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.