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Pii to Manufacture Busulfan Injection Drug Product

Busulfan Injection is the 4th injectable product approved by the FDA for Pii and its partners

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By: Kristin Brooks

Managing Editor, Contract Pharma

Pharmaceutics International, Inc. (Pii), a CDMO headquartered in Hunt Valley, MD, in partnership with Athenex Pharmaceuticals, Sungen Pharma and Chemwerth, have launched Busulfan Injection, 6mg/mL in 10mL vials.  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 chief executive officer.

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