Manufacturing Expertise

Aspen – Africa’s largest pharmaceutical manufacturer continues to invest in people, equipment and infrastructure, and, coupled with continuous improvement projects and a strong management team, ensures that the South African manufacturing facilities are well positioned to supply high quality, cost effective products to the domestic and selected international markets.

Aspen has 26 pharmaceutical manufacturing facilities at 18 pharmaceutical manufacturing sites on 6 continents.  Aspen has production capabilities for a wide variety of product types including tablets, capsules, steriles, injectables, penicillins, penems, infant milk formulations, liquids and creams.

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Aspen’s flagship manufacturing site in Port Elizabeth, South Africa.

The Group’s extensive basket includes branded, generic, over-the-counter (OTC), self medication, personal care and infant nutritional products.

Aspen has an outstanding generic pipeline. These products are developed under the direction of highly skilled scientists employed by Aspen and in collaboration with other global pharmaceutical companies and research facilities.

Aspen’s primary manufacturing site based in Port Elizabeth is the largest on the continent and employs significant expertise in its manufacturing facilities. This long established site is the leading producer of tablets and capsules in South Africa. This site is comprised of three facilities namely the Oral Solid Dose (OSD) Facility, the General Facility and the Sterile Facility.

Aspen’s state-of-the-art Unit 1 Facility is a high volume manufacturer of tablets and capsules including antiretrovirals (ARVs). Aspen became the world’s first pharmaceutical manufacturer to be granted US Food and Drug Administration (FDA) approval to manufacture combination therapy generic ARVs in a co-packed form.

This world first recognises the scientific and technical capabilities of South Africa and Aspen, as well as the company’s manufacturing quality and management strength. The approval qualifies Aspen as the first generic supplier under the United States President’s Emergency Plan for Aids Relief programme to which funding of US $15 billion was committed in 2003. The OSD Facility has been inspected and accredited by the MCC, the US FDA, the UK MHRA, WHO, Australian TGA and numerous African states.

Aspen’s heritage General Facility is presently undergoing several upgrade projects. This capital investment is being incurred in order to increase production capabilities and to provide ongoing compliance with Pharmaceutical Inspection Convention standards. The phased upgrade of the General Facility started in early 2007 and is due for completion in the 2009 calendar year.

The General Facility manufactures tablets, capsules, liquids, ointments, creams, suppositories and powders and is accredited by the MCC.

Aspen’s objectives of providing world class local production capabilities has been enhanced with the construction of a Sterile Facility with production capabilities in sterile injectables, eye drops and lyophilized freeze-dried vials. Inspections by the MCC and other international regulatory authorities including the US FDA, are scheduled to take place within the next year. Commercial production is anticipated to commence during the second half of the 2009 financial year.

Aspen also has extensive manufacturing capability and capacity through its MCC accredited East London-based Manufacturing Site which includes a Multi-Purpose Facility and an Oral Contraceptive Facility. The Multi-Purpose Facility has production capabilities in tablets, capsules, ointments, lotions, liquids, tinctures, self medication and personal care products. The Oral Contraceptives Facility is a specialist facility for the manufactures of oral contraceptives.

 

Aspen East London

Aspen East London’s Manufacturing Site comprise Multi-Purpose and Oral Contraceptive Facilities.

Aspen’s Clayville-based Nutritional Formulations Facility is a specialist manufacturer of value-added infant nutritional products which comply with the highest international manufacturing standards.

Aspen Nutritionals supplies a range of infant milk formulations to the South African market and exports into parts of Africa.

Aspen Nutritionals supplies a range of infant milk formulations to the South African market and exports into parts of Africa.

An additional strength for Aspen lies in its vertical integration into the manufacture of APIs, the key raw materials required in the manufacture of finished dosage form pharmaceuticals including ARVs.

This is enabled through Aspen’s joint venture companies in Cape Town, South Africa and Hyderabad, India which are co-owned by Matrix Laboratories of India. Cape Town-based Fine Chemicals Corporation (FCC) is an FDA approved facility specializing in post-patent APIs for sale into South Africa and various international markets. Hyderabad based Astrix Laboratories specializes in the manufacture of ARV APIs, supplying to its largest customer, Aspen, as well as to other manufacturers of ARVs. Agreements have however recently been reached for Aspen to acquire the remaining 50% of FCC and to dispose of Astrix subject to the fulfillment of certain conditions.

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Aspen’s Regulatory Affairs

Aspen’s Regulatory Affairs Divisions ensures that dossiers are timeously submitted for registration to the MCC and other regulation bodies, in order to realize Aspen’s strong pipeline. Regulatory capability has been developed to manage an efficient registration process for both the domestic and international markets.

An electronic document management system is being implemented to enhance document compliance management and quality process management across the Group.

 

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South African Medicines Control Council

 

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US Food & Drug Administration

 

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MHRA – Medicine & Healthcare Products Regulatory Authority

 

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WHO – World Health Organisation