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Lupin Receives Approval from U.S. FDA for Chlorpromazine Hydrochloride Tablets USP

Lupin Receives Approval from U.S. FDA for Chlorpromazine Hydrochloride Tablets USP

Global pharma major Lupin Limited (Lupin) announced that its wholly-owned subsidiary, Lupin Inc., based in Somerset, New Jersey, has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg, to market a generic equivalent to the reference listed drug (RLD), Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg of Upsher-Smith Laboratories, LLC. This product will be manufactured at Lupin’s Somerset facility in the U.S. Chlorpromazine Hydrochloride Tablets USP had an estimated annual sale of USD 45 million in the U.S. (IQVIA MAT Mar 2023).

 

 

More news about: quality / gmp | Published by Sudeep Soparkar | July - 18 - 2023 | 314

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