Following the FDA’s approval in March, India-based Lupin is launching its generic thiamine hydrochloride injection USP in the U.S. for treating vitamin B1 deficiency.
Pictured: Healthcare working holding an injection/iStock
Generics-focused Lupin Limited is launching its thiamine hydrochloride injection USP in the U.S. to treat vitamin B1 deficiency, the India-based pharmaceutical company announced Monday.
The news comes a few months after the FDA approved the abbreviated New Drug Application for the generic injection. The application was filed by Lupin’s partner and fellow Indian company, Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories Limited.
Designed to be a generic version of, and is therapeutically equivalent to, Fresenius Kabi’s thiamine formulation, Lupin and Caplin’s thiamine hydrochloride injection USP carries a 200 mg/2 mL dose and comes in multiple-dose vials. The product is expected to reach annual sales of $35 million, according to Lupin’s news release.
Thiamine deficiency arises due to low levels of vitamin B1, which can be caused by a diet that consists primarily of highly-processed carbohydrates like white sugar, flour and high alcohol intake levels. Some disorders, such as hyperthyroidism, prolonged diarrhea and some liver diseases, can also lead to thiamine deficiency, as can pregnancy.
The symptoms of thiamine deficiency are often vague and non-specific, such as fatigue, poor sleep, stomach pains, weight loss and irritability. However, if left unchecked, thiamine deficiency can worsen to beriberi, a condition that can cause nerve and heart abnormalities and other brain diseases.
Aside from Lupin and Caplin’s injection, thiamine deficiency can be treated through supplements, multivitamins and diet adjustments. In severe cases, high doses of thiamine are administered intravenously.
Lupin’s Monday announcement comes after months of back-and-forth with the FDA after the regulator flagged manufacturing issues at many of the company’s plants. In November 2022, the FDA issued a warning letter regarding Lupin’s Tarapur site, pointing out “significant deviations from current good manufacturing practice.”
In particular, the manufacturing site failed to establish sufficient written protocols for cleaning equipment, monitoring the progress and controlling the performance of processing steps. The Tarapur location also failed to examine and address these issues adequately.
In March 2023, the regulator again issued a letter to the company, listing 10 observations that could potentially indicate violations. These included the failure to document equipment failures and batch deviations, as well as subpar investigations of complaints.
Tristan Manalac is an independent science writer based in metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
