Aspen's Manufacturing capabilities Primary sites Port Elizabeth, South Africa Unit 1 facility:
Capability: High-volume solids manufacturing and packing for domestic and export markets.
Capacity: 6 billion tablets. Accreditation: MCC, PIC/S, MHRA, US FDA, WHO, ANVISA, GCC, MCAZ, ICHA, PMPB, PPB, NDA, TGA, TFDA, DRU, NHRA, FMHACA and NAFDAC
Unit 2 facility:
Capability: Small to medium-volume solids manufacturing for domestic and export markets.
Capacity: 4 billion tablets. Accreditation: MCC, PIC/S, MHRA, US FDA, WHO, ANVISA, GCC, MCAZ, ICHA, PMPB, PPB, NDA, TGA, TFDA, DRU, NHRA, FMHACA and NAFDAC
Unit 3 facility:
Capability: End state packing for domestic market. Liquid manufacturing and packing until end 2014.
Capacity: 140 million packed units of tablets and capsules; 30 million packed units of liquids.
Accreditation: MCC and PIC/S
Sterile facility: multi-product and high-potency suites
Capability: Eye drops, liquid and lyophilised vials, high-potency injectables (including hormonal) for domestic and export markets.
Capacity: 42 million units of eye drops; 2,9 million units of liquid vials; 2,4Â million lyophilised vials; 30 million units of hormonal ampoules; 45 million units of hormonal vials. Accreditation: MCC, PIC/S, US FDA, WHO (only for multi-product suite), ANVISA, PPB and TGA
Notre Dame de Bondeville, France Block 3 (Etna and Stromboli* lines):
Capability: Aseptic prefilled and terminally sterilised syringe manufacturing and packing for domestic and export markets.
Capacity: 98 million syringes (Etna); 147 million syringes (Stromboli*). Accreditation: ANSM and ASN
Block 2 (Flexible manufacturing facility):
Capability: Bulk prefilled aseptic and terminally sterilised syringe manufacturing and packing for domestic and export markets.
Capacity: 37 million dilutants; 84 million prefilled syringes. Accreditation: ANSM, US FDA, PMDA, ANVISA, TRA and KFDA
Bad Oldesloe, Germany Capability: Solid dose forms, oral and topical liquids, semi-solids and blow-fill seals manufacturing and packing for export markets.
Capacity: 3,3 billion tablets; 5 429 tons of liquids; 220 tons of semi-solids,
52 million units for blow-fill seals. Accreditation: GRA, US FDA, ANVISA, PPB, PMDA, TGA, IRA, LRA and SARA
* Currently under construction.
API facilities Cape Town, South Africa
Sioux City, United States API facility:
FCC facility:
Capability: Specialist biochemical API –
Capability: Specialised API manufacturing
heparin intermediates.
for domestic and export markets. Capacity: 378 KvH. Accreditation: MCC, PIC/S, US FDA and PMDA
Capacity: Biologicals – capacity is
measured on demand – dependent on product mix. Accreditation: US FDA
Notre Dame de Bondeville, France Nadroparin facility:
Fondaparinux facility:
conversion of Heparin to Nadroparin. Capacity: 130 batches of Nadroparin Accreditation: ANSM
purification by chromatography of Fondaparinux. Capacity: 34 batches of Fondaparinux Sodium. Accreditation: ANSM, US FDA, PMDA, ANVISA, TRA and KFDA
Capability: Specialised biochemical API –
Capability: Specialised chemical API –
Oss, the Netherlands
De Geer site:
Moleneind site:
Boxtel site:
chemical APIs. Capacity: 15 000 KvH. Accreditation: IGZ, US FDA, KFDA, ANVISA and PMDA
hormonal and chemical APIs. Capacity: Dependent on product mix. Accreditation: IGZ, US FDA, KFDA, ANVISA and PMDA
Capacity: Measured on demand. Accreditation: IGZ, US FDA and PMDA
Capability: Specialised hormonal and
Capability: Specialised biochemical,
Capability: Specialised biochemical API – gonadotrophin intermediates.
Regional facilities Johannesburg, South Africa: Nutritionals
Capability: Infant milk formula and UHT infant milk liquids manufacturing and packing for domestic and export markets. Capacity: 6 800 metric tons of infant milk formula; 9 million packed units of liquid UHT. Accreditation: HACCP (SANS 10330), ISO 22000
East London, South Africa: Oral contraceptive facility
Capability: High-volume oral contraceptive manufacturing and packing for domestic market. Capacity: 1 billion tablets. Accreditation: MCC and PIC/S
East London, South Africa: Multi-product facility
Capability: Solids, semi-solids and liquid manufacturing and packing for domestic market. Capacity: 800 million tablets; 76 million packed units of liquids; 23 million packs of semi-solids. Accreditation: MCC and PIC/S
Melbourne, Australia: Noble Park
Capability: Low-volume solids. Facility expected to close in 2015. Capacity: 100 million tablets. Accreditation: TGA and PMDA
Melbourne, Australia: Dandenong
Capability: High-volume solids, liquids and semi-solids. Capacity: 3 billion tablets; 1 167 tons semi-solids; 1 721 tons liquids. Accreditation: TGA,YRA and UAERA See inside back cover for abbreviations of pharmaceutical regulatory authorities and acronyms.
Sydney, Australia: Baulkham Hills Capability: Low-volume solids. Facility expected to be closed in 2015. Capacity: 800 million tablets. Accreditation: TGA, APVMA and YRA
Vitória, Brazil
Capability: Small to medium-volume solids and semi-solids. Capacity: 650 million tablets; 20 million units of semi-solids. Accreditation: ANVISA and GMP Certificate
Toluca, Mexico
Capability: Small to medium-volume solids. Capacity: 38 million tablets; 50 million capsules. Accreditation: COFEPRIS
Vallejo, Mexico
Capability: Infant milk formula manufactured and packed for the domestic and export markets. Capacity: 20 000 metric tons of infant milk formula. Accreditation: FSSC 22000
Dar es Salaam, Tanzania: Shelys
Capability: Medium-volume solids and liquids, small to medium-volume semi-solids. Capacity: 1,2 billion tablets; 10 tons of semi-solids; 1 500 kℓ of liquids. Accreditation: TFDA**, PPB*, GFDB, PMPD, PRA, MOH – DRC, MOH – IC, NDA, DACA, FMHACA and PIC/S
Nairobi, Kenya: Beta
Capability: Small to medium-volume solids, liquids and fast-moving consumer goods. Capacity: 500 million tablets; 488 kℓ of liquid. Accreditation: PPB*, NDA**, PMPB*, TFDA, MCAZ, MOH – DRC and PRA * Routine audit applied for. ** Site audited – GMP Certificate awaited.