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How Parimer Helped Onshore an Important International Drug to the U.S.
The project included the redevelopment of a drug substance originally developed in Japan for the international market; However, it had never received US FDA approval. The client approached Parimer to develop a synthetic process to manufacture this drug substance in the USA and support the Chemistry, Manufacturing, and Controls (CMC) needed to get the drug through its Investigational New Drug filing (IND).
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