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Our manufacturing capabilities

Primary sites

Regional facilities


  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 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, 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: SAHPRA

UNIT 4 FACILITY

Capability: Hormonal and high-potency 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 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.

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.

  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.

  BAD OLDESLOE, GERMANY

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.

  ACCRA, GHANA

Capability: Small to medium-volume liquids.
Maximum output: 567 kℓ of liquids
Accreditation: GFDA.

  DAR ES SALAAM, TANZANIA

Capability: Small to medium volume semisolids, large volume solids and liquids.
Maximum output: 1,0 billion tablets; 60 million capsules; 15 tonnes of semi-solids; 1 500 kℓ of liquids; 8 million sachets.
Accreditation: PPB, TMDA, PMPB, ZAMRA, MoH – DRC, NAFDAC, DPML-CI, EFDA.

  EAST LONDON, SOUTH AFRICA

ORAL CONTRACEPTIVE FACILITY
Capability: High-volume oral contraceptive manufacturing and packing for domestic market.
Maximum output: 1 billion tablets.
Accreditation: Last audit conducted by SAHPRA in 2009

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: SAHPRA.

We manufacture a
wide variety of product types

including injectables, oral solid dose, liquids, semi-solids, steriles, biologicals and APIs.

Abbreviations of pharmaceutical regulatory authorities and acronyms.


 

 Regional facilities

 API facilities


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

  MELBOURNE, AUSTRALIA

Capability: High-volume solids, liquids and semi-solids.
Maximum output: 3 billion tablets; 90 million sachets; 1 167 tonnes semi-solids; 1 721 tonnes liquids.
Accreditation: TGA, ISO 14001, OSHAS 18001.

  NAIROBI, KENYA

Capability: Small to medium-volume solids, liquids and fast-moving consumer goods.
Maximum output: 750 million tablets; 600 kℓ of liquid.
Accreditation: PPB, TMDA, UNDA, PMPB, ZAMRA, MoH -DRC, EFDA, NAFDAC, MCAZ, GFDA.

  VITÓRIA, BRAZIL

Capability: Small to medium-volume solids, liquids and semi-solids.
Maximum output: 10,5 million sealing; 162 million tablets and capsules; 675 000 bottles of liquids or 40 kℓ; 380 000 packs of semi-solids or 3,8 tonnes.
Accreditation: ANVISA, GMP, ISO 14001, OHSAS 18001.

23 manufacturing
facilities at 15sites
on 6 continents
  CAPE TOWN, SOUTH AFRICA

Capability: Specialised API and high potency manufacturing for domestic and export markets.
Maximum output: 46 000 kg
Accreditation: EDQM, PMDA, SAHPRA, US FDA.

  NOTRE DAME DE BONDEVILLE, FRANCE

NANDROPARIN & CERTOPARIN FACILITY
Nadroparin

Capability: Specialised biochemical API – conversion of heparin to nadroparin.
Maximum output: 200 batches of nadroparin.
Accreditation: ANSM, DQS.
Certoparin
Capability: Specialised biochemical API – conversion of heparin to certoparin.
Maximum output: 45 batches of certoparin.
Accreditation: Regulatory submission to take place.

FONDAPARINUX FACILITY
Capability: Specialised chemical API – purification by chromatography of fondaparinux.
Maximum output: 34 batches of fondaparinux sodium.
Accreditation: ANSM, ANVISA, DQS, KFDA, PMDA, TRA, US FDA.

  SIOUX CITY, USA

Capability: Specialist biochemical API – heparin intermediates.
Maximum output: Biologicals – capacity is measured on demand – dependent on product mix.
Accreditation: Re-registration for US FDA.

  OSS, THE NETHERLANDS

DE GEER SITE

Capability: Specialised hormonal and chemical APIs: wet chemical multipurpose capability, final powder handling (milling/sieving) and solvent recovery by distillation.

Maximum output:

Installed reactor capacity: 114 m3 with reactor size between 2 m3 and 10 m3 beside bulk tank storage capability.

Accreditation: ANVISA, EMA, ISO 14001, KFDA, OHSAS 18001, PMDA, Russia MoIT, US FDA.

MOLENEIND SITE

Capability: Specialised biochemical, hormonal and chemical APIs. Dedicated biochemical reactors, multipurpose chemical reactors and dedicated solvent recovery unit.

Maximum output: Installed chemical reactor capacity (small molecule API + peptides): 59 m3;
Biochem reactor capacity: 245 m3 beside multiple storage capacity.

Accreditation: ANVISA, EMA, ISO 14001, KFDA, OHSAS 18001, PMDA, Russia MoIT, US FDA.

BOXTEL SITE

Capability: Specialised biochemical API – gonadotrophin intermediates and virus filtered API.

Maximum output: Measured on demand.

Accreditation: EMA, ISO 14001, OHSAS 18001, PMDA, US FDA.