NSEPress Release21 Aug 2026 · 21 Aug 2026, 01:52 pm

Press Release

Zydus Lifesciences Limited · ZYDUSLIFE

✦ AI Summary▲ PositiveOrder Win

Zydus Lifesciences Limited has received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Ascorbic Acid Injection, a generic equivalent of Ascor Injection, with 180-Days CGT exclusivity.

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Earnings Impact8/10
Growth Catalyst9/10
Governance Concern1/10
Regulatory Risk2/10
Balance Sheet Risk4/10
Liquidity Impact9/10
Market Sentiment9/10

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Full Announcement

Zydus Lifesciences Limited has informed the Exchange regarding a press release dated August 21, 2026, titled "Zydus announces final approval from the USFDA for Ascorbic Acid Injection with 180-Days CGT exclusivity".

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Cadilahc_21082026135055_PressRelease21082026.pdf

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August 21, 2026 BSE Limited Code: 532321 P J Towers, Dalal Street, Mumbai-400001 National Stock Exchange of India Limited Code: Zyduslife Exchange Plaza, C/1, Block G, Bandra-Kurla Complex, Bandra (East), Mumbai-400051 Re.: Press Release Dear Sir / Madam, Please find enclosed a copy of press release dated August 21, 2026, titled “Zydus announces final approval from the USFDA for Ascorbic Acid Injection with 180-Days CGT exclusivity”. The contents of the press release give full details. Please bring the aforesaid news to the notice of the members of the exchange and the investors’ at large. Yours faithfully, For, Zydus Lifesciences Limited Dhaval N. Soni Company Secretary and Compliance Officer Membership No. FCS7063 Encl.: As above Zydus announces final approval from the USFDA for Ascorbic Acid Injection with 180-Days CGT exclusivity Ahmedabad, India, 21 August 2026 Zydus Lifesciences Limited (Zydus) announces the receipt of final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ascorbic Acid Injection USP, 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. Zydus’ 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 has designated the ANDA for the product as a Competitive Generic Therapy (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 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. The brand product had annual sales of approximately USD 11.6 mn in the United States. (IQVIA MAT June-2026). The Group now has 448 approvals and has so far filed 513* ANDA with the USFDA. (*As on 30- June-2026)