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India’s Lupin gets FDA nod to make generic oral contraceptive

India’s Lupin Ltd. has the USFDA nod for making a generic birth control pill, according to a company statement.

HQ Team

August 2, 2023: India’s Lupin Ltd., the eighth largest generic pharmaceutical company in the world based on revenue, has received the USFDA nod for making a generic birth control pill, according to a company statement.

The FDA approved its Abbreviated New Drug Application for Turqoz pill, which is being norgestrel, and ethinyl estradiol tablets.

The medicine is a generic equivalent of Lo/Ovral-28 of Wyeth Pharmaceuticals LLC and will be manufactured at Lupin’s Pithampur facility in India’s central Madhya Pradesh state.

Norgestrel and ethinyl estradiol tablets had an estimated annual sale of USD $34 million in the US during March 2023, according to research firm IQVIA.

5.8% CAGR

The birth control pill contains two types of hormones, norgestrel and ethinyl estradiol, and when taken properly, prevents pregnancy. It works by stopping a woman’s egg from fully developing each month. The egg can no longer accept a sperm and fertilization is prevented.

This oral contraceptive also contains ferrous fumarate. Ferrous fumarate is an iron supplement.

No contraceptive method is 100 percent effective. Birth control methods such as having surgery to become sterile or not having sex are more effective than birth control pills.

The global contraceptive pills market size stood at $13.11 billion in 2018 and is projected to reach $20.55 billion by 2026 — a CAGR of 5.8% during the forecast period, according to Fortune Business Insights.

Tydemy recall

Separately, Lupin Pharmaceuticals Inc. was voluntarily recalling two lots of Tydemy — Drospirenone, Ethinyl Estradiol, and Levomefolate Calcium Tablets and Levomefolate Calcium Tablets — due to out-of-specification test results at the 12-month stability time point.

One lot of the birth control pill tested low for ascorbic acid, an inactive ingredient, and high for a known impurity, according to an statement from the USFDA.

The lots were distributed nationwide in the US to wholesalers, drug chains, mail order pharmacies and supermarkets.

“To date, Lupin has received no reports of adverse events related to either recalled batches,” according to the statement.

Lupin is recalling these two batches because if there was significant reduction in the amount of inactive content (ascorbic acid), this could potentially impact the effectiveness of the product which could potentially result in an unexpected pregnancy.

Lupin Pharmaceuticals, Inc. Is the US-based wholly-owned subsidiary of Lupin Limited and is the third largest pharmaceutical company in the US based on total prescriptions.

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