Brokerage Sounds Bullish on Zydus Lifesciences after USFDA Nod

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The brokerage argued that “the USFDA’s acceptance clears an earlier regulatory hurdle that was linked to manufacturing inspection observations.

By S JHA

Mumbai, December 16, 2025 — Brokerage raised outlook for the Zydus Lifesciences after a key nod from the USFDA nod. ICICI Direct in a research note said that the USFDA nod is a shot in the arms for the stock of Zydus Lifesciences. The stock closed with minor cut on Tuesday. The shares of Tuesday were trading at ₹910.

“Zydus Lifesciences has received USFDA acceptance for its ANDA of copper histidinate (CUTX-101).

CUTX-101 is intended for the treatment of Menkes disease in paediatric patients,” added the brokerage in its research note.

It also stated that “the resubmission has been accepted as a Class I response by the USFDA. The acceptance follows an earlier Complete Response Letter issued due to cGMP inspection observations at the manufacturing site.”

The brokerage argued that “the USFDA’s acceptance clears an earlier regulatory hurdle that was linked to manufacturing inspection observations rather than product safety or effectiveness.” “With the resubmission now accepted, the regulatory process for CUTX-101 moves forward, easing uncertainty around the filing for this niche paediatric treatment,” it added.

The Ahmedabad headquartered Zydus Lifesciences Limited is an Indian multinational pharmaceutical company. It provides total healthcare solutions, including formulations, active pharmaceutical ingredients (APIs), vaccines, biosimilars, animal healthcare products, and consumer wellness products.

Shares of Zydus Lifesciences have also been flat for past six months. Incidentally, stocks across sectors have seen corrections in the last six months.

(Disclaimer: This article makes no recommendation for buy or sell of shares of any company)