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A peek into Chemnovatic’s lab. Photo credit: Chemnovatic
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PureNic99+, marketed by Chemnovatic. Photo credit: Chemnovatic
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Anna Balconi, Alchem. Photo credit: Alchem
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Alchem’s STP in action in India. Photo credit: Alchem
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Alchem’s manufacturing facility in Neemrana, India. Photo credit: Alchem
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Nicotine distillation setup at Chemnovatic. Photo credit: Chemnovatic
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Tomasz Płaska, Chemnovatic. Photo credit: Chemnovatic
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Nicobrand’s QC lab. Photo credit: Nicobrand.CNT
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Mark McQuillan, Nicobrand Ltd. Photo credit: Nicobrand.CNT
Three globally leading manufacturers explain why pharmaceutical-grade nicotine is the tobacco sector’s new gold standard – or should be.
As the global nicotine industry undergoes a profound shift away from combustible tobacco toward reduced-risk products (RRP), the quality of nicotine itself has come under increasing scrutiny. Nicotine is now a highly engineered ingredient—refined, standardized, and reaching a quality level once reserved for pharmaceutical applications.
Pharmaceutical-grade nicotine is indeed widely regarded as the benchmark for purity, safety, and consistency across a growing spectrum of consumer products, from nicotine pouches all the way to e-liquids, heated tobacco products, nicotine gums, lozenges, and inhalers. Insights from three globally leading industry players—Chemnovatic, Alchem NicSelect, and Nicobrand Ltd. (part of Contraf-Nicotex-Tobacco GmbH, or CNT)—reveal a complex, highly technical, and rapidly evolving landscape where purity is not just a regulatory requirement, but a competitive differentiator.
Defining pharmaceutical-grade nicotine
At its most fundamental level, pharmaceutical-grade nicotine is defined through its compliance with internationally recognized pharmacopeial standards. “In simple terms,” explained Tomasz Płaska, marketing director of Chemnovatic, “pharmaceutical-grade nicotine is highly purified tobacco-derived nicotine that meets recognized pharmacopeial specifications such as USP/EP.” These standards encompass key quality parameters, including purity limits, he said, adding that, “at the same time, pharmacopeial compliance should be viewed as a baseline requirement rather than a differentiator, since meeting USP/EP standards alone does not necessarily guarantee the desired sensory profile.”
During a separate interview with Tobacco Asia, Anna Balconi, technical and regulatory manager at Alchem NicSelect, echoed Płaska’s view, emphasizing that such nicotine is “purified, standardized, and manufactured under strict GMP conditions,” ensuring it is suitable for both pharmaceutical applications and high-quality next generation products (NGP).
In addition, Mark McQuillan, managing director of Nicobrand, pointed out that meeting these monographs is only the beginning. “Whilst meeting the monograph might be the basic entry level, the scrutiny goes much deeper,” he noted, highlighting that extensive regulatory audits, testing above and beyond the monographs and answering detailed technical requests, are required for nicotine to be used in licensed medicinal products. Pharmaceutical-grade nicotine is, therefore, not just a specification—it is a system encompassing manufacturing processes, regulatory filings, and long-term safety validation.
From leaf to lab: The complexity of production
The journey from raw tobacco leaf to pharmaceutical-grade nicotine is anything but straightforward. Tobacco, as a natural material, contains a vast array of compounds beyond nicotine itself. “Nicotine extracted from tobacco is not a ‘clean single compound’ at the beginning of the process,” said Płaska.
Alongside nicotine, tobacco contains other alkaloids such as nornicotine, anabasine, and anatabine, together with numerous other naturally occurring compounds, including carbohydrates, proteins, phenolics, and organic acids. Płaska emphasized that, in practice, the key is not only how these impurities are removed but also how the process is designed to prevent unwanted compounds from being carried forward between stages.
Alchem’s Anna Balconi expanded on this complexity, noting the presence of “tobacco-specific nitrosamines (TSNAs), residual solvents, trace metals, pesticides, and volatile organic compounds.” These impurities may originate from soil conditions, agricultural inputs, curing processes, and even the extraction methods used.
Removing these substances requires a sophisticated, multi-stage purification process. Chemnovatic employs a “controlled, multi-stage purification approach,” combining extraction, distillation, and analytical verification. Alchem similarly relies on “distillation,
fractional separation, and proprietary advanced purification technologies,” all conducted under stringent GMP conditions. Nicobrand, in conjunction with its parent company CNT, have their own dedicated nicotine extraction facility in India, meaning that all potential impurities of nicotine are tightly controlled right from leaf extraction through to its final purification at its cGMP facilities in Northern Ireland and Switzerland.
The technical challenge lies in the chemical similarity between nicotine and many of its impurities. As Płaska explained: “Purification cannot rely on a single step only,” but demands a carefully orchestrated sequence of processes, each designed to remove specific compounds without compromising the integrity of the nicotine itself.
The pursuit of purity—and its limits
While pharmaceutical standards define acceptable impurity thresholds, leading manufacturers often exceed these requirements. For example, Chemnovatic reported achieving impurity levels “significantly below USP/EP limits,” with total impurities in some cases falling below 0.01%.
However, absolute purity is not always the ultimate goal. The more important objective is to achieve the right balance between pharmacopeial compliance, sensory performance, and batch consistency. This requires not only high-purity nicotine production to begin with, but also experience in how nicotine behaves in real formulations, such as e-liquids and nicotine pouches, where even trace impurities can influence sensory perception, odor profile, and overall formulation performance.
According to Tomasz Płaska, this is addressed by Chemnovatic’s four-step quality verification system, covering in-process laboratory analysis, finished product laboratory testing, sensory assessment of each batch, and final batch release based on complete analytical and quality documentation.
Alchem has taken this concept still further with its proprietary NOTES© system, which uses AI-driven analysis to evaluate and control organoleptic properties at parts-per-million (ppm) and parts-per-billion (ppb) levels. This allows the company to deliver what Balconi described as “one of the cleanest, purest, most stable and sensory-neutral nicotine available.”
From Nicobrand’s perspective, McQuillan highlighted the benefit of having worked with stringent regulatory healthcare bodies for decades, where demands go much further than just a Certificate of Analysis, culminating in Nicobrand’s/CNT’s products “always falling below any detectable limits for impurities.”
Why purity matters across product categories
The importance of pharmaceutical-grade nicotine varies depending on the end product, but its relevance is expanding across the board. In traditional nicotine replacement therapies (NRT)—such as patches, gums, lozenges, and inhalers—pharmaceutical-grade nicotine is effectively mandatory. These products are regulated as medicines, requiring strict adherence to pharmacopeial standards and GMP manufacturing.
On the other hand, for consumer products like e-liquids, nicotine pouches, and heated tobacco, the regulatory picture is more fragmented. “It depends primarily on the product category, not only on geography,” Płaska explained. While the European Union requires “high-purity ingredients” under its Tobacco Products Directive (TPD), it does not explicitly mandate pharmaceutical-grade nicotine for all products.
Nevertheless, Nicobrand’s Mark McQuillan argued that the RRP industry should consider a standard at least akin to medicinal nicotine, given the wider proliferation of these products. “The safest pitch is to say you should use a pharmaceutical-grade nicotine,” he stated, citing the “exemplary safety record of patches, gums, and lozenges for over 30 years” - incidentally using nicotine from Nico-brand/CNT.” This historical pedigree provides reassurance not only to regulators but also to consumers, many of whom still misunderstand nicotine’s role in tobacco-related harm.
Risks of lower-grade nicotine
Using non-pharmaceutical-grade nicotine introduces a range of risks, from sensory inconsistencies to regulatory non-compliance. Alchem’s Anna Balconi warned that apart from unpredictable product behavior, such materials may lead to “daily exposure to potentially harmful levels of toxic impurities.”
Tomasz Płaska added that the key issue is not simply whether nicotine is labelled as pharmaceutical-grade, but whether its quality is “sufficiently defined, controlled or documented.” Without rigorous standards and traceability, manufacturers face greater challenges in ensuring product safety and consistency.
Mark McQuillan pointed out the importance of controlling impurities such as heavy metals, residual solvents, and nitrosamines, noting that these can originate from both agricultural and processing stages. “These need to be tightly controlled and routinely monitored,” he told Tobacco Asia.
Global standards and regulatory frameworks
Pharmaceutical-grade nicotine is governed by a network of international standards, including the United States Pharmacopeia (USP), the European Pharmacopoeia (EP), and Good Manufacturing Practice (GMP) guidelines. Additional certifications—such as Certificates of Suitability (CEP) and Drug Master Files (DMF)—provide further validation of quality and compliance.
However, as all three companies pointed out, regulatory requirements vary significantly across markets. While the EU and US maintain relatively stringent frame-works, other regions may lack comprehensive regulations, creating opportunities for lower-quality products to enter the market.
This uneven landscape has contributed to instances of misrepresentation. Both Chemnovatic and Alchem have in the past reported cases where suppliers falsely labeled products as pharmaceutical-grade. “The industry does face instances of mis-representation,” Balconi acknowledged, reinforcing the need for independent audits, detailed documentation, and full traceability.
Supply chains, sustainability, and traceability
Purity aside, pharmaceutical-grade nicotine is also increasingly defined by the integrity of its supply chain. Chemnovatic’s STC Nicotine® framework, which covers sustainability, traceability and compliance, is an internally developed nicotine manufacturing standard that extends beyond pharmacopeial requirements. It integrates quality control, sustainable practices, involvement in the STP, and batch-level traceability, into one unified system designed to control and optimize each stage of nicotine manufacturing, supporting consistent quality, batch-to-batch repeatability and sensory consistency in demanding NGP applications.
Similarly, Alchem emphasized during the interview with Tobacco Asia its alignment with the STP, ensuring ethical sourcing and compliance with global ESG standards. Meanwhile, with Nico-brand’s parent company CNT being one of the largest tobacco leaf suppliers in the world since as early as 2015, it has utilized its knowledge of agronomy, tobacco, and experience of STP to initiate the implementation of its own Sustainable Nicotine Program (SNP), which fully encompasses STP and more. This mature program now involves some 12,000 farmers in India.
McQuillan explicitly stressed the importance of traceability, noting that customers now demand visibility “right back to the tobacco seed.” He went on to say that such supply chain integrity and ESG compliance is not an overnight fix and that would-be customers should look beyond any marketing information and “check under the hood” for concrete evidence on the ground.” This focus on traceability reflects a broader shift in the industry, where quality is no longer solely judged by chemical composition but also by the processes and ethics behind production.
Market dynamics and global production
Despite its growing importance, pharmaceutical-grade nicotine remains a relatively niche market in terms of volume. According to McQuillan, global production of pure nicotine is “maybe between 1,000 to 1,500 metric tons per annum,” far lower than commonly assumed.
Production is concentrated in three main regions: India, China, and Europe. Outside China, where consumption is largely domestic, India accounts for around 95% of the global nicotine extraction from tobacco leaf to produce crude nicotine, and around 65% of the downstream distillation and purification to convert crude nicotine to pharma-grade nicotine.
In Europe, nicotine production is also based on localized distillation and purification of India-produced crude nicotine, accounting for approximately 35% of the global production of pharma-grade nicotine. India’s key strategic role in the supply chain is closely linked to the country’s abundant cultivation of high content lower cost tobacco.
The main manufacturers globally of pharma-grade nicotine in India, including their respective certification levels, are Alchem (ICH WHO GMP, EDQM GMP) and BGP (ICH WHO GMP). Meanwhile, in Europe, the key players, including their respective certification levels, are Siegfried (Siegfried. ch) (SWISS MEDIC GMP), Nicobrand (MHRA GMP), A-Sense (ISO), and Chemnovatic (ISO).
India, in particular, is emerging as a major hub. Anna Balconi highlighted the advantages of “doorstep access” to tobacco in the country, while McQuillan noted India’s growing number of producers “who spring up opportunistically.” However, both interviewees emphasized that cost advantages must be balanced with stringent compliance and sustainability requirements.
Growth drivers and future outlook
Demand for pharmaceutical-grade nicotine is rising steadily, driven by the rapid expansion of RRPs. Chemnovatic reported “consistent, double-digit growth,” while Alchem attributed increased demand to “the rapid growth of next generation nicotine products” and heightened regulatory expectations.
Nicotine pouches, in particular, are a major growth driver. McQuillan divulged that these products tend to utilize more nicotine than e-liquids, for example, contributing to increased demand for high-purity nicotine. With projected compound annual growth rates (CAGR) of 30–35%, the category is poised to reshape the market.
At the same time, the industry faces ongoing challenges, including regulatory fragmentation, supply chain complexities, and the need to combat misinformation about nicotine. As McQuillan observed, there remains “a lot of nicotine illiteracy out there,” with many people – including regulators and even physicians - still equating nicotine itself with the harms of smoking.
Positioning in a competitive landscape All three companies interviewed rightfully position themselves as leaders in the pharmaceutical-grade nicotine space, each emphasizing different strengths. Chemnovatic highlighted its integrated production model, combining advanced distillation technologies with application-level expertise in NGPs, including e-liquids and nicotine pouch formulations. Alchem underscored its global scale, regulatory expertise, and innovative solutions such as NOTES©. And Nicobrand pointed out its decades-long track record in pharmaceutical applications and its extensive manufacturing capacity for nicotine active pharmaceutical ingredients (APIs) in addition to its well-established and class-leading SNP.
But, despite their differences, all three companies share a common focus on quality, compliance, and innovation. As Balconi put it, the industry is moving toward “an increasing convergence of pharmaceutical standards into mainstream consumer nicotine products.”
The gold standard for a new era pharmaceutical-grade nicotine has evolved from a niche requirement for medicinal products into a cornerstone of the modern nicotine industry. As RRPs continue to gain traction, the demand for high-purity, well-documented, and responsibly-produced nicotine will only intensify.
What emerges from the perspectives of Chemnovatic, Alchem NicSelect, and Nicobrand/CNT is a clear consensus: purity alone is no longer enough. The future belongs to manufacturers who can combine scientific rigor with transparency, sustainability, and a deep understanding of how nicotine performs in real-world applications. In an industry defined by transformation, pharmaceutical-grade nicotine stands as both a benchmark and a promise of quality, consistency, and a safer path forward.
Chemnovatic Sp. z o.o.
Founded in 2013 and headquartered in Lublin, Poland, with offices and ware-houses in the United Kingdom and Portugal, Chemnovatic operates a fully integrated production facility, combining nicotine distillation, production of nicotine salts, nicotine polacrilex, e-liquids and nicotine pouch mixes. The company’s STC Nicotine® framework underpins its approach to quality, sustainability, traceability, compliance and unified manufacturing standards across the nicotine manufacturing stages.
More info: chemnovatic.com
Alchem NicSelect
Part of Alchem International, established in 1935, Alchem NicSelect focuses on pharmaceutical-grade nicotine and next generation nicotine solutions. With manufacturing rooted in India and global operations spanning Europe and the US, the company serves a wide range of industries, from pharmaceuticals to vaping and oral nicotine products. It is known for its advanced purification technologies and proprietary NOTES© system.
More info: nicselect.com
Nicobrand Ltd./CNT GmbH
Nicobrand from Northern Ireland was acquired by CNT from a multinational pharmaceutical company in 2019. Both are recognized as the pioneers in pharmaceutical grade nicotine dating back to the 1980’s. Based in Northern Ireland, Nicobrand traces its origins back to the early 20th century and has been producing pharmaceutical-grade nicotine since the 1980s. The company supplies nicotine APIs and value-added formulations to a vast array of customers all over the world, both in the NRT and RRP sectors. Aside from its long-standing role in the development of nicotine replacement therapies, it has an excellent track record with regards quality, sustainability and security of supply.
More info: nicobrand.com