Alliance Medical Products, Inc. (AMP) has received commercial approval of its automated IMA tube filling line. The line is currently being used for the commercial manufacture of a sterile ophthalmic ointment recently approved by the FDA.
“The approval of this drug and AMP’s automated IMA tube filling line further solidifies our company's reputation as the industry’s leading cGMP supplier of difficult to manufacture formulations,” said Juan Valdes, president and chief executive officer. “The IMA line has a capacity of 30,000 tubes per shift with tube size diameters ranging 10 to 60 mm with volumes ranging from 1 to 50 grams.” The line will be used primarily to fill sterile gels, creams and ointments.
“AMP’s innovative process design expertise was a key factor in achieving these approvals. 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,” said Mr. Valdes.
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