The pharmaceutical industry is one of constant change, strict regulatory rules and mergers and acquisitions. Within Africa, the largest pharmaceutical manufacturer is Aspen Group, a company with a worldwide reach and its fair share of acquisitions.
According to the Aspen Nutritionals website, Aspen has an extensive global presence and is represented in 47 countries including South Africa, Australia, Hong Kong, Malaysia, Philippines, Taiwan, Japan, Kenya, Nigeria, Tanzania, Uganda, Ireland, United Arab Emirates, Germany, France, the Netherlands, Mauritius, Brazil, Mexico, Venezuela and the United States.
Since 2013 the Group has made further acquisitions which have further extended its emerging market presence to the Commonwealth of Independent States (“CIS”), comprising Russia and the former Soviet Republics as well as to Central and Eastern Europe.
Aspen Nutritionals in the meantime, supplies parents and Healthcare Professionals with quality nutritional products that are scientifically manufactured in compliance with the highest international standards.
Located in Clayville, Gauteng, the company scientifically manufactures nutritional products that comply with a vast range of global regulatory protocols. Production takes place in accordance with Current Good Manufacturing Practices (CGMP) and all processes are HACCP certified through Food Safety Services International (FSSI) which is accredited with the South African National Accreditation System (SANAS).
The process is extremely complex and the company website reports that up to 60 individual physical, sensorial, chemical and microbiological tests are performed on every single batch number of nutritional products to ensure that the food safety of its customers is protected 100 per cent.
“Additionally a complete stability programme is in place to ensure continued suitability, safety and efficacy of all nutritional products up to the shelf life of each product,” the website states.
As already intimated, there is a mountain of regulatory compliance that has to be attained in order to succeed in this area. The Aspect Nutritionals website describes just how these rules are met:
“The ingredients used are of a suitable food grade and comply with the declared characteristics and requirements defined in South African food legislation.
“The additives, if used, fully conform to the requirements prescribed in the South African food legislation.
“Aspen Nutritionals’ manufacturing facility is HACCP and ISO 22000 registered with FSSI, a SANAS accredited body – registration number ISO 22000 FSMS 14a and HACCP FSMS 14b.
“The Aspen Nutritionals facility complies with exports requirements to export dairy products certified by the Department of Agriculture (registration number ZA 5/44).”
Of course the regulatory environment also impacts on supply chain and the company procures raw materials through certified suppliers but even then, all incoming batches of raw materials are checked on identity and controlled by chemical, physical and microbiological methods.
“All products are manufactured according to Aspen Nutritionals’ prescribed production methods which form part of the Quality Assurance protocols. During the different stages of the manufacturing process including wet processing, spray drying, dry blending and filling, each batch is analysed for relevant chemical, microbiological and physical properties. The process is further controlled by continuously monitoring critical control points such as pasteurization.
“All quality control data is evaluated prior to final product being released to the market and data relating to all batches of product is systematically filed and stored.
“Aspen Nutritionals has always been, and remains committed to ensuring that when you purchase one of our nutritional products, you can do so with confidence and the assurance that Aspen Nutritionals’ quality products are scientifically manufactured in compliance with the highest international standards,” the company website explains.
Given the absolute precision involved in the manufacturing process (not to mention its necessity), it would be fair to describe the Clayville facility as a centre of excellence and an example of the standards set by the Aspen Group.
Little wonder then, that in April of 2016, the JSE-listed Group played host to Deputy President Cyril Ramaphosa and Minister of Health Dr Aaron Motsoaledi at its Port Elizabeth-based flagship manufacturing site.
The visit provided an opportunity to discuss Aspen’s economic growth and export contributions to South Africa, and to demonstrate its globally recognised specialized manufacturing technologies. Aspen is the leading supplier of medicines to the South African public and private sectors, with approximately 1 in 4 medicines dispensed in the public sector being an Aspen product.
Stavros Nicolaou, Aspen Senior Executive, Strategic Trade said, “The visit further strengthens the collaboration between Government and Aspen, and provides additional impetus to jointly finding home grown solutions to the challenges that face South Africa’s economic and healthcare system. This collaboration also dispels some myths that Government and the private sector are at odds with one another.”
“Aspen has significantly expanded its global footprint. It has an active presence in 76 countries and distributes product to more than 150 countries. This expansion has been mirrored by our ongoing investment in local manufacture which in the past 18 months has exceeded R2 billion, and which continues to contribute to economic growth and export prospects. Our more recent developments include a High Containment Suite to produce high potency and oncological products, and a second Small Volume Parental facility with highly specialised, pre-filled syringe capability for niche low molecular weight heparin injectables for domestic and offshore markets. We also produce the unique MDR-TB injection, Capreomycin (Capstat)® as well as more than 40 million units of Murine® eye drops, the USA’s second largest over the counter eyed drop brand.”
In his capacity as the Chairperson of the South African National AIDS Council (SANAC), Deputy President Ramaphosa said, “I salute Aspen for having the foresight to build these plants here in Port Elizabeth, therefore creating valuable high tech jobs. It allows us as Government to purchase medicines that Aspen produces at affordable prices.”
Nicolaou added that Aspen’s latest capex spend positions it as a global leader in a number of niche therapeutic areas, such as injectable anti-coagulants (thrombotics), infant nutrition and male and female hormonal health. This investment has further enabled it to re-locate off shore manufacture back into South Africa, which provides for significant export opportunities.
“Aspen has ambitious global plans in selected niche, specialist therapeutic areas. These plans are consistent with and aligned to Government’s industrialisation plans. We remain committed to an ongoing contribution to diversify South Africa’s economy, unlock local investments, further establish economic linkages with SME’s, provide job and export opportunities and contribute to the overall challenge of tackling the stubborn inclusive growth challenge we face. Aspen is proof that technology-driven companies will continue to significantly contribute to South Africa’s economic growth,” said Nicolaou.
Present at the visit was CEO of Proudly SA, Advocate Leslie Sedibe, who said, “Aspen’s investment in local manufacture and its state of the art facility is a clear demonstration of South Africa’s global competitiveness in support of DTI’s call to strengthen South Africa’s industrialization programme through the support for local products. Proudly SA supports Aspen’s achievements in this regard.”