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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