Lupin Secures USFDA Nod for Diazepam Injection, Targets USD 77.9 Million Market
DSIJ Intelligence / 01 Aug 2026 / Categories: Mindshare, Trending
Lupin has strengthened its US generics business after securing USFDA approval for Diazepam Injection, opening up an opportunity in a USD 77.9 million market.
Lupin Ltd on Friday announced that it has received approval from the US Food and Drug Administration (USFDA) for its Diazepam Injection USP, 10 mg/2 mL (5 mg/mL), Single-Dose Prefilled Syringes, expanding its injectable product portfolio in the United States.
The approval has been granted under the Federal Food, Drug, and CoSMEtic Act (FD&C Act) for the company's abbreviated new drug application (ANDA).
Lupin's Diazepam Injection has been approved as a bioequivalent version of Valium Injection 10 mg/2 mL (5 mg/mL) marketed by Hoffmann-La Roche Inc. The medicine is indicated for the management of anxiety disorders and the short-term relief of symptoms associated with anxiety.
According to IQVIA data for the 12 months ended May 2026, the reference product recorded estimated annual sales of USD 77.9 million in the US, highlighting the commercial opportunity for Lupin in the market.
The latest approval further strengthens Lupin's presence in the US generics market, which remains one of the company's largest revenue contributors. The company has continued to expand its portfolio by introducing complex generics and specialty pharmaceutical products across multiple therapeutic segments.
Lupin Ltd Share Price Performance
Lupin Ltd share price ended 0.26 per cent lower at Rs 2,415 on the NSE on Friday. During the session, the stock opened at Rs 2,428.40, touched an Intraday high of Rs 2,435, and slipped to a low of Rs 2,404.
Despite Friday's decline, the stock has gained 14.79 per cent so far in 2026.
About Lupin Ltd
Lupin Ltd is a global pharmaceutical company with operations across more than 100 markets. Its portfolio includes branded and generic formulations, complex generics, biotechnology products and active pharmaceutical ingredients.
The company has a strong presence in therapy areas such as respiratory, cardiovascular, diabetes, anti-infectives, gastrointestinal, central nervous system and women's health. Lupin operates 15 manufacturing facilities and seven research centres globally and employs more than 24,000 people. It also operates through subsidiaries including Lupin Diagnostics, Lupin Digital Health and Lupin Manufacturing Solutions.
Disclaimer: The article is for informational purposes only and not investment advice.