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, MCC, MHRA, NAFDA, NDA, PIC/S, PMPB, PPB, 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, liquid and lyophilised vials for domestic and export markets.

Maximum output:

Suite A: 42 million units of eye drops; 2,9 million units of liquid vials;
Suite B: 11,75 million units of ampoules; 23,5 million units of liquid vials.

Accreditation:

ANVISA, LAsD*, MCC, PIC/S, PPB*, US FDA, WHO. (* ampoule production in Suite B
pending.).

Notre Dame de Bondeville, France

STERILE PREFILLED SYRINGE MANUFACTURING SITE

Capability:

Aseptic prefilled and terminally sterilised 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, 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:

MCC and LAsD.

Sterile facility SVP 2: high-potency suite

Capability:

Prefilled syringes for domestic and export markets.

Maximum output:

Phase 1: 110 million prefilled syringes per annum.

Accreditation:

Regulatory inspections to take place (project phase).

Bad Oldesloe, Germany

Multi-product suite

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
Primary sites

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

Our strategic objective of supplying high quality, affordable medicines and products is underpinned by our own manufacturing capabilities and the vertical integration of certain aspects of our supply chain. Our 25 manufacturing facilities present a range of production capabilities and capacities aligned with our current and future commercial objectives. These include injectables, oral solid and semi-solid dose, liquids, steriles, biologicals, APIs and nutritionals manufacturing. An overview of the Group’s strategic manufacturing capabilities is set out here.
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 and our quality and compliance standards, policies and procedures. Ongoing investment in the upgrading of our world-class manufacturing facilities as well as implementation of state of the art electronic systems ensures 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 145 million (2017: R1 484 million) with a further R2 800 million planned for 2019.

Major projects underway to enable Aspen to manufacture anaesthetics

  • Port Elizabeth - steriles
  • Notre Dame de Bondeville – blow-fill seal
  • Bad Oldesloe – creams, gels, liquids
office

PPE Capex - R'm

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

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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