Lyne Laboratories

Lyne Laboratories can meet the unique challenges of the oral pharmaceuticals market. For more than 30 years, we've made it possible for manufacturers, distributors, and clinical and biopharmaceutical companies to take advantage of this special market niche. As a dedicated resource for late stage clinical and commercial-scale drug product manufacturing, we have a track record of bringing our customers' products to market efficiently, quickly, and with complete confidence.

As a result of our single-minded focus, we have an understanding of the science and the technologies involved in oral liquid pharmaceuticals. Our manufacturing solutions reflect this as well as our commitment to partnering with our customers. We view our facilities as an extension of our customers' operations and begin every partnership with a solid appreciation of their goals, needs, and expectations.

Our modern 65,000-ft. facility is complete with state-of-the-art manufacturing and packaging equipment, water systems, and CGMP-compliant facilities. Our high-speed rotary fillers can fill ≤ 250 containers/min in batch sizes from 100 to 10,000 L.

A fully staffed quality department and an up-to-date quality control laboratory support Lyne's comprehensive quality systems. We have a proven record of success with FDA preapproval and postvalidation inspections for PNDAs, NDAs, and ANDAs. At every stage - analytical, quality control, validation, and regulatory - our experienced staff performs and supports each of the activities required for an orderly and smooth manufacturing process. From efficient product transfer to on-time product delivery, we provide our customers with personalized attention and responsive service that reflects our company-wide commitment to customer satisfaction.