Alchem International is a leading global manufacturer of natural nicotine, nicotine salts and nicotine complexes for use in tobacco substitutes, including e-cigarettes, white snus, nicotine patches, nicotine gums and nicotine lozenges.
Since their introduction in 2006, e-cigarettes have reached an estimated global market value of 19.3 billion USD in 2019. With their exceptional growth and popularity, e-cigarettes have posed a challenge to other smoking cessation products as well as to the tobacco cigarette industry. Their rapid growth is expected to continue as consumers chose to avoid tobacco products. In the US, all nicotine products are now regulated under the US FDA tobacco Deeming Regulations with the requirement to file PMTAs (pre-market tobacco approval). As of 2016, with the application of the European TPD (tobacco Product Directive), the e-liquid and e-cigarette market is more regulated to ensure a consistent product quality and provide a reference for European consumers.
Alchem International NicSelect™ liquid nicotine is manufactured to the highest possible quality standards under pharmaceutical cGMP conditions and subject to rigorous analytical controls to ensure the highest purity and lowest impurity levels. This ensures compliance with even the strictest regulations as well as guarantees outstanding quality and consistency. We have filed a tobacco Product Master File (TMPFs) for Nicotine USP with the US FDA to support our customers tobacco Product Master Files (TMPFs) applications and REACH and TPD compliant for Europe.
The global market size of nicotine replacement therapy (NRT) products reached just above 3 billion USD in 2014 – an increase of almost 300% in a decade. The most common forms are gums, inhalers, lozenges, nasal sprays, skin patches. Today, the market size is similar to those of e-cigarettes and is still growing strongly as new delivery devices are developed and consumers are looking for alternatives to their current tobacco products.
Alchem International produces pharmaceutical-grade liquid nicotine and nicotine powder complexes specifically for these applications in cGMP certified facilities and supported by Drug Master Files (DMFs) for medicinal registration.
White snus is a modern take on loose snus or tobacco pouches that have been popular for many years in Scandinavia, East Europe and Russia.
White snus is a cleaner version of chewing tobacco, tobacco snus or tobacco snus pouches with nicotine on a carrier line like microcrystalline cellulose or a powdered nicotine such nicotine bitartrate dihydrate or nicotine salicylate contained a small pouch offering a dryer, less drip and a longer-lasting flavor release that remains completely white before, during and after use.
Alchem International NicSelect™ nicotine powders are manufactured under pharmaceutical cGMP conditions, with the US FDA to support our customers tobacco Product Master File (TMPFs) applications and we are REACH compliant for Europe and have filed a tobacco Product Master File (TMPFs) for Nicotine bitartrate dihydrate.
Product |
Quality |
Application |
Regulatory |
Documentation |
|
|---|---|---|---|---|---|
| NicSelect™ Nicotine EP / USP | Premium grade pure nicotine | cGMP | Pharma | USDMF, EDMF | Technical data sheet MSDS, cGMP certificate |
| NicSelect™ Nicotine EP / USP | Premium grade pure nicotine | cGMP | E-liquids | US FDA, TPMF filed, REACH, TPD | Technical data sheet MSDS, cGMP certificate |
| NicSelect™ Nicotine blend, Standard blend: 100 mg/ml | Premium grade nicotine blends ‘ready to flavor’ | cGMP | E-liquids | USDMF, EDMF, REACH | Technical data sheet, MSDS, GMP certificate |
| NicSelect™ Nicotine EP / USP | Premium grade nicotine salt bases ‘ready to flavor | cGMP | Pharma | REACH, TPD | Technical data sheet MSDS, GMP/ISO certificate |
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