The plant has been registered for over 30 years with the US Drug Enforcement Administration (DEA) to manufacture schedule II to V products, but in a document published by the Department of Justice today, Patheon has been granted registration as a bulk manufacturer of Gamma Hydroxybutyric Acid, a basic class of controlled substance listed in schedule I.
Patheon Pharmaceuticals – part of DPx following the $2.65bn merger with Royal DSM’s pharma product business in March – applied for the registration back in January in order to manufacture the controlled substance for distribution to its customers.
“The DEA investigated the company's maintenance of effective controls against diversion by inspecting and testing the company's physical security systems, verifying the company's compliance with state and local laws, and reviewing the company's background and history,” the document said.
The 46,000m2 high-volume facility specialises in controlled release formulations as well as the development and manufacturing of Liquid-Filled Hard Capsules (LFHC), which the firm says is an ideal dosage form to meet formulation challenges associated with low solubility or high-potency compounds.
GHB is a naturally occurring substance found in the central nervous system, but if synthesised can be used as an anaesthetic or to treat insomnia, narcolepsy and clinical depression. It has also gained infamy as both a recreational narcotic and a date-rape drug, which is why its production is strictly controlled by the DEA.
However, while making GHB requires schedule I approval, formulating it into a finished product does not which is why Patheon has been able to make Jazz Pharmaceutical's Schedule III cataplexy treatment, Xyrem, under contract since 2008.
Whether schedule I approval will see Patheon also begin making the Xyrem active pharmaceutical ingredient (API) - currently supplied by Swiss chemicals firm Siegfried under a contract due to expire in 2018 - is unclear.
While no such plan has been anounced, Jazz's assertion in its most recent annual report that: “Although Siegfried has been our only supplier of sodium oxybate since 2012, we have the right to purchase a portion of our worldwide requirements of sodium oxybate from other suppl;iers" suggests Patehon could now be another option.