“Aphena has a long history of CII packaging and an excellent compliance record with the FDA and DEA for over 15 years,” said Eric Allen, executive VP of sales and marketing, Aphena. “We have partnered with leading pharmaceutical companies to supply CII-V packaging, including both generic and brand medications.”
Anticipating significant growth in child-resistant compliance packaging for opioids and other products regulated by DEA and FDA, Aphena earlier this year added a new CII vault that more than quadrupled the current controlled pallet spaces. The company is also running nine packaging lines with serialization aggregation for blisters and bottles at its Cookeville, TN, site.
“We can offer a large variety of blister tooling on site, which can handle both small and large doses of products for tablets, capsules and soft gels,” said Paul Glintenkamp, Aphena’s director of business development. “Additionally, our new blister line from PharmaWorks can accept existing tooling from our other blister packaging lines.”
Aphena has partnered with providers of compliance packaging technologies and can offer “off-the-shelf” or customized options for CII and child-resistant/senior-friendly package designs, including blisters, carding and reclosable systems. These also include clinically tested designs with the F=1 child-resistant/senior-friendly designation.
With two separate FDA- and DEA-registered, GDUFA-compliant and serialization-ready sites in the U.S., Aphena handles solid dose, liquids, gels, creams, ointments, foams, suspensions and lotions.