FDA Approval of First Twice-Daily, Nano-Milled Ocular Corticosteroid
HARLEYSVILLE, Pa., Jan. 22, 2019 /PRNewswire/ -- Alliance Contract Pharma (ACP) is pleased to announce that one of our clients has received FDA approval for the first twice-daily ocular corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery. This product represents a breakthrough in post-surgery care that can help increase the rate of successful outcomes.
ACP supported the development of this product through a range of phases: formulation development, clinical supply, process validation, FDA inspection and approval, and launch.
"The most rewarding aspect of the years of quality-driven hard work, is seeing the success of the client's FDA approval and the positive impact on the company's future," says Benjamin W. Reed, Vice President, Manufacturing. "The thoughtful determination through all aspects of the drug life cycle enabled the ease of commercialization. We look forward to helping our other clients repeat this cycle with their own products."
ACP develops and manufactures a wide range of dosage forms, from discovery to distribution. We offer a cost-effective, scale optimization experience from prototype batches to commercial scale. Our facility is audited by European Union Quality Personnel and FDA inspectors for multiple processes.
ACP is proud to have contributed to this recent milestone in ocular care and looks forward to offering its experience to future breakthroughs.
About Alliance Contract Pharma
Alliance Contract Pharma CDMO is a privately owned contract manufacturing pharmaceutical company that was incorporated in 2008.
We are a leader in the pharmaceutical industry, providing our customers with value-added analytical laboratory and manufacturing contract services. These include liquid-filled capsules, nano milling suspensions, and terminally sterilized injectables in our ISO 7 & ISO 8 cleanroom suites. We manufacture APIs/HPAPIs from formulation to commercial scale. We offer analytical method development, qualification and validation and your API, in-process or finished product, as well as ICH stability storage.
Our pledge is to establish long lasting relationships with all of our customers by exceeding their expectations and gaining their trust, by always providing the highest quality service at an economical cost.