Creating value through our capitals

Manufacturing capabilities

  PORT ELIZABETH, SOUTH AFRICA
 

UNIT 1 FACILITY

Capability: High-volume solids manufacturing and packing for domestic and export markets.

Maximum output:

6 billion tablets.

Accreditation: ANVISA, EMA, HPRA, ISO 14001, NDA, OHSAS 18001, PMPB, PPB, SAHPRA, SAUDI FDA, TGA, US FDA, WHO.

UNIT 2 FACILITY

Capability: Small to medium-volume solids manufacturing for domestic and export markets.

Maximum output:

4 billion tablets.

Accreditation: ANVISA, EMA, HPRA, ISO 14001, NDA, OHSAS 18001, PMPB, PPB, SAHPRA, SAUDI FDA, TGA, US FDA, WHO.

UNIT 3 FACILITY

Capability: End state packing for domestic market.

Maximum output:

140 million packed units of tablets and capsules.

Accreditation: ISO 14001, OHSAS 18001, SAHPRA.

UNIT 4 FACILITY

Capability: Hormonal and high-potency solids manufacturing and packaging for the domestic and export markets.

Maximum output:

950 million tablets (hormonal); 395 million tablets (potency).

Accreditation: EMA, ISO 14001, LAsD, OHSAS 18001, SAHPRA, TGA, Turkey MoH, US FDA.

STERILE FACILITY SVP 1: MULTI-PRODUCT SUITES A AND B

Capability: Eye drops, ampoules, vials; aseptic and terminal sterilization capability for domestic and export markets.

Maximum output:

Suite A:

Up to 42 million units of eye drops;

Suite B:

Up to 25 million units of ampoules;

Up to 12 million units of liquid vials.

Accreditation:

Suite A: ISO 14001, OHSAS 18001, SAHPRA, TGA, US FDA, WHO.

Suite B: EMA, ISO 14001, LAsD, OHSAS 18001, SAHPRA, TGA, US FDA, WHO.

STERILE FACILITY SVP 2: HIGH-POTENCY SUITE

(Commercial production FY2021)

Capability: Liquid ampoules, vials and cartridges; emulsion ampoules, vials and cartridges; lyophilized vials; aseptic and terminal sterilization capability for domestic and export markets.

Maximum output:

Suite C, D and E:

90 million units (container size and bulk batch dependent).

Accreditation: Regulatory inspections pending (project phase).

LAsD tentatively planned, SAHPRA (all suites) and TGA (suite C).

  NOTRE DAME DE BONDEVILLE, FRANCE
 

STERILE PREFILLED SYRINGE MANUFACTURING SITE

Capability: Aseptic and terminally sterilised prefilled syringe manufacturing and packing for domestic and export markets.

Maximum output:

85 million syringes (Etna line); 130 million syringes (Stromboli line); 180 million syringes (Vesuve line).

Accreditation: ANSM, ANVISA, ASN, HPB, ISO 14001, ISO 45001, ISO 50001, PMDA, US FDA.

NEW ANAESTHETICS FACILITY UNDER CONSTRUCTION

(Commercial production FY2023)

Capability: Aseptic and terminally sterilised blow-fill seal ampoule and polybag manufacturing and packing for domestic and export markets.

  BAD OLDESLOE, GERMANY
 

MULTI-DOSE FORM SITE

(Ramp up of additional commercial production is expected over the next two years and capacity will be included in maximum output below as and when it becomes available)

Capability: Solid dose forms, oral and topical liquids, semi-solids and blow-fill seal, manufacturing and packing for domestic and export markets.

Maximum output:

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, ISO 14001, ISO 45001, ISO 50001, LRA, PPB, PMDA, TGA, US FDA.

  MELBOURNE, AUSTRALIA
 

DANDENONG

Capability: High-volume solids, liquids and semi-solids.

Maximum output: 3 billion tablets; 90 million sachets; 1 167 tonnes semi-solids; 2 200 tonnes liquids.

Accreditation: ISO 14001, OSHAS 18001, TGA.

  VITÓRIA, BRAZIL
 

Capability: Small to medium-volume solids, liquids and semi-solids.

Maximum output: 10,5 Million sealing; 195 million tablets and capsules; 1,5 million bottles of liquids; 912 000 packs of semi-solids.

Accreditation: ANVISA, GMP, ISO 14001, OHSAS 18001.

  ACCRA, GHANA
 

Capability: Small to medium-volume liquids.

Maximum output: 567 kℓ of liquids.

Accreditation: GFDA.

  HYDERABAD, INDIA
 

Capability: Small to medium-volume solids manufacturing for export markets.

Maximum output: 700 million tablets; 30 million effervescent tablets; 120 million capsules; 60 tonnes of pellets; 25 million powder filled sachets.

Accreditation: ANVISA, DCA, ISO 17025, ISO 9001, SAHPRA.

We manufacture a wide variety of product types including steriles, oral solid dose, liquids, semi-solids, biologicals and APIs.

The maximum output is an estimate based on a number of assumptions regarding product mix and complexity, batch size, type and size of products and overall equipment effectiveness.



  NAIROBI, KENYA
 

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

Maximum output: 750 million tablets; 600 kℓ of liquid.

Accreditation: EFDA, GFDA, MoH -DRC, NAFDAC, MCAZ, PMPB, PPB, TMDA, UNDA, ZAMRA.

  EAST LONDON, SOUTH AFRICA
 

Oral contraceptive facility

Capability: High-volume oral contraceptive manufacturing and packing for domestic market.

Maximum output: 1 billion tablets.

Accreditation: ISO 14001, OHSAS 18001, SAHPRA.


Multi-product facility

Capability: Solids, semi-solids and liquid manufacturing and packing for domestic market.

Maximum output: 560 million tablets; 32 million packs of semi solids; 160 million packed units of liquids.

Accreditation: ISO 14001, OHSAS 18001, SAHPRA.

  DAR ES SALAAM, TANZANIA
 

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

Maximum output: 1,0 billion tablets; 60 million capsules; 15 tonnes of semi-solids; 1 500 kℓ of liquids; 8 million sachets.

Accreditation: DPML-CI, EFDA, MoH - DRC, NAFDAC, PMPB, PPB, TMDA, ZAMRA.

23 manufacturing facilities at 15 sites on 6 continents.

Abbreviations of pharmaceutical regulatory authorities and acronyms

  CAPE TOWN, SOUTH AFRICA
 

Capability: Specialised API and high potency manufacturing for domestic and export markets. Large diversity of reactor MOC and sizing ranging from 20l pilot lab to 6000 l commercial scale. OEL 1ug / m3 - 50ng / m3.

Maximum output:

Commercial volume batch sizes ranging from 4kg to 500kg.

Output of 46 000kg per annum.

Accreditation: EDQM, ISO 14001, ISO 45001, PMDA, SAHPRA, US FDA.

  NOTRE DAME DE BONDEVILLE, FRANCE
 

NANDROPARIN & CERTOPARIN FACILITY

Nadroparin

Capability: Specialised biochemical API - conversion of heparin to nadroparin.

Maximum output:

200 batches of nadroparin.

Accreditation: ANSM, ISO 14001, ISO 45001, ISO 50001.

Certoparin

Capability: Specialised biochemical API - conversion of heparin to certoparin.

Maximum output:

45 batches of certoparin.

Accreditation: Bfarm, ISO 14001, ISO 45001, ISO 50001.


FONDAPARINUX FACILITY

Capability: Specialised chemical API - purification by chromatography of fondaparinux.

Maximum output:

34 batches of fondaparinux sodium.

Accreditation: ANSM, ANVISA, ISO 14001, ISO 45001, ISO 50001, KFDA, PMDA, TRA, US FDA.

  SIOUX CITY, USA
 

Capability: Specialist biochemical API - heparin intermediates.

Maximum output:

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

Accreditation: Re-registration for US FDA.

  OSS, THE NETHERLANDS
 

DE GEER SITE

Capability: Specialised hormonal and chemical APIs: wet chemical multipurpose capability, final powder handling (milling/sieving) and solvent recovery by distillation.

Maximum output:

Installed reactor capacity: 114m3 with reactor size between 2m3 and 10m3 beside bulk tank storage capability.

Accreditation: ANVISA, EMA, ISO 14001, ISO 45001, KFDA, PMDA, Russia MoIT, US FDA.


MOLENEIND SITE

Capability: Specialised biochemical, hormonal and chemical APIs. Dedicated biochemical reactors, multipurpose chemical reactors and dedicated solvent recovery unit.

Maximum output:

Installed chemical reactor capacity (small molecule API + peptides): 59m3.

Biochem reactor capacity: 245m3 beside multiple storage capacity.

Accreditation: ANVISA, EMA, ISO 14001, ISO 45001, KFDA, PMDA, Russia MoIT, US FDA.


BOXTEL SITE

Capability: Specialised biochemical API - gonadotrophin intermediates and virus filtered API.

Maximum output:

Measured on demand.

Accreditation: EMA, ISO 14001, ISO 45001, PMDA, US FDA.