Zydus Lifesciences shares rise as US FDA approves Ascorbic Acid injection with 180-day CGT exclusivity

According to a regulatory filing, the pharma major received the approval for Ascorbic Acid injection, 25,000 mg/50 mL (500 mg/mL), 5,000 mg/10 mL (500 mg/mL).

The product is primarily used for the short-term treatment of scurvy in adult and paediatric patients age 5 months and older for whom oral administration is not possible, insufficient or contraindicated, the company said.

The product will be manufactured at the group’s USFDA-approved injectable manufacturing plant at Jarod, near Vadodara in Gujarat, and will be marketed in the US market by Zydus Pharmaceuticals (USA) Inc, it further stated.

Ascorbic Acid injection is the generic equivalent of the reference listed drug (RLD), Ascor Injection, 25,000 mg/50 mL (500 mg/mL).

The USFDA also designated the ANDA for the product as a CGT. “Eligibility for the 180-day exclusivity available to certain competitive generic therapies is determined by the USFDA and, where applicable, the period runs from the date of first day of commercial marketing of the product,” the firm said.

The brand product had annual sales of approximately $11.6 million in the United States, Zydus Lifesciences added, citing data from IQVIA.

The group now has 448 approvals and has, as of June 30, 2026, filed 513 ANDAs with the US FDA.

Zydus Lifesciences stock performance

Shares of Zydus Lifesciences were trading in the positive territory on Friday, August 21, following the announcement. At 2:25 PM, the stock stood at ₹1,109.40 per equity share, marking a 0.15% increase, compared with Thursday’s closing price of ₹1,107.70 per unit.

The shares have fallen 2% in the past week and 3% over the month. However, on a year-to-date (YTD) basis, they have gained 21%.

While the scrip hit a 52-week high of ₹1,205 apiece on August 12, 2026, it touched a year’s low of ₹835.50 per equity share on April 2, 2026.

Zydus Lifesciences Q1 results

The company reported a 35.93% year-on-year (YoY) fall in its consolidated net profit to ₹939.8 crore for the April-June quarter of the 2026-27 financial year (Q1 FY27), as against ₹1,466.8 crore in the year-ago period.

Its revenue from operations jumped 20.74% YoY to ₹8,123.1 crore during the quarter under review, compared with ₹6,728.6 crore in the first quarter of the 2025-26 fiscal year (Q1 FY26).

The firm’s earnings before interest, taxes, depreciation, and amortisation (EBITDA) declined 7.6% YoY to ₹1,929.4 crore in the June quarter of FY27, as against ₹2,088.5 crore in the year-ago period.

Its EBITDA margin contracted by 770 basis points (bps) YoY to 24.1% for the reporting quarter, in contrast to 31.8% in Q1 FY26.

Zydus Lifesciences has a total market capitalisation of ₹1.11 lakh crore as of August 21, 2026, according to data on the NSE.