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(25 Jun 2025, 12:22)

JB Chemicals receives USFDA approval for Amitriptyline Hydrochloride tablets

JB Chemicals & Pharmaceuticals announced that it has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Amitriptyline Hydrochloride Tablets USP.


The approved dosages—10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg—are indicated for the treatment of symptoms of depression. Amitriptyline Hydrochloride is a tricyclic antidepressant widely prescribed for managing major depressive disorders.

JB Chemicals & Pharmaceuticals manufactures a wide range of pharmaceutical formulation specialties, radio-diagnostics, APIs, and intermediates.

The company's consolidated net profit rose 15.5% to Rs 145.69 crore on a 10.2% rise in revenue to Rs 949.48 crore in Q4 FY25, compared with Q4 FY24.

Shares of JB Chemicals & Pharmaceuticals rose 0.10% to Rs 1,800.60 on the BSE.

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