Aspen 2014 Manufacturing Capabilities

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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.


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