Pharmascience's generic Paliperidone Palmitate Prolonged-Release Injectable Suspension received for review by the FDA
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MONTREAL, Nov. 12, 2019 /PRNewswire/ - Pharmascience Inc. is proud to announce that the US Food and Drug Administration (FDA) communicated on October 31, 2019, that the abbreviated new drug application (ANDA) for Pharmascience's generic version of Paliperidone Palmitate Extended-Release Injectable Suspension prefilled syringes, is accepted for review. Paliperidone Palmitate is indicated for the maintenance treatment of schizoaffective disorder.
"We at Pharmascience are extremely proud of this very important milestone," said Jack Gagnon, Vice President and General Manager, Pharmascience International, "This achievement is a testament to our capabilities in the development of complex injectable and solid oral formulations. Pharmascience is one of the few companies in North America that specialize in these complex formulations." Pharmascience is committed to collaborating with the FDA to meet all requirements leading to the approval of Paliperidone Prolonged-Release Injectable Suspension. About Pharmascience Founded in 1983, Pharmascience Inc. is one of the largest pharmaceutical manufacturers in Canada with over 1,500 employees, and an international presence spanning 60 countries. Pharmascience's global presence and agile business development model provide patients and healthcare communities around the world with the same quality medicines as are dispensed in Canada. Its R&D team has the extensive expertise necessary for the development of complex injectable and solid oral generic drugs. Pharmascience has been distributing high-quality, FDA certified generic products in the US since 2017 from our Candiac site. Since its inception in 1983, Pharmascience has invested over $500M in research and development and ranks amongst the top generic manufacturers in Canada, offering over 300 product families in more than 20 dosage forms. In Canada alone, more than 45 million prescriptions a year are filled with Pharmascience products.
SOURCE Pharmascience Inc. |
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