The inspection, conducted between June 16 and June 25, 2026, resulted in the issuance of a Form 483 with seven observations, which the company said it will address within the stipulated timeline.
What is a Form 483
A Form 483 is a list of observations made during the inspection and is issued by the USFDA inspectors after the completion of the inspection. The inspector will communicate and explain these observations to the supplier during the closing conference. But a Form 483 does not represent a final FDA determination regarding the facility’s GMP compliance.
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Post Form 483 is issued, the company is given 15 days to submit its response to the USFDA explaining what steps the company will take to resolve the observations made by the USFDA.
Last week, Dr Reddy’s Laboratories announced the launch of Bosutinib Tablets 400 mg in the US, marking the first generic version of Bosulif to enter the market.
The launch strengthens Dr Reddy’s oncology portfolio and aligns with its strategy of expanding access to cost-effective treatment options for patients.
The company said the product was launched in collaboration with MSN Laboratories. Under the partnership, MSN handled the development and manufacturing of the medicine, while Dr Reddy’s holds exclusive marketing rights for the US market.
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Bosutinib Tablets 400 mg were filed under the first-to-file category, making it eligible for 180 days of generic drug exclusivity in the US for this dosage strength. Such exclusivity provides the first generic entrant with a temporary period of limited competition, potentially supporting market share gains.
According to IQVIA data, sales of the reference drug Bosulif 400 mg stood at approximately $253.8 million in the US during the 12-month period ended April 2026.
Milan Kalawadia, CEO of North America at Dr Reddy’s Laboratories, said the launch reflects the company’s focus on bringing important therapies to market quickly while improving affordability and access for patients and healthcare providers. He added that the company remains committed to expanding its oncology offerings and strengthening partnerships across the healthcare ecosystem.
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Bharat Reddy, Executive Director at MSN Laboratories, said the launch highlights the company’s capabilities in developing, manufacturing and commercialising complex oncology products, while reinforcing its commitment to supplying affordable medicines globally.
Shares of Dr Reddy’s Laboratories Ltd ended at ₹1,351.00, up by ₹22.65, or 1.71%, on the BSE.
(Edited by : Jomy Jos Pullokaran)
First Published: Jun 25, 2026 11:21 PM IST
