Pii to Manufacture FDA-approved Busulfan Injection Drug Product


HUNT VALLEY, Md., March 15, 2019 — Pharmaceutics International, Inc. (Pii), a Contract Development and Manufacturing Organization (CDMO) headquartered in Hunt Valley, Maryland, is pleased to announce the launch of Busulfan Injection, 6mg/mL in 10mL vials, in partnership with Athenex Pharmaceuticals, Sungen Pharma and Chemwerth.  Pii is responsible for all commercial production and Athenex will market and distribute the product in the U.S.  Busulfan Injection is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia. 

“We are pleased to announce the licensing and launch of Busulfan Injection (FDA approved 9/21/2018) through our collaborative partnership.  Pii’s Pharmaceutics Know-How allows us to not only work with our partners to develop and assist in expediting their own pipeline opportunities, but to also enter into strategic relationships that leverage valued synergies.  Busulfan Injection is the 4th injectable product approved by the FDA, for Pii and its partners, during the past two years,” said Dr. Kurt Nielsen, Pii’s President and CEO.

About Pharmaceutics International, Inc.
Pii is a privately held CDMO providing dosage form development and cGMP manufacturing services to the global pharmaceutical industry. Headquartered in Hunt Valley, Maryland USA, 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.  For more information, please visit www.pharm-int.com.

Kurt R. Nielsen, Ph.D., President and CEO

Pharmaceutics International, Inc.

10819 Gilroy Road
Hunt Valley, MD 21031

Phone: (410) 584-0001

Email: knielsen@pharm-int.com

SOURCE Pharmaceutics International, Inc.

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