Lupine Receives Usfda Tentative Approval for Birth Control Pill

By CNBCTV18.com STI (Update)

Drospirenone 4mg tablets are a generic market equivalent of Slynd tablets, which are produced by Exeltis USA Inc.

wealth desk
wealth desk

Pharmaceutical major Lupine Ltd. announced that it has received interim approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for drospirenone tablet.

Drospirenone 4mg tablets are a generic market equivalent of Slynd tablets, which are produced by Exeltis USA Inc.

Slynd tablets have an estimated annual revenue of $141 million in the United States, according to IQVIA annual data ending September 2022.

The tablets contain two types of hormones and are used in the prevention of pregnancy.

Lupine develops and distributes a wide range of generic and branded formulations, biotechnology products and active pharmaceutical ingredients (APIs) in more than 100 markets. It is the third largest pharmaceutical company in the United States by prescriptions.

CNBC-TV18 recently accessed details of the warning letter issued by the USFDA for the company’s Tarapur plant. The warning letter includes manufacturing errors, failure to establish proper written procedures for cleaning equipment, and other miscellaneous failures on the part of the company.

The Tarapur factory produces API ingredients and had received the latter’s warning in September.

The manufacturing facility was inspected by the USFDA from March 22 through April 4, 2022.

Shares of Lupine ended down 0.3% at Rs 709.80.

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