Pii to Manufacture FDA-Approved Hormone Therapy Injection Drug Product
HUNT VALLEY, MD (September 23, 2019) - Pharmaceutics International, Inc. (Pii), a Contract Development and Manufacturing Organization (CDMO) headquartered in Hunt Valley, Maryland, is pleased to announce the commercial supply of Fulvestrant Injection 250mg/5ml drug product, which was recently approved by the FDA. Pii will be responsible for all commercial drug product production and Sagent Pharmaceuticals, the ANDA holder, will sell, market and distribute the drug product in the U.S.
“We are pleased to support Sagent Pharmaceuticals in its efforts to supply an affordable treatment option for post-menopausal patients suffering from breast cancer. Pii’s Pharmaceutics Know-How™ has once again proven valuable to one of our partners, as they strive to develop and provide approved drug products to patients in need. Fulvestrant Injection 250mg/5ml drug product is the 5th injectable product approved and produced by Pii, during the past two years,” said Dr. Kurt Nielsen, Pii's President and CEO.