Pii to Manufacture FDA-Approved Hormone Therapy Injection Drug Product

Pharmaceutics International, Inc. (Pii), a contract development and manufacturing organization (CDMO) headquartered in Hunt Valley, MD, will manufacture 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," said Kurt Nielsen, president and chief executive officer, Pii. "Pii's Pharmaceutics Know-How platform 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."
 
Pii is a privately held CDMO providing dosage form development and cGMP manufacturing services to the global pharmaceutical industry. Pii's services include pre-formulation development, and clinical and commercial cGMP manufacturing of parenterals, liquid solutions and oral solids, including soft gels, tablets and capsules. In addition, the company offers containment suites to handle potent drugs and Schedules I-V controlled substances. 

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