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news.Alliance Medical Products (AMP) has received commercial approval of its automated IMA tube filling line, which is expected to be put to use immediately for the commercial manufacture of a sterile ophthalmic ointment recently approved by the FDA.
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AMP is a full service cGMP drug, device and combination product contract manufacturer providing developmental, clinical and commercial contract manufacturing services to large and small organisations.
AMP president and CEO Juan Valdes said that the IMA line has a capacity of 30,000 tubes per shift with tube size diameters ranging 10 to 60mm with volumes ranging from 1 to 50grams.
"These approvals open a new door for us, as we see nasal and otic drug products pushed into sterile filling along with ophthalmics which have long been packaged sterile," Valdes said.
AMP said that the line is expected to be used primarily to fill sterile gels, creams and ointments.