Local Production to Boost National Self-RelianceThu, 04/29/2021 - 15:33
Q: What are the goals for Grupo Neolpharma’s new injectables plant?
A: This plant will produce injectables that have been in high demand during the current COVID-19 pandemic. It will produce norepinephrine, midazolam and other anti-inflammatory medicines. This plant will also pack COVID-19 vaccines in large quantities of about 150 million vials a year. This would be the equivalent of a vial for every Mexican.
The new plant is now finished and has received COFEPRIS’s manufacturing authorization. But before we are able to begin production, we need to obtain the Good Manufacturing Practices certificate, which is being processed. The COVID-19 pandemic did delay the plant’s outfitting as many foreign experts were unable to travel to Mexico, which was necessary to install state-of-the art equipment.
We expect to be able to inaugurate the plant in April 2021 thanks to the hard work of all our collaborators. One of the main challenges of an injectables plant is training its operators as hygiene and safety protocols are much stricter than in a solids plant.
Q: How will the new plant allow the company to expand its presence in the Mexican and foreign markets?
A: When the plant is fully operational, we will first focus on the Central America and Mexican markets. Our current injectables plant is at overcapacity, which led to this investment. From the design stage, we conceived that this plant would eventually manufacture products for the US. While this will not be an immediate outcome, we spent the entirety of last year training over 50 employees in the intricacies of manufacturing for the US market. This will ensure that our local production meets the needs of that market. As we have one plant in the US, we are fully aware of the processes required to produce in accordance with the FDA.
Q: How is Grupo Neolpharma helping to fight the COVID-19 outbreak in Mexico?
A: We have made several medicines readily available to Mexicans, such as azithromycin, paracetamol and others used by the government to fight the COVID-19 pandemic. Grupo Neolpharma has also worked with researchers and universities in the development of a COVID-19 vaccine, including UNAM and a university in Queretaro. Our biotechnology plant is able to manufacture the proteins necessary to produce COVID-19 vaccine. At this point, we have created enough doses for pre-clinical studies in animals to determine safety and effectiveness. We are ready to support Phase 1 and 2 clinical trials.
However, Mexico’s government offers little support for medical research into vaccines. One doctor working on the project told me that local universities have invested about US$1.5 million in the development of a COVID-19 vaccine. In comparison, the US government gave a single pharmaceutical company over US$1 billion in grants. While there is little support in the project from local authorities, we are sure to finish our Phase 1 and 2 clinical trials.
Q: How were Grupo Neolpharma’s API production capabilities affected by COVID-19?
A: Mexico is dependent on APIs from China, India and increasingly from the EU. COVID-19 had a significant impact on the global production and supply of APIs. For example, India, a large manufacturer, saw its exports affected. Due to the increased attention to medications, India’s government had to issue a new approval process for the export of APIs, which affected our manufacturing operations. These circumstances helped us recognize that there are significant opportunities to manufacture APIs in Mexico and eliminate our reliance on foreign countries. Minister of Economy Tatiana Clouthier is strongly supporting the local manufacturing of APIs as it is becoming increasingly apparent that countries should be more autonomous in their API production. This has benefited Grupo Neolpharma and we are now tripling API production at one plant.
Moreover, USMCA requires that North America increases its regional API manufacturing and supply capabilities, so we are exploring the construction of a new, larger manufacturing plant. For the construction of this plant, we are finalizing a loan agreement with the World Bank’s International Finance Corporation (IFC). To determine which APIs to manufacture at this plant, we are studying consumer habits in Latin America. We are considering medications in cardio-metabolic, obesity, central immune system, skeletal muscle and other specialties that have grown in prevalence during the pandemic. Before making a decision, we also need to consider changes to the current administrations’ healthcare policies.
Q: How does the public sector fit into the company’s evolving market strategy?
A: Mexico’s public healthcare system remains a priority for Grupo Neolpharma, especially considering the government’s goal of making healthcare access universal. Universal healthcare is a slow, gradual process that now can be seen in the updated medication catalogs at public hospitals. We are also registering more products on public hospitals’ basic lists to continue growing our presence in the public healthcare sector. We are among the Top 3 sellers to the public healthcare sector by volume.
All our products, whether capsules, injectables, effervescent or liquid, are manufactured with the highest quality standards, which allows us to remain competitive. Moreover, as a family company, we are working on cost containment and increased productivity through the use of new technology. For example, we recently bought 10 high-speed mixers, which run at 500 blisters per minute.
In 2020, we saw double-digit growth thanks to our market strategy. We are operating in different sales channels; if one lags, the others pull the company ahead. We are strengthening our digital sales platform and training our human resources. The company has high expectations regarding our new sales platform, especially as Mexicans are increasingly aware that they have to look after their health through high-quality, accessible medications. Our well-known quality has helped us create a loyal client base, which gives us high hopes for the future.
Grupo Neolpharma is one of Mexico’s largest pharmaceutical companies. It specializes in manufacturing, packaging and storage of pharmaceutical products. The company has several plants in Mexico, the US and Central America.