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Our Bureau

New Delhi , May 26

ALEMBIC has received USFDA approval for its active pharmaceutical ingredients (API) product Leflunomide, a company statement said.

"It is significant to note that the USFDA has accorded this approval without any non-compliance issues under clause 483. This is an indication of the high standards of the manufacturing facility including the well designed systems and processes," it added. Leflunomide has a market of $196 million in the US and $7.7 million in Canada and the company plans to achieve a significant share of these markets, according to the statement.

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Alembic gets USFDA nod for Leflunomide

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