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However, he clarified that the affected batch was not used to produce any commercially supplied batch, and therefore no product recall is required.“Based on the assessment conducted, we believe there is no patient safety risk associated with the product.
The GMP norms tracks quality, impurities, and stability specifications.
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Mumbai: Dr Reddy's Laboratories has halted the production and supply of its generic semaglutide injectable after identifying an impurity in the drug's active pharmaceutical ingredient (API) developed by the company.In an intimation to the stock exchanges, the Hyderabad-headquartered company said an “out-of-specification result” detected in certain batches, promoted to halt the production and commercial supplies of the product will be delayed for a certain period of time.Later, speaking to investors during an analyst call, Erez Israeli, CEO, Dr Reddy's Laboratories, said certain impurities were identified during the validation of the API. However, he clarified that the affected batch was not used to produce any commercially supplied batch, and therefore no product recall is required.“Based on the assessment conducted, we believe there is no patient safety risk associated with the product. The oral tablets remain unaffected, as they utilise different API source,” he added.Separately, Ahmedabad-based Torrent Pharma has iniatied a voluntary recall of select batches of its brand Semalix 2mg and 4mg injections, supllied by Dr Reddy's to the comoany.According to Israeli, the issue stems from a technology used in the production process, and the company is in the process of “tweaking” the process to achieve the ideal quality standards and resume production.Commercial distribution of the product will be completely halted for the remainder of the current quarter. However, the company is not liable to make any penalty for delays in fulfilling its supply commitments.If the remediation proceeds as planned, the company expects to begin supplying the API to its manufacturing partner, OneSource Specialty Pharma, from early October, with commercial distribution of the finished product likely to commence between “late October and early November,” Israeli said.While the company's target of supplying 12 million pens this fiscal year is likely to take a hit, the management expects to be “on track to supply 6–7 million pens in the remaining two quarters — Q3 and Q4.”The management reiterated its commitment to continue its partnership with OneSource and expects no material impact on its FY27 earnings guidance.Israeli told investors that no resubmissions or approvals are required from the relevant regulatory authorities to resume commercialisation after addressing the Good Manufacturing Practice (GMP) issue.The voluntary action is initiated for the batches produced with the newly sourced ingredient, while products already marketed remain unaffected. The company said no recall is required in either market.Dr Reddy's Laboratories was among the first drugmakers to launch a generic semaglutide injectable in India and first company to receive marketing approval for the product in Canada following the expiry of the patent earlier this year.In India, the drug is co-commercialised by Dr Reddy's, Torrent and Mumbai-based USV under separate brand names, while in Canada, the company oversees marketing itself.Over the coming months, the generic major was planning to roll out the drug in more than 70 countries, positioning itself as one of the early entrants to capitalise on the opportunity and establish first-mover advantage.In markets such as Canada, where the company currently faces limited competition, in its absence, the anticipated entry of competitors like Sandoz may erode its market position. However, management said it continues to view the therapy as a “long-term growth opportunity.”For using an API to manufacture a finished formulation, companies are required to validate that the processes used to manufacture and control an active ingredient are capable of consistently producing an API that meets predetermined quality specifications. The GMP norms tracks quality, impurities, and stability specifications.
