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Lupin receives tentative approval from USFDA for birth control pill

Lupin receives tentative approval from USFDA for birth control pill

Lupin receives tentative approval from USFDA for birth control pill
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By CNBCTV18.com Nov 4, 2022 5:20:25 PM IST (Updated)

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

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Pharma major Lupin Ltd. announced that it received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Drospirenone Tablet.


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

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

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

Lupin develops and distributes a wide range of generic and branded formulations, biotechnology products, and active pharmaceutical ingredients (APIs) in over 100 markets. It is the third-largest pharmaceutical company in the US by prescriptions.

CNBC-TV18 recently accessed details to 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 various lapses on part of the company.
The Tarapur plant produces API ingredients and had received the warning latter in September.
The manufacturing facility was inspected by the USFDA from March 22 to April 4, 2022.
Shares of Lupin ended 0.3 percent lower at Rs 709.80.
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