Dr. Reddy's Laboratories Flags Semaglutide Supply Delay, Says No Recall Risk

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Sun, July 12, 2026 astatine 4:02 PM CDT 5 min read

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Dr. Reddy's Laboratories said a scale-up contented involving the API for its semaglutide injection volition hold commercialized supply, aft an impurity was recovered retired of specification during validation testing. The institution said the occupation is tied to caller validation batches, not antecedently shipped material.
Management stressed determination is no callback oregon diligent information concern, due to the fact that products already sold to the marketplace were not affected and stay safe. The contented besides does not impact the company's existing planetary regulatory filings oregon its oral semaglutide tablets.
Dr. Reddy's expects validation enactment could beryllium completed astir September, with commercialized proviso perchance restarting successful precocious October oregon aboriginal November if successful. The hold means the institution volition miss immoderate expected income successful the July-to-October period, though request for semaglutide remains strong.

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Dr. Reddy's Laboratories (NYSE:RDY) said a scale-up contented tied to the progressive pharmaceutical constituent for its semaglutide injection volition temporarily hold commercialized supplies, though absorption emphasized that products already supplied to the marketplace are not affected and bash not rise diligent information concerns.

Chief Executive Officer Erez Israeli said connected a institution telephone that Dr. Reddy's identified an out-of-specification impurity during investigating connected to the validation of a scaled-up synthetic API manufacturing process. The API itself met specifications, helium said, but an impurity degraded during formulation investigating of the finished cause product.

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"While the API itself met the specification, 1 of the impurities were recovered to beryllium retired of specification upon testing," Israeli said. He added that the contented was identified successful scale-up validation batches and was "not related to the aged worldly that we sent."

Commercial proviso expected to resume aft validation

Israeli said Dr. Reddy's is investigating the basal origin and volition marque process adjustments earlier repeating validation. The institution expects to nutrient 3 validation batches, nonstop them to OneSource for cause merchandise manufacturing, and implicit testing, including sterility testing.

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Based connected the company's existent timeline, Israeli said the enactment could beryllium completed astir September. If successful, commercialized API proviso to OneSource could resume successful October, with merchandise proviso to the marketplace perchance restarting successful precocious October oregon aboriginal November.

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