The procurement of pharmaceutical raw materials can present a major challenge due to the complexities involved. Chutrau, an Argentine expert on the marketing of raw materials and excipients, today reviewed the current regulatory requirements at a symposium in Buenos Aires.
The recent closures of two Argentine laboratories highlight the importance of complying with regulatory mandates related to the manufacturing of pharmaceutical products. With that in mind, Chutrau, local experts in the marketing of raw materials and excipients, were quick to convene the industry’s leading buyers for a technical symposium that delved into all aspects of the responsible procurement of pharmaceutical supplies.
The event, attended by Pharmabiz, was held at the Recoleta Grand Hotel in Buenos Aires this morning. The opening keynote address was delivered by the company’s general manager, Adrián Carnevale, who welcomed the guests and provided context for the meeting. He discussed the complexity of international logistics brought about by the COVID-19 pandemic and the vital role of procurement departments in keeping the supply chain running.
Next up, Lorena Zuccarelli, the company’s technical director, focused on the regulatory framework and its impact on the supply of excipients. The expert stressed that putting the patient first must always be the guiding principle. She also emphasized the importance of understanding the regulator’s position. She then addressed the definition of raw materials under current legislation, as well as the concepts of APIs and excipients, which she noted are governed by a strict regulatory framework.
Reviewing key definitions, she noted that legislation refers to a raw material is any active or inactive substance used in the manufacture of a medicine and that is involved in the finished product. This includes: APIs, that is, substances with a direct therapeutic action, and excipients. The latter are substances that do not have therapeutic activity but are necessary to formulate the medicine. See Regulation 2819 of 2004 in Spanish.
She explained that, according to local regulations, these products must have a certificate of analysis demonstrating their quality, and their origin must be traceable from the supplier to the finished product. They must be stored under controlled temperature and humidity conditions, and their reception, sampling, analysis and release must be carried out by qualified personnel.
Zuccarelli warned that there is a constant risk of unauthorized suppliers coexisting in the market, often with storage spaces that do not meet temperature and other technical requirements. They may even present falsified certificates of analysis that do not correspond to the marketed batch. She said untrustworthy operators were a risk when prioritizing price alone, and that resulting production can be ineffective, or worse, dangerous. Fines, closures and even the loss of licenses can result.
Natalia Figueron, part of Chutrau’s team, focused her presentation on the development phases of a pharmaceutical product and outlined the classification of excipients. She emphasized that these inactive ingredients can significantly improve product administration. She also discussed the company’s broad portfolio of lactose and cellulose products and encouraged attendees to explore in detail the options that best meet each need. Lactose is currently the star excipient, and also one of the most prone to irregular marketing.
Finally, she addressed the topic of nitrosamines. These chemical compounds have come under scrutiny in recent years after the FDA found impurities in several products and issued a massive recall that put valsartan and other drugs in the spotlight.
Another speaker at the event was Fernanda Pentagna, a representative of DFE Pharma, the European drugmaker headed since January by Sven Abend. The firm has maintained a strategic alliance with Chutrau as the exclusive representative of its excipients business in Argentina for more than two years. See Press Release
The Brazilian executive came to Argentina specifically for the seminar and conducted a live survey from the stage on the current state of corporate purchasing. She asked whether price was the most important variable or whether paying a little more for excellence can prevent problems that could have been avoided. See website
Later, she reviewed the dynamics of the raw materials market, mentioning how mergers between companies directly impact on the purchasing process, as re-validation between parties is required. She also mentioned the time during the pandemic when there was an international shortage of lactose. She explained that DFE Pharma was able to easily resolve this situation and highlighted the company’s strength as an international supplier.
