Two men have been jailed and another handed a suspended sentence, for selling more than three million doses of prescription-only and unlicensed medicines, including controlled medicines.
The distribution giant, McKesson Corporation, has agreed to pay the DEA's record fine of $150m after allegedly failing to report “suspicious orders” for controlled substances.
Drugmakers must include a transaction identification number when buying or selling machinery for tabletting or encapsulating controlled substances, according to a final ruling from the US DEA.
Cambrex will acquire clinical-scale API maker PharmaCore for $25m adding a standalone GMP facility in North Carolina approved to make Schedule II to V products.
The DEA's mismanagement of the controlled substance API quota system and its poor relationship with the FDA have exacerbated drug shortages according to the US GAO.
Patheon has received approval from the DEA to bulk manufacture the schedule I product Gamma Hydroxybutyric Acid (GHB) from its facility in Cincinnati, Ohio.
Eisai has accused the US FDA of unlawfully shortening market exclusivity periods for Belviq and Fycompa by starting the countdown one year before either was scheduled by the DEA.
Access to mixed hydrocodone painkillers such as AbbVie’s Vicodin will be restricted and production limited if plans by the US Drug Enforcement Administation (DEA) are cemented later this year.
Pharma industry employees and wholesalers with access to narcotic APIs would be subject to background checks and drug testing under new proposals being considered in the US.
The DEA has approved AMRI’s Burlington facility to work with Schedule 2 controlled substances, placing it in a competitive position to win contract manufacturing bids, the company says.
Ampac gets the OK from the DEA, Syngene lands PE-ED manufacturing contract and Great Southern is bought by Pernix Therapeutics – welcome to Outsourcing-pharma.com’s CMO round-up.
Outsourcing-Pharma presents a round-up of the latest headlines within the world of contract manufacturing. Catalent and Patheon have each launched oral dosage partnership news, whilst Frontage and AMPAC have received regulatory go-aheads.
Siegfried is to supply at least 60 per cent of Jazz Pharmaceutical’s global requirement for sodium oxybate, the active pharmaceutical ingredient (API) in Xyrem.
Purdue Pharma is the first drug manufacturer to implement a new
software program that allows firms to order all Schedule I & II
controlled substance purchases on a single electronic form -
potentially saving up to 90 per cent...