Dr. Reddy's Laboratories has announced a temporary delay in the commercial supply of its semaglutide product after identifying a quality issue linked to the Active Pharmaceutical Ingredient (API) used in certain batches.
According to the company, some batches of semaglutide were found to be out of specification during quality assessments due to an issue associated with the API. Dr. Reddy's stated that it has initiated a detailed investigation to determine the root cause and is implementing appropriate corrective measures to ensure consistent product quality.
As a result of the ongoing investigation and quality assurance activities, commercial supplies of the product will be delayed for a limited period until the issue is resolved.
The company clarified that the quality issue does not impact patient safety and has no effect on existing global regulatory filings related to the product.
Dr. Reddy's reaffirmed its commitment to maintaining high quality standards and ensuring reliable global supplies of semaglutide, an important therapy used in the management of metabolic disorders.
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