India Pharma Outlook Team | Tuesday, 16 September 2025
At its biologics production facility in Bachupally, Hyderabad, and Dr. Reddy's Laboratories Ltd. revealed that the US Food and Drug Administration (US FDA) had issued them a Form 483 with five observations. From September 4–12, 2025, the regulator conducted a pre-approval inspection at the location.
The corporation promised to resolve the observations within the allotted time frame in a file to the stock exchanges. The inspection comes after a previous evaluation conducted in October 2023 at the same plant. Dr. Reddy's stock ended Friday's trading session on the NSE at ?1,314, up 0.84 percent.
The Hyderabad-based pharmaceutical company said earlier this week that it had reached a final deal with Johnson & Johnson subsidiary Janssen Pharmaceutica NV to purchase the Stugeron portfolio for $50.5 million.
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India and Vietnam are two of the major growing markets in the 18 Asia-Pacific and EMEA markets covered by the transaction. For vertigo and vestibular problems, doctors recommend Stugeron, which contains the antihistamine cinnarizine.
In the first quarter of FY26, Dr. Reddy's recorded sales of ?8,542 crore, up from ?7,672.7 crore in the same period last year.The amount exceeded the ?8,676.4 crore poll prediction from CNBC-TV18.Although it was little below than analyst projections, net profit was ?1,417.8 crore, up from ?1,392 crore the previous year.
In contrast to the poll forecast of ?2,201.6 crore, EBITDA came in at ?2,287 crore. For the current fiscal year, the corporation has set its goals for flat margins and double-digit topline growth.
