditation: AIRP-Cl, EFDA, GFDA, ISO14001, ISO 45001, MCAZ, MoH-DRC, NAFDAC, PMRA-Malawi, PPB – Kenya, TMDA, UNDA, ZAMRA.
EAST LONDON, SOUTH AFRICA

Oral contraceptive facility

Capability: High-volume oral contraceptive manufacturing and packing for domestic market.
Maximum output: 1 billion tablets.
Accreditation: ISO 14001, OHSAS 18001, SAHPRA.

Multi-product facility

Capability: Solids, semi-solids and liquid manufacturing and packing for domestic market.
Maximum output: 560 million tablets; 32 million packs of semi solids; 160 million packed units of liquids.
Accreditation: ISO 14001, ISO 45001, SAHPRA.

DAR ES SALAAM, TANZANIA
Capability: Small-to medium-volume semi-solids, large-volume solids and liquids.
Maximum output: 1 billion tablets; 60 million capsules; 15 tonnes of semi-solids; 1 500kℓ of liquids; 8 million sachets.
Accreditation: AIRP-Cl, EFDA, MoH – DRC, NAFDAC, PMRA-Malawi, PPB – Kenya, TMDA, ZAMRA.

Manufacturing operational overview

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 provide a range of production capabilities and capacities, assisting us in the achievement of our current and future commercial objectives. These include steriles, oral solid, semi-solid, liquids, biologicals, vaccines and API manufacturing. Our niche and complex production capabilities provide a strategic advantage in an increasingly commoditised environment. Our sterile capacity and capability is a strategic advantage when considering the increased demand for vaccines and other steriles, including biological products.

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, support our ability to supply quality products, ensure ongoing compliance with GMP and create 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 R1 963 million (2021: R2 045 million), with a further R2 300 million planned for FY2023 driven by the additional sterile manufacturing capacity to be used for vaccines and other steriles including biological products. The level of capital expenditure on these strategic projects is expected to reduce from FY2025.

Property, plant and equipment capital expenditure (R’million)*

Following the transactions with AstraZeneca AB and AstraZeneca UK, and GlaxoSmithKline Plc, which resulted in the acquisition of our Anaesthetics portfolio, we are transitioning supply from their manufacturing sites to our own sites and supply chain network, providing us with a strategic opportunity to pursue synergies. Significant capital projects are in progress at the Gqeberha, Notre Dame de Bondeville and Bad Oldesloe sites in order to effect these manufacturing transfers. First commercial production of these products at the Gqeberha and Bad Oldesloe sites has commenced, with production and subsequent commercialisation planned for FY2024 at the Notre Dame de Bondeville site.

Oral solid dose manufacturing

We remain focused on increasing the complex manufacturing capability at the Gqeberha site. This site has the ability to provide flexible high-volume manufacturing and packing capabilities for a variety of oral solids doses to several countries through the different regulatory approvals held by the respective units. 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:

Gqeberha, South Africa

  • The Manufacturing Execution System implementation is progressing on schedule in facilities that require implementation prior to SAP go-live which is planned for March 2023.
  • The implementation of the Laboratory Information System is on schedule for completion in all South African Operations laboratories by December 2022.
  • The organisational redesign in the Quality Control laboratories is 90% completed and is yielding the required results. Further optimisation is performed as and when required.
  • There is increased focus on initiatives to enhance competence at all levels across the site to ensure sustainable performance in the long term. Projects aimed at self-sufficiency in terms of water are completed. Projects aimed at self-sustainability in electricity supply have progressed to the point of readiness to conclude Power Purchase Agreements within the first quarter of the 2023 financial year with construction completed by January 2024. In the interim sufficient back-up power supply is available on a rental contract.

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 almost complete. Two lines are already producing product for market supply and the process validation on another line is nearly completed.
  • The project to install a new blow-fill seal line has been initiated. Construction of the building and the installation of all production machines have been completed and qualification has started. Remaining activities will be completed by early 2023. This line will provide competitive advantages and a production capacity of 120 million sterile single-dose poly ampoules per annum.

Sterile manufacturing

Our facilities at the Gqeberha 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:

Gqeberha, South Africa

  • Activities to introduce Anaesthetics production have commenced, a significant step in the evolution of this site. Phases 1 to 3 of the new infrastructure build component are complete and equipment is being installed and commissioned. The equipment that has already been installed is undergoing site acceptance testing. The first commercial batches were manufactured in March 2021. Validation batches for the balance of the products are underway, with completion of validation estimated for January 2023. 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 SKUs being added to the existing portfolio during the ramp-up phase over the next four years.
  • The facility received a vaccine manufacturing licence from the South African Health Products Regulatory Authority in February 2021 and dedicated production of the Johnson & Johnson COVID-19 vaccine has been ongoing since first commercialisation in March 2021. Plans for expansion of the facility’s vaccine manufacturing as well as lyophilization capacity has been approved and procurement of equipment is at an advanced stage. Construction of the required civil infrastructure is due to commence in FY2023. This includes the required support services such as packaging, cold storage and laboratories.

Notre Dame de Bondeville, France

  • The new suite to manufacture anaesthetic dosage forms comprising polybags and poly ampoules is complete. Validation has started on the first line and the completion of the validation for the third line is targeted for the end of 2023.
  • The new suite to manufacture anaesthetic dosage forms comprising polybags and poly ampoules is complete. Validation has started on the first line and the completion of the validation for the third line is targeted for the end of 2023.
  • The technical transfer for a further 80 000 prefilled syringes has commenced and commercial production is expected to commence in FY2024
  • Installation of a new automatic visual inspection line for prefilled syringes is progressing with qualification and validation to commence commercial production in the third quarter FY2023.
  • New autoclave investment for terminal sterilisation capabilities has been initiated to handle the growth of the diluent business at this site. Autoclaves will be installed and commissioned in FY2023.
  • An extension of the warehouse with a cold chamber (approximately 1500 pallets) has been initiated to deal with the special requirements of vaccines storage. These works will be completed in FY2024.

API manufacturing

Our API network comprises seven owned sites; 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 Labs 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 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

  • At the De Geer site, an automation upgrade is being prepared for all vessels to further reduce manual operator tasks.
  • The upgrade of the process automation system in all the Moleneind site installations has been completed and preparative work for the Manufacturing Execution System implementation (both at the Moleneind and De Geer sites) is ongoing.
  • At Moleneind, a new fire extinguishing installation has been installed in one of the production buildings, while three more buildings are in preparation. This mitigates business risk and reduces the size of the mandatory company fire brigade.
  • A new storage location for stability samples and reference standards has been realised utilising existing space in one of the laboratory buildings.
  • At the Moleneind site, several older facilities were demolished and obsolete installations removed.
  • In the Biochem division, an investment in filter drier capacity provides support for a second-generation heparin process
  • At Moleneind, the partial automation of several vessels is planned to eliminate the possibility of a spill.
  • An active footprint reduction programme aimed at concentrating activities in core buildings is ongoing at the different sites in the Netherlands as part of the transformation plan.

FCC in Cape Town, South Africa

  • Additional steps have been taken to achieve further integration over the chemical supply chain. Additional production steps of intermediates in the rocuronium bromide synthesis have now been transferred from Oss to FCC as synergies across these two sites begin to be harnessed.
  • FCC has been onboarded on the Oss SAP infrastructure. This was a major IT investment with impact on FCC’s ways of working, but constituted a substantial step towards a further integrated API network/supply chain.
  • The full-scale commercial manufacture of API was initiated in the newly validated high containment/high efficiency production block C2, in support of backward integration projects.
  • The final validation of the recently installed high containment milling and micronising process centre was effected.
  • The development and optimisation of an anaesthetic API, which will also support backward integration into the Aspen portfolio of products, was concluded.
  • A new water treatment plant for the use of alternate underground water supply during times of constrained local municipal supply was commissioned and validated.
  • A new hazardous aqueous waste treatment plant and a solvent recovery unit are being finalised, with both being installed and commissioned in the current financial year, resulting in significant long-term cost savings.
  • The upgrade and expansion of fire prevention and control systems in line with regulatory requirements has continued.

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.

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, the Oss and the 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: procurement and organisational design. The savings plans have a phased implementation and should be complete by the end of the next calendar year. In addition to the procurement and organisational changes, structural process efficiency initiatives are ongoing and will have both an economical and an ecological improvement, supporting the Group’s sustainability goals.

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.

PRIMARY SITES

  • Located in Gqeberha, South Africa; Notre Dame de Bondeville, France and Bad Oldesloe, Germany
  • Capabilities for domestic and export markets include steriles, eye drops, blow-fill seal ampoules, vials and cartridges, lyophilized vials, polybag manufacturing,
    solids, semi-solids, liquids and end state packing
  • Site-specific centres of production excellence
  • Manufacturing capabilities enable control and access over niche pipeline opportunities
  • Large-scale capabilities leading to cost of goods sold
  • Ensure uniform high quality globally
  • Specialist capabilities and skills
  • Provide overall strategic advantage for the Group
  • Globally accredited

Highlights of Aspen’s anaesthetics manufacturing line in Gqeberha, South Africa

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Aspen's Vaccine Production
in Gqeberha, South Africa

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Aspen's Sterile Facility in Gqebhera, South Africa

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API FACILITIES

  • Located in Cape Town, South Africa; Notre Dame de Bondeville, France; Sioux City, United States of America and Oss, The Netherlands
  • Capabilities for domestic and export markets include specialised biochemical, hormonal and chemical APIs, biochemical API conversion, chemical API purification, peptides, steroids/hormones, high potency products and other chemicals
  • Biological capabilities including heparin where Aspen has become a significant global player
  • Provides vertical integration advantage for the Group
  • Globally accredited

An overview of Aspen's API Facilities

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Aspen Notre Dame de Bondeville

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REGIONAL FACILITIES

  • Located in Melbourne, Australia; Vitória, Brazil; Accra, Ghana; Hyderabad, India; Nairobi, Kenya; East London, South Africa
    and Dar es Salaam, Tanzania
  • Capabilities include solids, semi-solids, liquids and fast moving consumer goods for local and limited export markets
  • Supply local and regional needs across diverse territories
  • Globally accredited

 

Aspen Head Office
Umhlanga, Durban - South Africa

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