CMP Pharma and Kiel Laboratories Sign Development Agreement for Two NDA Products
CMP Pharma (formerly Carolina Medical Products Co.) and Kiel Laboratories have signed an agreement to develop, seek regulatory approval, and commercialize two new prescription drugs. The first drugs will be directed at the general population with special emphasis on the geriatric market, followed by a product to be directed at the pediatric market.
While both drugs already exist as FDA approved solid dosage forms, CMP will be filing NDAs to obtain approval for an alternate liquid dosage form.
Commenting on the agreement, Gerald Sakowski, CEO of CMP Pharma, said, “These two products are excellent complements to our line of niche specialty pharmaceutical products. This is another chapter in our long history of developing stable, ready-to-use liquid dosage forms that make life easier on the consumer, the physician, and the pharmacist.”
CMP Pharma is a specialty pharmaceutical company located in Farmville, NC that develops and manufactures a portfolio of high-value topical and liquid oral dose pharmaceutical products. The company was founded in the early 1980s around the development of a ready-to-use liquid dosage form for sodium polystyrene sulfonate, a drug used for the treatment of hyperkalemia.
Kiel Laboratories, Inc., a privately held company established in 1991 by Dr. Jeff Kiel provides a full spectrum of drug development, regulatory, and intellectual property services. Kiel specializes in the identification of, and regulatory strategies around 505(b)(2) and orphan drug NDA submissions. Kiel Laboratories, Inc. is located in Flowery Branch, GA.