JB Chemicals and Pharmaceuticals Ltd has received final approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Amitriptyline Hydrochloride Tablets USP, marking a significant milestone in the company's US market expansion strategy.
FDA Approval Details
The FDA approval covers six dosage strengths of Amitriptyline Hydrochloride tablets: 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg. All formulations conform to United States Pharmacopeia standards and are indicated for the relief of symptoms of depression. Amitriptyline Hydrochloride is a tricyclic antidepressant commonly prescribed to manage major depressive disorders.
The approval enables JB Chemicals to introduce its generic formulation in the US market, further strengthening the company's regulated market offerings. This development is expected to support the company's long-term growth in international markets, particularly the United States, which remains a key focus for Indian pharmaceutical exporters.
Market Position and Financial Performance
JB Chemicals has been steadily expanding its global footprint, supported by a diversified pipeline and investments in contract development and manufacturing. The company's recent financial performance reflects this growth trajectory, with net profit rising 15.5% year-on-year to ₹145.7 crore in the March quarter, driven by growth across domestic and CDMO businesses.
Amitriptyline represents part of a well-established therapeutic segment with consistent demand, though the company has not disclosed the timeline for launch or potential market size for this specific product.
Market Response and Analyst Outlook
Shares of JB Chemicals closed at ₹1,799.60 on the NSE on Tuesday, up 0.21% ahead of the announcement. The stock has demonstrated mixed performance over different timeframes, rising 2.58% over the last 12 months while declining 2.44% on a year-to-date basis.
Analyst sentiment remains strongly positive, with 14 out of 15 analysts tracking the company maintaining 'buy' ratings, while one recommends 'hold'. The average 12-month analysts' price target implies a potential upside of 11.4%, reflecting confidence in the company's growth prospects and market expansion strategy.
