Depression medication: JB Pharma gets USFDA nod for Amitriptyline Hydrochloride Tablets

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2025-06-25 06:39 GMT | Update On 2025-06-25 06:39 GMT

Mumbai: J.B. Chemicals & Pharmaceuticals Limited has received approval from United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA), Amitriptyline Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg.

The product is indicated for relief of symptoms of depression.

Depression or depressive disorder, is a common mental health condition that can happen to anyone. It is characterized by a low mood or loss of pleasure or interest in activities for long periods of time.

This is different from regular mood changes and feelings about everyday life. Depressive episodes last most of the day, nearly every day, for at least two weeks. People with depression may experience disturbed sleep and changes to their appetite. They may have feelings of low self-worth, thoughts about dying and hopelessness about the future. Tiredness and poor concentration are also common.

Depression results from a complex interaction of social, psychological and biological factors. People who have lived through abuse, severe losses or other adverse events are more likely to develop depression.

It is estimated that more than 75% of people experiencing mental disorders in low- and middle-income countries receive no treatment

Established in 1976, J.B. Pharma is a pharmaceutical company headquartered in Mumbai, India. Besides India presence, which accounts for majority of its revenue, its other two home markets are Russia and South Africa. The company exports its finished formulations to over 40 countries including the USA. Besides supplying branded generic formulations to several countries, it also manufactures medicated lozenges. It has eight state of the art manufacturing facilities in India including a dedicated manufacturing facility for lozenges. The manufacturing facilities are certified by leading regulators across the world.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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Depression medication: JB Pharma gets USFDA nod for Amitriptyline Hydrochloride Tablets

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