Zydus Lifesciences has received final approval from the U.S. Food and Drug Administration (FDA) for its abbreviated new drug application for Ascorbic Acid Injection USP, 25,000 mg/50 mL (500 mg/mL), 5,000 mg/10 mL (500 mg/mL).

The product, primarily used for the short-term treatment of scurvy, is a generic of reference listed drug Ascor Injection. The USFDA has designated the ANDA as a competitive generic therapy. Eligibility for the 180-day exclusivity available to certain CGT is determined by the U.S. FDA and where applicable the period runs from the date of first day of commercial marketing of the product, Zydus said.

The product will be manufactured at the group’s injectable manufacturing plant in Jarod, near Vadodara and marketed in the US by Zydus Pharmaceuticals (USA) Inc. The brand product had annual sales of $11.6 mn in the U.S., Zydus said, citing IQVIA MAT June-2026 numbers.

Zydus Lifesciences and Sunshine Healthcare Lanka have formed a joint venture to establish a $20 million pharmaceutical manufacturing facility in Sri Lanka.

Foundation stone of the nearly four acres facility of Zydus Sunshine Lifesciences, the joint venture company, at the Board of Investment zone in Horana was laid on Friday (June 26, 2026).

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Coming against the backdrop of Sri Lanka prioritising domestic production in essential sectors, the plant will strengthen local production, contribute to a reduction in import dependence and improve access to high-quality medicines. The plant will manufacture pharmaceutical products for Sri Lanka’s retail market.

The equal Joint Venture (JV), which combines Zydus’ global expertise in pharmaceutical manufacturing and technical know-how with Sunshine’s strong local market presence and healthcare distribution capabilities, will support technology transfer, build local manufacturing capability and create employment. “It will contribute to the long-term development of Sri Lanka’s healthcare ecosystem,” the companies said.

“This collaboration marks an important step in strengthening Sri Lanka’s healthcare ecosystem and building sustainable pharmaceutical capabilities for the future,” Zydus Lifesciences managing director Sharvil P. Patel.

Group CEO Sunshine Holdings PLC Shyam Sathasivam said the partnership is a strategic investment in Sri Lanka’s healthcare security and industrial growth.