“…we wish to inform you that on July 29, 2026, the Company initiated a voluntary recall, at the retail/hospital level, 27, 923 vials (9,489 50 mL vials and 18,434 10 mL vials) of Pemetrexed Injection 100 mg/10 mL and 500 mg/50 mL (Pemetri RTU™) in the United States of America,” according to a stock exchange filing.
The recall was initiated on July 29, 2026, at the retail and hospital level and covers four batches — two of each strength. The affected products comprise 9,489 50 mL vials and 18,434 10 mL vials.
The company said the affected drug showed green to dark green discolouration, which is not consistent with the approved specification for appearance, defined as a clear, colourless to pale yellow to green-yellowish solution.
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The US Food and Drug Administration (US FDA) has classified the recall as a Class II hospital-level recall.
Shilpa Medicare said the recall was initiated voluntarily as a precaution, in consultation with and in accordance with the procedure prescribed by the US FDA. No adverse event has been reported to the company in respect of the affected batches.
“The recall has been initiated voluntarily by the company, out of an abundance of caution, in consultation with and in accordance with the procedure prescribed by the US FDA. No adverse event has been reported to the company in respect of the affected batches,” it added.
The recall is confined to the four affected batches and does not affect any other product of the company, its manufacturing arrangements or the supply of its products to customers.
Shilpa Medicare said it does not foresee any material impact from the recall on its financial position, operations or other affairs.
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In June this year, Shilpa Medicare Ltd said its wholly-owned subsidiary, Shilpa Biologicals Private Ltd (SBPL), had entered a co-development and supply agreement with Finland-based Orion Corporation for an intravenous (IV) nivolumab biosimilar for the European market.
In an exchange filing, the company said Shilpa Biologicals will co-develop, manufacture and exclusively supply the biosimilar from its biologics facility in Dharwad, Karnataka. At the same time, Orion will have exclusive rights to register, market, distribute and sell the product across Europe.
The agreement combines Shilpa’s biologics development and manufacturing capabilities with Orion’s commercial and regulatory expertise in Europe.
Nivolumab is one of the world’s most widely used immuno-oncology therapies. According to the company, the drug recorded approximately $4.1 billion in sales in Europe in 2025, citing IQVIA/IMS data.
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As per the agreement, Orion will act as the marketing authorisation holder for the product in Europe, while Shilpa Biologicals will serve as the exclusive long-term commercial manufacturer and supplier. Shilpa will also be eligible to receive development and regulatory milestone payments, in addition to supply revenue over the duration of the partnership. The financial terms of the agreement were not disclosed.
The company said the partnership aims to expand patient access to a high-quality biosimilar following the loss of exclusivity of the originator nivolumab in Europe.
“Extending our partnership with Orion into immuno-oncology is a defining moment for Shilpa Biologicals. It reflects the trust our partners place in our quality, our science and our ability to deliver complex biologics at scale,” Vishnukant Bhutada, Managing Director of Shilpa Medicare, said.
Shares of Shilpa Medicare Ltd ended at ₹810.10, up by ₹1.40, or 0.17%, on the BSE.
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