Shares of JB Chemicals and Pharmaceuticals Ltd were trading in the green and 2% higher on 25 June after the business received USFDA approval for its Amitriptyline Hydrochloride Tablets.

In its regulatory filing, the company said, “the company has received approval from United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA), Amitriptyline Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg.”

As a tricyclic antidepressant, Amitriptyline is commonly prescribed for managing major depressive disorders.

This approval enables JB Chemicals to introduce its generic version in the US, reinforcing its presence in regulated markets. The move is expected to support the company’s long-term international growth, especially in the US, which is a key export destination for Indian pharmaceutical firms.

Although JB Chemicals hasn’t disclosed the product’s launch timeline or target market size, Amitriptyline remains part of a mature therapeutic segment with steady demand.

The company continues to expand globally, backed by a robust pipeline and strategic investments in contract development and manufacturing (CDMO). In the March quarter, JB Chemicals reported a 15.5% year-on-year increase in net profit to Rs 145.7 crore, driven by strong performance in both domestic and CDMO segments.

At 12:16 pm, the shares of JB Chemicals were trading 0.01% higher at Rs 1,799.30 on NSE.

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