Boehringer Ingelheim Chemicals Inc (BICI) is investing in its manufacturing facility in Petersburg, US, to install capacity to produce phenylephrine. Sister company Boehringer Ingelheim Pharma already manufactures it in Germany and is the world's largest producer, but the expansion in Petersburg marks the first time the company will manufacture the product in the US.
Dr Anthony Corso, president and chief operating officer at BICI, said the expansion at the Petersburg facility will begin this year. In addition to installing equipment, the project also involves transferring the company's proprietary and patented production process and technology from Ingelheim to Petersburg.
Demand for phenylephrine hydrochloride is being fueled by an increasing need to replace pseudoephedrine in cough and cold products. Pseudoephedrine is a precursor chemical that, when misused, can be used to make the drug methamphetamine, also known as "speed." Phenylephrine hydrochloride cannot be used in making methamphetamine, and there are no restrictions on its use, as there are with pseudoephedrine.
In the US, 13 states have passed laws or regulations that control access to pseudoephedrine at the retail level. Some laws, for example, require retail stores to keep cold tablets containing pseudoephedrine behind the pharmacist's counter or in locked cabinets, while other laws limit the quantity that can be purchased at a time or within a 30-day period.
Additionally, a bipartisan group of 12 US senators introduced a bill in late January to limit consumer sales nationwide of medications containing pseudoephedrine.
For pharmaceutical manufacturers, the various restrictions on pseudoephedrine can lead to higher costs for packaging, transportation and Drug Enforcement Administration compliance, while also reducing or eliminating prime shelf space for these products at the retail level.
"The trend towards increasing the use of phenylephrine as an alternative to pseudoephedrine will escalate," predicted Corso. "Phenylephrine has been used as a nasal decongestant successfully in the US and Europe for many years. Its use in the US will continue to grow as additional states and the federal government consider further restricting access to pseudoephedrine."