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.
Analysis Scores
Earnings Impact8/10
Growth Catalyst9/10
Governance Concern1/10
Regulatory Risk2/10
Balance Sheet Risk4/10
Liquidity Impact9/10
Market Sentiment9/10
✦ Ask a Question
Ask anything about this announcement — AI will answer based on the filing content.
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".
Attachments (1)
📄pdf
Download →
Cadilahc_21082026135055_PressRelease21082026.pdf
View document text
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)