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Lupin gets USFDA approval for Meclizine Hydrochloride Tablets USP

The product is an equivalent of Antivert Tablets, 12.5 mg, 25 mg, and 50 mg, of Casper Pharma LLC. It will be manufactured at Lupin’s facility in Goa, India.
  • Published On Aug 12, 2022 at 03:50 PM IST
Read by: 100 Industry Professionals
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Mumbai: Lupin Limited announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) of Meclizine Hydrochloride Tablets USP.

The Meclizine Hydrochloride Tablets 12.5 mg, 25 mg, and 50 mg, to market a generic equivalent of Antivert Tablets, 12.5 mg, 25 mg, and 50 mg, of Casper Pharma LLC will be manufactured at Lupin’s facility in Goa.

Meclizine Hydrochloride Tablets (RLD Antivert) had estimated annual sales of USD 29 million in the US.
  • Published On Aug 12, 2022 at 03:50 PM IST
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