Zydus Lifesciences received final approval from the US Food and Drug Administration (USFDA) for Ascorbic Acid Injection, indicated for the treatment of scurvy, along with a 180-day CGT exclusivity period.

Approval highlights

The approved product is manufactured at a USFDA-approved facility located in Gujarat. The following table summarises the key details of this regulatory approval:

Product specifics

The USFDA approved the Abbreviated New Drug Application (ANDA) for Ascorbic Acid Injection USP in two strengths: 25,000 mg/50 mL (500 mg/mL) and 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 aged 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 brand product had annual sales of approximately USD 11.6 mn in the United States, according to IQVIA data for the month ending June 2026.

Regulatory significance

The 180-day CGT exclusivity grants Zydus Lifesciences a defined period during which it holds a competitive advantage in the US market for this product. Eligibility for this exclusivity is determined by the USFDA, and the period runs from the date of the 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. It will be marketed in the US market by Zydus Pharmaceuticals (USA) Inc.

Portfolio update

With this approval, the group now has 448 approvals and has so far filed 513 ANDAs with the USFDA as on June 30, 2026.

Zydus Lifesciences has received a USFDA Establishment Inspection Report (EIR) for its injectable facility, with the United States Food and Drug Administration assigning a Voluntary Action Indicated (VAI) classification to the inspection outcome.

Regulatory Development

The issuance of an EIR by the USFDA marks the formal closure of a facility inspection. The VAI classification, assigned in this instance, signifies that any observations noted during the inspection are considered minor in nature and do not warrant mandatory regulatory action from the USFDA. This is generally regarded as a favourable regulatory outcome for pharmaceutical manufacturing facilities.

Key Highlights

The following table summarises the key details of this regulatory development:

The VAI classification is one of three possible outcomes following a USFDA facility inspection, the others being No Action Indicated (NAI) and Official Action Indicated (OAI). A VAI status indicates that the inspected facility met the required standards with only voluntary corrective actions, if any, needed.

This regulatory clearance pertains specifically to Zydus Lifesciences' injectable manufacturing facility, underscoring the company's compliance standing with one of the world's most stringent pharmaceutical regulatory authorities.