IRVINE, Calif.--(BUSINESS WIRE)--Alliance Medical Products ("AMP”) announced today, at the AAPS Annual Meeting and Exposition, the U.S. Food and Drug Administration (FDA) has granted approval to manufacture a certain commercially available ophthalmic product using the company’s high speed dropper bottle filling line.
“The FDA's approval to manufacture another commercial product in our facility further demonstrates AMP's ability to bring our customers' products successfully from clinical through commercial manufacture," said Juan Valdes, President and CEO. "Over the years, we have enjoyed repeated success in transferring our customers' products to our 54,000 square foot facility in Irvine California and scaling those products up to full commercial manufacture."
The product is approved for immediate manufacture using AMP's high speed Capmatic Patriot dropper bottle filling line. The line is capable of filling 5,000 to 30,000 units per shift with container sizes ranging from 3mL to 30mL.
Steve Tulk, Vice President of Business Development and Kevin O’Brien, Director of Sales, will be available to discuss the company’s capabilities during the exposition.
“We are very pleased to be participating in this premier industry conference,” said Valdes. “We look forward to the opportunity to discuss our capabilities in person and further develop relationships with new and existing customers."
ALLIANCE MEDICAL PRODUCTS, INC. is a full service cGMP, FDA and ISO13485 drug, device and combination product contract manufacturer providing developmental, clinical and commercial contract manufacturing services to large and small organizations. AMP specializes in difficult to manufacture formulations that include solutions, suspensions, emulsions, sterile ointments and gels with the capability to fill an array of container closures including vials, dropper tip bottles, screw cap bottles, cartridges and squeeze tubes. AMP has extensive manufacturing capabilities which include four high volume automated aseptic filling suites and three semi-automated low volume aseptic filling suites. In addition to its manufacturing capabilities, AMP maintains state of the art micro and analytical laboratories, and the capability to provide stability services meeting all ICH guidelines.
The AAPS Annual Meeting and Exposition takes place on
- Sunday November 14th, 2010 through Thursday November 18th, 2010
- at the Morial Convention Center, New Orleans, LA.
- This event marks AMP’s eighth consecutive appearance at the AAPS Annual Meeting.
If you’d like more information about AMP, or to schedule a meeting, please contact Steve Tulk at 949-454-4582 or email Steve at firstname.lastname@example.org