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

API FACILITIES

Cape Town, South Africa

FCC API facility

Capability:

Specialised API manufacturing for domestic and export markets.

Capacity:

46 000kg

Accreditation:

EDQM, MCC, PIC/S, PMDA, US FDA.

Notre Dame de Bondeville, France

Nadroparin facility

Capability:

Specialised biochemical API – conversion of heparin to nadroparin.

Capacity:

200 batches of nadroparin.

Accreditation:

ANSM, DQS.

Fondaparinux facility

Capability:

Specialised chemical API – purification by chromatography of Fondaparinux.

Capacity:

34 batches of Fondaparinux sodium.

Accreditation:

ANSM, ANVISA, DQS, KFDA, PMDA, TRA, US FDA.

Sioux City, USA

Sioux City facility

Capability:

Specialist biochemical API – heparin intermediates.

Capacity:

Biologicals – capacity is measured on demand – dependent on product mix.

Accreditation:

US FDA.

Oss, the Netherlands

De Geer site

Capability:

Specialised hormonal and chemical APIs.

Capacity:

150 000KvH.

Accreditation:

ANVISA, IGZ, KFDA, PMDA, US FDA.

Moleneind site

Capability:

Specialised biochemical, hormonal and chemical APIs.

Capacity:

Dependent on product mix.

Accreditation:

ANVISA, IGZ, KFDA, PMDA, US FDA.

Regional facilities

REGIONAL FACILITIES

Johannesburg, South Africa

Capability:

Infant nutritionals and UHT infant milk liquids manufacturing and packing
for domestic and export markets.

Capacity:

6 800 metric tonnes of infant nutritionals;
9 million packed units of liquid UHT.

Accreditation:

ISO 22000.

 

East London, South Africa

Capability:

High-volume oral contraceptive manufacturing and packing for domestic market.
Solids, semi-solids and liquid manufacturing and packing for domestic market.

Capacity:

1 billion tablets;
800 million tablets;
64 million packed units of liquids;
21 million packs of semi-solids.

Accreditation:

MCC and PIC/S.

 

Melbourne, Australia

Capability:

High-volume solids, liquids and semi-solids.

Capacity:

3 billion tablets;
90 million sachets;
1 167 tonnes semi-solids;
1 721 tonnes liquids.

Accreditation:

IOS 14001, OHSAS 18001, TGA, UAERA and YRA.

 

Auckland, New Zealand

Capability:

Infant nutritionals, dairy powder blending and packing for domestic and export markets.

Capacity:

24 000 tonnes of 900g cans (27 million cans);
70 million single serve sachets.

Accreditation:

China GMP, CNCA, FSSC 22000, HACCP, Halaal, Organic, NZ RMP.

 

Vitória, Brazil

Capability:

Small to medium-volume solids and liquids.

Capacity:

220 million tablets and capsules;
96kℓ of liquids.

Accreditation:

ANVISA, GMP, ISO 14001, OHSAS 18001.

Toluca, Mexico

Capability:

Small to medium-volume solids.

Capacity:

38 million tablets;
50 million capsules.

Accreditation:

COFEPRIS.

 

Vallejo, Mexico

Capability:

Infant nutritionals manufactured and packed for the domestic and export markets.
Small to medium-volume solids, semi-solids and liquids.

Capacity:

20 000 tonnes of infant nutritionals;
225 million tablets and capsules;
1 300 tonnes semi-solids;
2 000 tonnes liquids.

Accreditation:

COFEPRIS, FSSC 22000, ISO 9001, ISO 14001, OHSAS 18001.

 

Dar es Salaam, Tanzania

Capability:

Small to medium-volume semi-solids, large-volume solids and liquids.

Capacity:

1,2 billion tablets;
15 tonnes of semi-solids;
1 500kℓ of liquids.

Accreditation:

*To be re-inspected
**Routine renewal inspection applied for

 

Nairobi, Kenya

Capability:

Small to medium-volume solids, liquids and fast-moving consumer goods.

Capacity:

500 million tablets;
488kℓ of liquid.

Accreditation:

FMHACA, MCAZ, MOH – DRC, NDA, PMPB, PPB, PRA, TFDA, ZAMRA.

 

Accra, Ghana

Capability:

Small to medium-volume liquids.

Capacity:

567kℓ of liquids.

Accreditation:

GFDB.