MANUFACTURING CAPABILITIES
Primary sites
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:
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.
Capability:
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.
Capacity:
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, BFARM*, MCC, PIC/S, PPB*, US FDA, WHO (pre-qualification) (* pending).
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:
85 million syringes (Etna line);
130 million syringes (Stromboli 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.
Capacity:
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 high potency solids manufacturing and packaging for the domestic and export markets.
Capacity:
3,2 billion tablets (hormonal);
395 million tablets (potency).
Accreditation:
Facility has been commissioned. Initial trial batches are currently in process.
The first regulatory body inspections will start in the first quarter of 2017.
Sterile facility SVP 2: high-potency suite
Capability:
Prefilled syringes for domestic and export markets.
Capacity:
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 seals,
manufacturing and packing for domestic and export markets.
Capacity:
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
Regional facilities