firstwordpharmaJanuary 05, 2017
Tag: ANDA , generic injectable products
Custopharm, Inc., a U.S. leader in generic injectable products, announced today that it has acquired two paragraph IV abbreviated new drug application (ANDA) products from Perrigo Company plc.
The company has attained full-ownership rights to acetaminophen injection ("acetaminophen") and testosterone undecanoate injection ("testosterone"). Acetaminophen is indicated for the management of mild to moderate pain and reduction of fever in the clinical setting. Testosterone is indicated for testosterone replacement therapy in adult males.
"Both of these products are a tremendous fit with Custopharm's already diverse offering of specialized and high barrier generic pharmaceutical products," said Dr. William Larkins, chief executive officer, Custopharm. "Our team is excited to acquire these products and begin preparations to bring lower-cost alternatives to these product categories."
Custopharm has developed more than 30 pharmaceutical products over the past ten years. In 2015, the company partnered with Water Street Healthcare Partners, a strategic investor focused exclusively on the health care industry, to invest in and expand its capabilities. In the past year, the company has more than doubled its laboratory capacity and team of analytical and formulation scientists and technology transfer process engineers.
Custopharm plans to market the acetaminophen and testosterone products under its new commercial business arm, Leucadia Pharmaceuticals. The company is pursuing new opportunities to collaborate with pharmaceutical and biotechnology companies and expand its product portfolio.
About Custopharm
Custopharm is a generic injectable drug services company. The company specializes in developing a range of generic injectable products, including those with complex formulations. Custopharm also offers regulatory consulting services to help customers with drafting and filing abbreviated new drug applications. Headquartered in Carlsbad, Calif., Custopharm has grown to work with more than 100 pharmaceutical companies since its founding in 2005. Custopharm is a company of Water Street Healthcare Partners, a strategic investor focused exclusively on the health care industry.
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