JB Chemicals & Pharmaceuticals Limited has informed the Exchange regarding 'ANDA Approval by US FDA'.
JBCHEPHARM · price
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Awaiting price reaction for this filing.
JB Chemicals & Pharmaceuticals has received approval from the US FDA for its Abbreviated New Drug Application (ANDA) for Amitriptyline Hydrochloride Tablets in six strengths: 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg. The product is indicated for the relief of symptoms of depression and will be a generic version that JB Pharma can now market in the US. The approval was communicated to the stock exchanges on June 24, 2025, by Sandeep Phadnis, Vice President – Secretarial & Company Secretary.
This approval strengthens JB Pharma's US generics portfolio and enables it to tap into the large US antidepressant market with a multi-strength generic product. However, Amitriptyline is a long-established, low-cost generic, so the immediate revenue contribution may be modest, and the stock impact is likely to be neutral to mildly positive.