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.
First up is Ampac Fine Chemicals – a subsidiary of American Pacific Corporation – which has been granted registration as a manufacturer of controlled substances by the US Drug Enforcement Agency (DEA).
The contractor has been developing and producing Schedule II substances since 2008 under a research license. However, the reclassification – which follows a revamp of the firm’s plant in Rancho Cordova, California - means it can now make them for commercial-scale according to APC president Aslam Malik.
"We are pleased to add controlled substance commercial manufacturing to the value proposition that we bring to our customers. This major milestone enhances our position as a fine chemical supplier with world-class cGMP manufacturing capabilities in the United States.”
Next to hit the headlines is Indian contract research and manufacturing services (CRAMS) firm Syngene, which has been contracted to produce a combination treatment for premature ejaculation (PE) and erectile dysfunction (ED) by developer Ampio Pharmaceuticals.
Few details of the manufacturing contract have been disclosed other than that it will speed up plans to test the drug in Asia.
CEO Michael Macaluso said: “Ampio entered into an agreement with Syngene to begin manufacturing the combo product for the conduct of a Phase III trial for these co-morbid conditions in South Korea by our partner Daewong.”
Back in the US contract manufacturing organisation (CMO) Great Southern Laboratories has announced that it will be acquired by fellow Texas-based Pernix Therapeutics.
Pernix will pay $4.9m for Great Southern, including its facilities located in Houston, in a deal expected to complete later this month.
The specialty pharma’s CEO, Cooper Collins, said the takeover “will enable us to develop products more rapidly and provide in-house product development expertise.
“We plan to utilize this facility to manufacture certain products currently marketed by Pernix, as well as future branded, generic and OTC products, as we continue to expand and diversify our product portfolio."
Pernix has not said if Great Southern – which makes liquids, tablets, capsules, ointments and creams for pharmaceutical companies – will continue to operate as a CMO.
And finally this week it is Netherlands-based vaccine and allergy drug producer HAL Allergy which has expanding its contract manufacturing capabilities.
The firm – which set up its CMO business in 2009 – added clean room and development labs at its facility at Bio Science Park in Leiden, which were cleared by the Dutch authorities late last month.
CEO Harry Floe said: “The fact that the Dutch authorities extended our GMP permit, is a big step forward in our goal of becoming a key biotech service company.”