The approved dosages—10 mg, 25 mg, 50 mg, 75 mg, 100 mg and 150 mg—are indicated for the relief of symptoms of depression. Amitriptyline Hydrochloride is a tricyclic antidepressant commonly prescribed to manage major depressive disorders.
The approval allows JB Chemicals to introduce its generic formulation in the US market, further strengthening its regulated market offerings. This development is expected to aid the company’s long-term growth in international markets, particularly the United States, which remains a key focus for Indian pharmaceutical exporters.
While the company has not disclosed the timeline for launch or potential market size, Amitriptyline is part of a well-established therapeutic segment with consistent demand.
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JB Chemicals has been steadily expanding its global footprint, supported by a diversified pipeline and investments in contract development and manufacturing. In its March quarter earnings, reported last month, the company posted a 15.5% year-on-year rise in net profit to ₹145.7 crore, driven by growth across domestic and CDMO businesses.
Shares of JB Chemicals closed at ₹1,799.60 on the NSE on Tuesday, up 0.21% ahead of the announcement.
